Improving Community Ambulation After Hip Fracture

Hip Fracture Clinical Trial

— CAP  

Official title:

Improving Community Ambulation After Hip Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783704
• Other study ID #: HP-00046956
• Secondary ID: 1R01AG035009-01A
• Status: Completed
• Phase: N/A
• Start date: June 10, 2013
• Est. completion date: October 17, 2017

Study information

• Verified date: January 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Activity and exercise are believed to be of benefit for reducing disability in older adults, yet the majority of older adults do not participate in regular exercise and is not active. This is especially true for older adults following hip fracture after they complete the usual rehabilitation program. This study is being done to compare two 16-week supervised multi-part physical therapy programs (interventions) initiated up to 26 weeks after hip fracture. The investigators want to test whether the interventions lead to improvements in a person's ability to walk on their own in the home and in the local community. With this knowledge the investigators hope to help a greater number of hip fracture patients enjoy a more complete recovery and improved overall health. ANCILLARY STUDY #1 - MECHANISTIC PATHWAYS TO COMMUNITY AMBULATION (CAP-MP) The goal of this ancillary study is to investigate several mechanisms thought to be related to recovery in ambulatory ability after hip fracture. Selected mechanistic pathways are being investigated by obtaining mechanistic measurements of the participants randomized in the University of Maryland, Baltimore (UMB) clinical site of CAP. ANCILLARY STUDY #2 - DIET AND DIETARY PATTERNS IN OLDER ADULTS UNDERGOING HIP FRACTURE REHABILITATION The goal of this ancillary study is to analyze dietary patterns for the nutritional characterization of older adults recovering from a hip fracture. The identified dietary patterns, as well as motivators and barriers to intake, will be assessed for their impact on the rate of return to community ambulation in participants randomized at the University of Connecticut Health Center (UCHC) clinical site of CAP. ANCILLARY STUDY #3 - ROLE OF GLUCOSE METABOLISM IN STRENGTH AND FUNCTIONAL RECOVERY AFTER HIP FRACTURE The goal of this ancillary study is to assess the impact of glucose metabolism on strength and functional performance following resistance training in participants randomized at the UCHC clinical site of CAP. ANCILLARY STUDY #4 - MUSCLE MECHANISMS UNDERLYING RECOVERY OF FUNCTION AFTER HIP FRACTURE The goal of this ancillary study is to understand some of the key muscle mechanisms associated with recovery in community ambulation following hip fracture in response to the two interventions for participants randomized at the Arcadia University (AU) clinical site of CAP.

Description:

MAIN STUDY Despite improvements in medical management, significant residual disability remains in older persons after a hip fracture. The goal of current clinical practice is independent, safe household ambulation two to three months after surgery. Hip fracture-acquired dependency in functional activities of daily living persists well beyond three months post-surgery. This residual disability indicates that current standard Medicare-reimbursed post-hip fracture rehabilitation (i.e., usual care) fails to return many patients to pre-fracture levels of function. In contrast to stroke and heart disease, other commonly occurring acute conditions in the older population, there are few intervention trials focused on decreasing disability following hip fracture. None of the trials for hip fracture has examined the effect of early post-fracture intervention on the ability to ambulate at a level required for independent function in the community (i.e., community ambulation). Thus, there is a paucity of evidence to justify extending medical management beyond usual care in persons following hip fracture to achieve community, rather than merely household, ambulation. A randomized controlled trial (RCT) including 210 older adults who have experienced a hip fracture will be carried out at three clinical sites with half of the subjects receiving a specific multi-component intervention (PUSH) and the other half receiving a non-specific multi-component intervention (PULSE). Randomization of 210 participants meeting eligibility criteria will take place after post-acute rehabilitation ends, approximately 6 months (26 weeks) after admission to the hospital for hip fracture. The primary endpoint will be measured using the Six-Minute Walk Test (SMWT) at the end of the 16-week intervention period. The goal is to enable older adults who have experienced a hip fracture to recover sufficiently to become community ambulators. Primary Aim The primary aim of the study is to determine if a specific multi-component 16-week intervention based on aerobic conditioning, specificity of training, and muscle overload (the PUSH intervention), initiated within 26 weeks of admission to the hospital for hip fracture, will be more successful in producing community ambulation at 16 weeks after randomization than a non-specific multi-component intervention of transcutaneous electrical nerve stimulation (TENS), flexibility activities, and active range of motion exercises (AROM) (the PULSE intervention). Secondary Aims 1. To determine whether the proportion of community ambulators differs between the PUSH and PULSE interventions at 40 weeks post-randomization and whether the difference in proportions at 40 weeks changed from the difference in proportions at 16 weeks 2. To compare the PUSH and PULSE interventions at 16 weeks and 40 weeks post-randomization with respect to five secondary outcomes that are thought to be precursors to community ambulation (endurance, dynamic balance, walking speed, quadriceps strength, and lower extremity function) 3. To compare the PUSH and PULSE interventions at 16 weeks and 40 weeks post-randomization with respect to several tertiary outcomes (activities of daily living, quality of life, physical activity, lower extremity physical performance, balance confidence, increase of 50 meters or more in distance walked in six minutes, nutritional status, cognitive status, and depressive symptoms) 4. To compare the economic value of the PUSH and PULSE interventions by estimating the impact of the interventions on cost per quality-adjusted life year (QALY) gained over the follow-up period. In addition to study outcome measures, expected adverse events (AEs) will be assessed every four weeks during a telephone interview. Information about reportable adverse events (RAEs), which include serious adverse events (SAEs), unexpected AEs, or injury that occurs under supervision by study staff, will be collected throughout the study. Vitamin D, calcium, and multivitamin adherence will be monitored by pill counts every four weeks during the intervention period and by self-report during the 4-week telephone calls. Adherence with the PT interventions will also be monitored. For participants randomized prior to version 10.0 of the protocol, follow-up assessment visits occurred 16 weeks and 40 weeks from the date of randomization and telephone interviews were conducted every four weeks during the 40-week study period for a total of 10 telephone interviews. For participants consented under version 10.0 of the protocol, all follow-up will end at 16 weeks post-randomization. In version 11.0 of the protocol, we will eliminate several secondary and tertiary outcome measures. In the description of outcome measures, we identify the measures that will not be collected for participants consented under protocol version 11.0 or later. ANCILLARY STUDIES ANCILLARY STUDY #1 - MECHANISTIC PATHWAYS TO COMMUNITY AMBULATION (CAP-MP) - Dr. Jay Magaziner [Ancillary Study #1 Start Date: April 12, 2014; Primary Completion Date: October 19, 2017; n=39] The CAP-MP ancillary study is intended to supplement the information gained from the parent CAP study, to help investigators understand how older adults recover after injury. Participants enrolled in the CAP parent study at the Baltimore site are invited to participate in the CAP-MP ancillary study and undergo additional testing at the same time points as for the parent CAP study. The objective of the CAP-MP ancillary study is to examine mechanistic factors hypothesized to be on the pathway between two 16-week interventions post-hip fracture and recovery and the ability to ambulate independently in the community. The effect of the interventions on these factors 24 weeks after the intervention ends also will be evaluated. The outcomes for the CAP-MP ancillary study are secondary or tertiary to the main CAP study. Primary Aim. To determine if, at the end of the 16-week intervention, participants in the PUSH group, compared to the PULSE group, have: a) greater muscle volume and attenuation (i.e., reduced intra-muscular fat) of the thigh; b) greater lower extremity strength; c) greater bone mineral density and bone strength; d) more bone formation and less bone resorption; e) lower levels of circulating inflammatory cytokines; f) higher levels of the hormones insulin-like growth factor (IGF)-1, testosterone, and estradiol; g) greater aerobic capacity; h) greater improvement in gait and balance; and i) better cognition and fewer depressive symptoms. Secondary Aim 1. To determine the long-term (i.e., 24 weeks after intervention ends) effect of the intervention on the mechanistic factors detailed in the primary aim. Secondary Aim 2. To evaluate the relationships between mechanistic factors detailed in the primary aim above and community ambulatory ability at the end of the intervention and 24 weeks later in order to identify those mechanisms that are most responsible for the ability to ambulate in the community following delivery of the intervention. Tertiary Aim. To quantify the mediating effect of mechanistic factors detailed in the primary aim on the relationship between the intervention and ability to ambulate in the community at the end of the intervention (16 weeks post-randomization) and 24 weeks later. ANCILLARY STUDY #2 - DIET AND DIETARY PATTERNS IN OLDER ADULTS UNDERGOING HIP FRACTURE REHABILITATION - Dr. Anne Kenny [n=11] This ancillary study will analyze dietary patterns for the nutritional characterization of older adults recovering from a hip fracture. The identified dietary patterns, as well as motivators and barriers to intake, will be assessed for their impact on the rate of return to community ambulation in the CAP study. Hypothesis: Those who consume dietary patterns similar to a Mediterranean style diet will have less malnutrition with greater likelihood for a return to community ambulation. Aim 1. At baseline determine degree of Mediterranean style diet intake and dietary patterns in our sample of hip fracture patients to correlate with nutritional status assessed by the Mini Nutritional Assessment tool (MNA). Aim 2. Determine motivators and barriers to intake in the hip fracture rehabilitation population and associate with dietary patterns and nutritional status. Aim 3. Diets determined at baseline will be used to predict community ambulation and similar primary endpoints for CAP. ANCILLARY STUDY #3 - ROLE OF GLUCOSE METABOLISM IN STRENGTH AND FUNCTIONAL RECOVERY AFTER HIP FRACTURE - Dr. Anne Kenny [n=21] The goal of this ancillary study is to assess the impact of glucose metabolism on strength and functional performance following resistance training in the population. Data on rehabilitation capacity post-fracture in those with diabetes mellitus (DM) are limited and mixed. Studies focusing on rehabilitation potential in DM demonstrate either no impact or a decrease in functional recovery. Hypothesis: Community-dwelling ambulatory hip fracture survivors with impaired glucose metabolism (measured as homeostasis model assessment-estimated insulin resistance [HOMA- IR] or diagnosis of DM) will not recover lower extremity strength or function as well as those with normal glucose metabolism in response to resistance exercise compared to non-resistance training. Further, investigators propose that higher AGE (measured as pentosidine level and its receptor) will impair strength and functional improvement with resistance exercise. Those with IR and DM have lower IGF-1 and higher levels of IGF binding proteins (IGFBP1 and 3) further limiting the available IGF-1 for tissue use. Investigators hypothesize that the strength and functional improvement from resistance exercise will be mitigated by higher IGFBP in those with DM and IR compared to those with normal glucose metabolism. Aim 1. To compare change in strength and function between those with diabetes mellitus, insulin resistance, or without either condition compared between two multi-component exercise interventions in which one includes resistance. Aim 2. To determine association between baseline AGE and IGF/IGFBP on strength and functional improvement and evaluate contribution of change in biomarkers to muscle/function response from resistance exercise. ANCILLARY STUDY #4 - MUSCLE MECHANISMS UNDERLYING RECOVERY OF FUNCTION AFTER HIP FRACTURE - Dr. Marty Eastlack [Ancillary Study #4 Start Date: April 6, 2015; Primary Completion Date: December 13, 2017; n=22] The purpose of this ancillary study is, therefore, to examine the effect of the two interventions on the precursors to participation in the community. Hypothesis: Those who participate in the PUSH intervention will have less impairment in body structure and function (muscle thickness and echo intensity), fewer limitations in activities (chair rate of rise and fast gait speed) and therefore better likelihood to return to participation (community ambulation). Aim 1: To determine if there is a difference between PUSH and PULSE with respect to change in muscle quality (muscle thickness and echo intensity), muscle power (chair rate of rise) and fast gait speed. Aim 2: To see if differences persist 40 weeks post-randomization. Aim 3: To see if changes in muscle quality predict faster gait speed, chair rate of rise and chair rise strategy (this is categorical) among all participants. Aim 4: To describe the quality of movement (chair rise strategy and capacity, standing symmetry, temporospatial aspects of gait) among all participants. Aim 5: To confirm that rate of rise in standing is a proxy for instrumented measure of lower extremity power.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: October 17, 2017
• Est. primary completion date: October 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Closed fracture of proximal femur
• Age 60 or older at time of randomization
• Minimal trauma fracture
• Non-pathologic fracture
• Surgical fixation of fracture
• Living in the community at time of fracture
• Ambulating without human assistance 2 months prior to fracture
• Unable to walk 300 m or more in 6 minutes without human assistance at time of randomization

Exclusion Criteria:

• Not English speaking
• Does not live within reasonable distance of the clinical center
• End stage renal disease on dialysis
• Recent myocardial infarction
• Uncompensated congestive heart failure
• Lower extremity amputation
• Symptoms of angina pectoris
• Chest pain or shortness of breath (including from severe COPD)
• Participant plans to move out of area or otherwise be unavailable during the 16-week intervention period
• Participation in another clinical trial
• Not community-residing (e.g., resident of a skilled nursing facility) at time of randomization
• Not fully weight-bearing on fractured leg or non-fractured leg at time of randomization
• Calculated creatinine clearance < 15 ml/min
• Serum albumin < 2.5 g/dl
• Hemoglobin < 9 g/dl
• Receiving physical therapy for the hip fracture in the hospital or inpatient rehabilitation facility at time of randomization
• Severely diminished lower extremity sensation or ulceration
• Uncontrolled hypertension
• Denied medical clearance by appropriate medical provider
• Clinical site clinician thinks participant is not a good candidate for study (e.g., not likely to survive study period)
• Cognitive impairment (3MS score <73)
• Development of chest pain or substantial shortness of breath or ambulating with severe pain during baseline SMWT
• Participant walks less than 4 meters in 40 seconds (<0.1 m/sec) during baseline SMWT
• Not randomized by 26 weeks post admission for hip fracture
• Final sign-off from study clinician and/or principal investigator is incomplete
• Incomplete baseline data
• Unable to contact participant
• Participant is unable to provide her/his own informed consent
• Participant refuses the study

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Dietary Supplement:
• Nutrition
Participants receive 2000 IU vitamin D3, 600 mg calcium, and a multivitamin daily for the duration of the study. Nutritional counseling is also provided. Participants are screened at time of randomization to assess nutritional risk using the Mini Nutritional Assessment-Short Form and contacted by a registered dietician (RD) within 7 days of randomization. Those who score =7 (malnourished) and participants with baseline serum albumin 2.5-3.5 g/dl receive a visit from an RD with follow-up a week later. Participants who score 8-11 (at risk of malnutrition) and have serum albumin level >3.5 g/dl receive a phone call from the RD and may receive an in-person visit if warranted. Those screening in the normal range (12-14) and have serum albumin level >3.5 g/dl receive a phone call from the RD. Weight is monitored every 4 weeks. Those who lose 2% or more body weight receive a call from the RD. Those who lose 5% or more body weight between baseline and follow-up may be referred to an RD.

Behavioral:
• PUSH
Strength components of the muscle performance intervention are performed using a portable progressive resistive exercise device (Shuttle® MiniPress, Contemporary Design Company, P.O. Box 5089, Glacier, Washington 98244). Muscle performance focuses on bilateral hip extensors, hip abductors, knee extensors, and plantar flexors. Balance and strength are addressed with additional exercises performed while standing. The endurance intervention begins with 2-3 minutes of continuous upper and lower extremity active range of motion (AROM) with the participant sitting in order to increase the participants' heart rate (HR) or exertion closer to the target zone. The participant is then asked to walk on level surfaces and/or up and down steps to keep the HR within the training zone for 20 minutes.
• PULSE
During the AROM exercises, participants work to increase flexibility and range of motion. Exercises include the neck, shoulders, arms, trunk, hips, knees and ankles. During all AROM exercises, the participant focuses on deep breathing techniques. The second part of the session uses transcutaneous electrical nerve stimulation (TENS) on lower extremity muscle groups to decrease pain, thereby allowing greater ease of mobility. TENS uses low-level electrical current to stimulate superficial cutaneous nerve fibers through the skin. Flexible carbonized, disposable electrodes coated with a self-adhesive conductive polymer will be applied to the skin bilaterally near the motor points on muscle bellies (the gluteal complex, the quadriceps, and the gastrocnemius) for 7 minutes per muscle group.

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Arcadia University	Glenside	Pennsylvania
United States	Dartmouth Medical School	Lebanon	New Hampshire

Sponsors (5)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Arcadia University, Dartmouth-Hitchcock Medical Center, National Institute on Aging (NIA), UConn Health

Country where clinical trial is conducted

United States, 

References & Publications (60)

Andrews AW, Thomas MW, Bohannon RW. Normative values for isometric muscle force measurements obtained with hand-held dynamometers. Phys Ther. 1996 Mar;76(3):248-59. — View Citation

ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):1185. — View Citation

Bickel G, Nord M, Price C, Hamilton W, Cook J. Guide to Measuring Household Food Security, Revised 2000. In: U.S. Department of Agriculture FaNS, editor. Alexandria, VA 2000.

Binder EF, Brown M, Sinacore DR, Steger-May K, Yarasheski KE, Schechtman KB. Effects of extended outpatient rehabilitation after hip fracture: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):837-46. — View Citation

Binder EF, Schechtman KB, Ehsani AA, Steger-May K, Brown M, Sinacore DR, Yarasheski KE, Holloszy JO. Effects of exercise training on frailty in community-dwelling older adults: results of a randomized, controlled trial. J Am Geriatr Soc. 2002 Dec;50(12):1921-8. — View Citation

Bohannon RW, Andrews AW. Interrater reliability of hand-held dynamometry. Phys Ther. 1987 Jun;67(6):931-3. — View Citation

Bohannon RW. Reference values for extremity muscle strength obtained by hand-held dynamometry from adults aged 20 to 79 years. Arch Phys Med Rehabil. 1997 Jan;78(1):26-32. — View Citation

Bohannon RW. Test-retest reliability of hand-held dynamometry during a single session of strength assessment. Phys Ther. 1986 Feb;66(2):206-9. — View Citation

Chang KP, Center JR, Nguyen TV, Eisman JA. Incidence of hip and other osteoporotic fractures in elderly men and women: Dubbo Osteoporosis Epidemiology Study. J Bone Miner Res. 2004 Apr;19(4):532-6. Epub 2004 Jan 5. — View Citation

Dipietro L, Caspersen CJ, Ostfeld AM, Nadel ER. A survey for assessing physical activity among older adults. Med Sci Sports Exerc. 1993 May;25(5):628-42. — View Citation

Enright PL, McBurnie MA, Bittner V, Tracy RP, McNamara R, Arnold A, Newman AB; Cardiovascular Health Study. The 6-min walk test: a quick measure of functional status in elderly adults. Chest. 2003 Feb;123(2):387-98. — View Citation

Enright PL, Sherrill DL. Reference equations for the six-minute walk in healthy adults. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1384-7. Erratum in: Am J Respir Crit Care Med. 2020 Feb 1;201(3):393. — View Citation

Freedman VA. Adopting the ICF language for studying late-life disability: a field of dreams? J Gerontol A Biol Sci Med Sci. 2009 Nov;64(11):1172-4; discussion 1175-6. doi: 10.1093/gerona/glp095. Epub 2009 Jul 17. — View Citation

Fukumoto Y, Ikezoe T, Tateuchi H, Tsukagoshi R, Akiyama H, So K, Kuroda Y, Yoneyama T, Ichihashi N. Muscle mass and composition of the hip, thigh and abdominal muscles in women with and without hip osteoarthritis. Ultrasound Med Biol. 2012 Sep;38(9):1540-5. doi: 10.1016/j.ultrasmedbio.2012.04.016. Epub 2012 Jun 30. — View Citation

Guigoz Y, Vellas B, Garry PJ. Assessing the nutritional status of the elderly: The Mini Nutritional Assessment as part of the geriatric evaluation. Nutr Rev. 1996 Jan;54(1 Pt 2):S59-65. Review. — View Citation

Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. — View Citation

Guralnik JM, Seeman TE, Tinetti ME, Nevitt MC, Berkman LF. Validation and use of performance measures of functioning in a non-disabled older population: MacArthur studies of successful aging. Aging (Milano). 1994 Dec;6(6):410-9. — View Citation

Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. — View Citation

Guyatt GH, Sullivan MJ, Thompson PJ, Fallen EL, Pugsley SO, Taylor DW, Berman LB. The 6-minute walk: a new measure of exercise capacity in patients with chronic heart failure. Can Med Assoc J. 1985 Apr 15;132(8):919-23. — View Citation

Hatch J, Gill-Body KM, Portney LG. Determinants of balance confidence in community-dwelling elderly people. Phys Ther. 2003 Dec;83(12):1072-9. — View Citation

Kaiser MJ, Bauer JM, Ramsch C, Uter W, Guigoz Y, Cederholm T, Thomas DR, Anthony P, Charlton KE, Maggio M, Tsai AC, Grathwohl D, Vellas B, Sieber CC; MNA-International Group. Validation of the Mini Nutritional Assessment short-form (MNA-SF): a practical tool for identification of nutritional status. J Nutr Health Aging. 2009 Nov;13(9):782-8. — View Citation

Koval KJ, Cooley MR. Clinical pathway after hip fracture. Disabil Rehabil. 2005 Sep 30-Oct 15;27(18-19):1053-60. — View Citation

Lindemann U, Claus H, Stuber M, Augat P, Muche R, Nikolaus T, Becker C. Measuring power during the sit-to-stand transfer. Eur J Appl Physiol. 2003 Jun;89(5):466-70. Epub 2003 Apr 24. — View Citation

Lindemann U, Muche R, Stuber M, Zijlstra W, Hauer K, Becker C. Coordination of strength exertion during the chair-rise movement in very old people. J Gerontol A Biol Sci Med Sci. 2007 Jun;62(6):636-40. — View Citation

Locher JL, Ritchie CS, Roth DL, Sen B, Vickers KS, Vailas LI. Food choice among homebound older adults: motivations and perceived barriers. J Nutr Health Aging. 2009 Oct;13(8):659-64. — View Citation

Lotz JC, Cheal EJ, Hayes WC. Stress distributions within the proximal femur during gait and falls: implications for osteoporotic fracture. Osteoporos Int. 1995;5(4):252-61. — View Citation

Magaziner J, Fredman L, Hawkes W, Hebel JR, Zimmerman S, Orwig DL, Wehren L. Changes in functional status attributable to hip fracture: a comparison of hip fracture patients to community-dwelling aged. Am J Epidemiol. 2003 Jun 1;157(11):1023-31. — View Citation

Magaziner J, Hawkes W, Hebel JR, Zimmerman SI, Fox KM, Dolan M, Felsenthal G, Kenzora J. Recovery from hip fracture in eight areas of function. J Gerontol A Biol Sci Med Sci. 2000 Sep;55(9):M498-507. — View Citation

Miyatani M, Kanehisa H, Ito M, Kawakami Y, Fukunaga T. The accuracy of volume estimates using ultrasound muscle thickness measurements in different muscle groups. Eur J Appl Physiol. 2004 Mar;91(2-3):264-72. Epub 2003 Oct 21. — View Citation

Mossey JM, Knott K, Craik R. The effects of persistent depressive symptoms on hip fracture recovery. J Gerontol. 1990 Sep;45(5):M163-8. — View Citation

Palombaro KM, Craik RL, Mangione KK, Tomlinson JD. Determining meaningful changes in gait speed after hip fracture. Phys Ther. 2006 Jun;86(6):809-16. — View Citation

Peeters P, Mets T. The 6-minute walk as an appropriate exercise test in elderly patients with chronic heart failure. J Gerontol A Biol Sci Med Sci. 1996 Jul;51(4):M147-51. — View Citation

Perera S, Mody SH, Woodman RC, Studenski SA. Meaningful change and responsiveness in common physical performance measures in older adults. J Am Geriatr Soc. 2006 May;54(5):743-9. — View Citation

Pescatello L, DiPietro L, Fargo A, Ostfeld A, Nadel E. The impact of physical activity and physical fitness on health indicators among older adults. Journal of Aging and Physical Activity 2: 2-13, 1994.

Petrella RJ, Payne M, Myers A, Overend T, Chesworth B. Physical function and fear of falling after hip fracture rehabilitation in the elderly. Am J Phys Med Rehabil. 2000 Mar-Apr;79(2):154-60. — View Citation

Pillen S, Tak RO, Zwarts MJ, Lammens MM, Verrijp KN, Arts IM, van der Laak JA, Hoogerbrugge PM, van Engelen BG, Verrips A. Skeletal muscle ultrasound: correlation between fibrous tissue and echo intensity. Ultrasound Med Biol. 2009 Mar;35(3):443-6. doi: 10.1016/j.ultrasmedbio.2008.09.016. Epub 2008 Dec 10. — View Citation

Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. — View Citation

Radloff LS. The CES-D Scale: A self-report depression scale for research in the general population. Applied psychological measurement 1: 385-401, 1977.

Rejeski WJ, Ettinger WH Jr, Schumaker S, James P, Burns R, Elam JT. Assessing performance-related disability in patients with knee osteoarthritis. Osteoarthritis Cartilage. 1995 Sep;3(3):157-67. — View Citation

Rejeski WJ, Fielding RA, Blair SN, Guralnik JM, Gill TM, Hadley EC, King AC, Kritchevsky SB, Miller ME, Newman AB, Pahor M. The lifestyle interventions and independence for elders (LIFE) pilot study: design and methods. Contemp Clin Trials. 2005 Apr;26(2):141-54. — View Citation

Rejeski WJ, Ip EH, Marsh AP, Miller ME, Farmer DF. Measuring disability in older adults: the International Classification System of Functioning, Disability and Health (ICF) framework. Geriatr Gerontol Int. 2008 Mar;8(1):48-54. doi: 10.1111/j.1447-0594.2008.00446.x. — View Citation

Resnick B, Magaziner J, Orwig D, Zimmerman S. Evaluating the components of the Exercise Plus Program: rationale, theory and implementation. Health Educ Res. 2002 Oct;17(5):648-58. — View Citation

Reuben DB, Siu AL. An objective measure of physical function of elderly outpatients. The Physical Performance Test. J Am Geriatr Soc. 1990 Oct;38(10):1105-12. — View Citation

Rosenberg JG, Ryan ED, Sobolewski EJ, Scharville MJ, Thompson BJ, King GE. Reliability of panoramic ultrasound imaging to simultaneously examine muscle size and quality of the medial gastrocnemius. Muscle Nerve. 2014 May;49(5):736-40. doi: 10.1002/mus.24061. — View Citation

Rubenstein LZ, Harker JO, Salvà A, Guigoz Y, Vellas B. Screening for undernutrition in geriatric practice: developing the short-form mini-nutritional assessment (MNA-SF). J Gerontol A Biol Sci Med Sci. 2001 Jun;56(6):M366-72. — View Citation

Sayetta RB, Johnson DP. Basic data on depressive symptomatology. United States, 1974-75. Vital Health Stat 11. 1980 Apr;(216):i-v, 1-37. — View Citation

Schenkman M, Berger RA, Riley PO, Mann RW, Hodge WA. Whole-body movements during rising to standing from sitting. Phys Ther. 1990 Oct;70(10):638-48; discussion 648-51. — View Citation

Steptoe A, Pollard TM, Wardle J. Development of a measure of the motives underlying the selection of food: the food choice questionnaire. Appetite. 1995 Dec;25(3):267-84. — View Citation

Thomaes T, Thomis M, Onkelinx S, Coudyzer W, Cornelissen V, Vanhees L. Reliability and validity of the ultrasound technique to measure the rectus femoris muscle diameter in older CAD-patients. BMC Med Imaging. 2012 Apr 2;12:7. doi: 10.1186/1471-2342-12-7. — View Citation

Vailas LI, Nitzke SA, Becker M, Gast J. Risk indicators for malnutrition are associated inversely with quality of life for participants in meal programs for older adults. J Am Diet Assoc. 1998 May;98(5):548-53. — View Citation

VanSwearingen JM, Brach JS. Making geriatric assessment work: selecting useful measures. Phys Ther. 2001 Jun;81(6):1233-52. Review. — View Citation

Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. Review. — View Citation

Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. — View Citation

Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 Health Survey: Manual and Interpretation Guide. Boston, Mass.: Nimrod Press; 1993.

Weissman MM, Sholomskas D, Pottenger M, Prusoff BA, Locke BZ. Assessing depressive symptoms in five psychiatric populations: a validation study. Am J Epidemiol. 1977 Sep;106(3):203-14. — View Citation

Wells JL, Dumbrell AC. Nutrition and aging: assessment and treatment of compromised nutritional status in frail elderly patients. Clin Interv Aging. 2006;1(1):67-79. — View Citation

Whitehead C, Miller M, Crotty M. Falls in community-dwelling older persons followinig hip fracture: impact on self-efficacy, balance and handicap. Clin Rehabil. 2003 Dec;17(8):899-906. — View Citation

Whittaker JL, Emery CA. Sonographic measures of the gluteus medius, gluteus minimus, and vastus medialis muscles. J Orthop Sports Phys Ther. 2014 Aug;44(8):627-32. doi: 10.2519/jospt.2014.5315. Epub 2014 Jul 16. — View Citation

Wilson MM, Thomas DR, Rubenstein LZ, Chibnall JT, Anderson S, Baxi A, Diebold MR, Morley JE. Appetite assessment: simple appetite questionnaire predicts weight loss in community-dwelling adults and nursing home residents. Am J Clin Nutr. 2005 Nov;82(5):1074-81. — View Citation

Zimmerman SI, Smith HD, Gruber-Baldini A, et al. Short-term persistent depression following hip fracture: a risk factor and target to increase resilience in elderly people. Social Work Research 23:187-96, 1999.

* Note: There are 60 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Activities of daily living (ADLs)	We will measure ADLs using the Pepper Assessment Tool for Disability (PAT-D) with two modifications. First, two items (walking a quarter mile and walking across a small room) were added to address perceived gaps in the original PAT-D scale. This modification is consistent with the version used in the Lifestyle Interventions and Independence for Elders study. Second, two items (walking several blocks and lifting heavy objects) were deleted to avoid duplication with other items in the scale. The resulting 19-item scale allows examination of three subscales (basic ADL, functional limitations, and instrumental ADL).; This measure will not be collected for participants consented under protocol version 11.0 or later.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Quality of life (SF-36)	We will use an interviewer-administered version of the SF-36, a health survey that assesses quality of life in eight subscales (physical function, social function, role-physical, role-emotional, bodily pain, mental health, general health, and vitality). The measure has been validated as a generic measure of quality of life in many different populations, including patient and non-patient samples.; This measure will not be collected for participants consented under protocol version 11.0 or later.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Balance confidence	The Activities-specific Balance Confidence (ABC) scale is a 16-item measure that asks respondents to rate their confidence in maintaining their balance while doing daily activities. Test-retest reliability, internal consistency, and concurrent validity with fall and physical activity are high. This measure has been used successfully in hip fracture patients.; This measure will not be collected for participants consented under protocol version 11.0 or later.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Yale Physical Activity Survey (YPAS)	This interviewer-administered questionnaire includes five categories of common activities related to work, exercise, and recreation performed during a typical week in the past month. The YPAS increases the sensitivity of other physical activity surveys by describing a wider range of lower intensity activities that older adults often engage in. Participation in each activity (hrs/week) will be multiplied by an intensity code (kcal/min) and then summed over all activities to calculate a weekly energy expenditure summary. The measure has been validated against several physiological variables of habitual activity. The YPAS has been used to estimate change in older adults in an exercise intervention program.; This measure will not be collected for participants consented under protocol version 11.0 or later.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Improvement in walking	Whether or not there was an increase of at least 50 meters in the distance walked on the SMWT will be assessed as a tertiary outcome. This distance has been shown to be clinically meaningful.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Depressive symptoms	Depressive symptoms will be measured using the 20-item Center for Epidemiologic Studies Depression (CES-D) scale, which asks about depressive symptoms experienced in the previous week. There is evidence that recovery post-fracture is delayed in the presence of depression. This scale ranges from 0-60 with higher scores indicating greater depression.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Cognitive status	Cognitive status will be assessed at follow-up using the 3MS.; This measure will not be collected for participants consented under protocol version 11.0 or later.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Nutritional status	Nutritional status will be assessed using the Mini Nutritional Assessment-Short Form (MNA®-SF), a validated and widely used malnutrition screening tool. We are using a modified version of the MNA®, approved by the scale's developer (the Nestlé company), to facilitate use as an interviewer-administered tool in a research setting. Scores range from 0 to 14; participants scoring =7 will be considered malnourished; those scoring 8-11 will be considered to be at risk of malnutrition; and those scoring 12-14 will be considered to have normal nutritional status.; This measure will not be collected at follow-up for participants consented under protocol version 12.0 or later.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #1 - Muscle and fat mass	Muscle and lean mass will be estimated using dual-energy x-ray absorptiometry (DXA) (GE LUNAR, Madison, WI). DXA calculates fat mass (g) and muscle mass (g) from the total body scan and values are provided in the report produced by the DXA machine. The coefficient of variation of these measurements in our previous studies for fat and lean mass was 1.4% and 1.3%, respectively.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #1 - Muscle composition: Intramuscular fat and muscle volume	Intramuscular fat and muscle volume are calculated when analyzing the thigh CT scan. Thigh CT will be performed every 4 cm starting at the patella and ending at the femoral head (Siemens Somatom Sensation 64 Scanner) to quantify skeletal muscle area, total fat area, low density lean tissue area, and muscle attenuation of the thigh. Scans will be analyzed using MIPAV (Medical Image Processing, Analysis and Visualization, v.7.0, NIH). The cross-sectional area of each axial slice will be multiplied by the distance between slices (4 cm) and summed across slices representing volume expressed in cm3. The average attenuation of muscle tissue and the percentage of low-density lean muscle to total muscle volume is associated with skeletal muscle lipid (fat) content, and a measure of muscle quality.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #1 - Strength	A Biodex System 3 PRO dynamometer will measure concentric isokinetic peak normalized joint torque over the entire range of motion (strength) for bilateral ankle plantarflexion-dorsiflexion and knee flexion-extension. Strength is measured in Newton-meters (Nm). Testing will utilize standardized positioning and joint motion excursions. Subjects will perform two blocks of three repetitions with a rest period between blocks.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #1 - Power	A Biodex System 3 PRO dynamometer will measure strength per unit of time (power) for bilateral ankle plantarflexion-dorsiflexion and knee flexion-extension. Power is measured in Watts (W). Testing will utilize standardized positioning and joint motion excursions. Subjects will perform two blocks of three repetitions with a rest period between blocks.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #1 - Bone mineral density (BMD)	BMD will be estimated using DXA as described above. DXA of the contralateral (non-fractured) femur will be measured to yield measures of total hip and femoral neck BMD.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #1 - Bone geometry	Bone geometry will be measured with the Hip Structural Analysis (HSA) program. The program uses DXA images to derive cross-section dimensions at defined regions traversing the femur, i.e., narrow neck, intertrochanter, and proximal shaft. At each region, BMD, bone cross-sectional area (CSA), outer diameter, cross-sectional moment of inertia, section modulus, and centroid are measured. Estimates of average cortical thickness and buckling ratio are derived using assumptions of cross-section shape.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #1 - Bone turnover markers	Bone turnover markers. a) bone formation (serum aminoterminal propeptide of type 1 procollagen; P1NP) and b) bone resorption (serum cross-linked C-telopeptides of type I collagen; CTx-I) will be assessed.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #1 - Hormones	a) Total testosterone (T) will be measured using the liquid chromatography-tandem mass spectrometry (LCMS/MS) method. b) Estradiol (E2) (Ultra-sensitive E2) will be measured by ELISA. c) Insulin-like growth factor-1(IGF-1) will be measured by RIA, using acid ethanol extraction. d) SHBG will be measured by IRMA. e) 25-hydroxyvitamin D (25-OH D) will be measured by RIA using kits supplied by DiaSorin (Stillwater, MN). This assay detects both the D2 and D3, f) Parathyroid hormone, intact (iPTH) will be measured by ELISA.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #1 - Inflammatory cytokines	a) interleukin-6 (IL-6), b) soluble TNF- a receptor 1 (sTNF- aR1), c) IL-1 receptor antagonist (IL-1ra), and d) interleukin-10 (IL-10). All cytokines will me measured in serum by ELISA (R&D Systems Inc., Minneapolis, MN).	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #1 - Aerobic capacity	VO2 peak will be measured using a treadmill with a custom constant velocity protocol with open circuit spirometry for measurement of aerobic capacity (Ametek-Thermox) O2 and CO2 analyzers (Sensormedics 2900 metabolic cart with re-breathing cardiac output option) using a method that has been previously employed in subjects with hemiparetic stroke recent hip fracture.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #1 - Gait and balance (GAITrite)	A GAITrite instrumented walkway system will measure spatial and temporal gait parameters. Subjects will walk at their safest fast and natural speeds. In addition, the Dynamic Gait Index, a clinical assessment of balance and mobility while walking, will be administered. Measures will include: step length, walking speed, single and double leg support time, and cadence.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #1 - Gait and balance (Stepping Test)	Subjects will stand on two separate force platforms with reflective motion detection markers placed on each foot to record stepping kinematics. Visually cued simple and choice stepping reaction time (RT) tasks will evaluate the rapid initiation of forward stepping. Measures will be response, weight transfer, and movement times, number of false starts and stepping performance. Neuromotor and biomechanical features of balance and gait control will be extracted.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #1 - Gait and balance (Four Square Step Test)	It was developed as an easily portable and reliably scored test of balance and ambulatory coordination, and standardized locally according to detailed usage in the literature. Essentially, the subject is timed while stepping into "4 squares" over lines or canes placed on the floor in a "+" pattern moving both clockwise then back counter-clockwise. This will be performed by an exercise physiologist or nurse experienced in its application, using an SOP that has been reviewed by PTRS faculty. The rationale for including this test in addition to the more mechanistic gait and stepping tests above includes its well established clinical relevance and ease of interpretation of change in score over time.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #1 - Cognitive function (Trail Making Test (Trails A & B))	The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. It is sensitive to detecting cognitive impairment associated with dementia.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #1 - Cognitive function (Hooper Visual Organization Test (VOT))	The Hooper VOT is a neuropsychological test of visual spatial ability that presents participants with a line drawing of a common object that has been broken into fragments, and asks participants to name what the object would be if reassembled.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #2 - Food Frequency Questionnaire (FFQ)	Data collected from the Harvard FFQ includes foods, food groups, and frequency of intake that is averaged by respondents to represent intake over the previous year. This questionnaire is validated against diet record for correlations between nutrients and food intake. Participants will complete the FFQ at home, on their own time. Instructions for completion will be altered to report intake since their hip fracture.	Baseline
Other	Ancillary Study #2 - 24 Hour Dietary Recall	The diet record (DR) provides a snapshot of current intake. The 7-day weighted DR is considered the gold standard for subjective dietary assessment and the 24 hour DR has been validated in older adults. Participants will record all foods and beverages eaten, the amount consumed and time of consumption in the previous 24 hours. Food models, scales, and examples will be provided to guide the participant to most accurately report intake. Participants will be asked if the 24 hour DR is representative of their intake prior to hip fracture.	Baseline
Other	Ancillary Study #2 - Food Barriers and Motivators Survey	To assess potential reasons for poor intake or post-hip fracture alterations in their eating behaviors, investigators will inquire about barriers and motivators of food intake including: food security, appetite and sensory appeal, oral health, perception of health and resources, and social factors. To meet the needs of this study, investigators will modify other validated surveys. Surveys used in the development of this survey include the Guide to Measuring Household Food Security from the USDA to assess food security; the Simplified Nutritional Appetite Questionnaire (SNAQ) to access appetite; Vailas' Food Enjoyment Questionnaire to identify barriers of intake; and the Food Choice Questionnaire (FCQ) to assess motivators of food intake.	Baseline
Other	Ancillary Study #4 - Muscle thickness and quality	There are no additional exclusion criteria for the ultrasound measures and no known risks associated with these measures as ultrasound does not use ionizing radiation to acquire images. Muscle quality (thickness and echo intensity) of the gluteus medius, rectus femoris, and lateral heads of the gastrocnemius will be measured using an ultrasound unit (GE - LOGIQ e). Participants will be in a private room and asked to lie in side-lying with their hip and lower leg exposed in order to measure the gluteus medius and lateral gastrocnemius. They will be draped with a sheet for modesty as necessary. Participants will then be asked to roll onto their backs with their front thigh exposed in order to measure the rectus femoris. Ultrasonographic images will be taken bilaterally. The images (which have no identifiers; only their study code) will be downloaded onto a computer and later analyzed using Image J.	Baseline, 16 weeks post-randomization, and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #4 - Sit-to-stand (video and forceplate)	Participants will do the sit-to-stand (STS) test from both a standard and adjustable height chair (adjusted to 80% of tibial length with shoes). Participants are instructed to place their arms across their chest throughout the STS maneuver. If unable to do this participants are allowed to use their arms. Participants' feet are placed parallel with each foot on a different forceplate with knees at a 90 degree angle; the width is unrestrained, but consistent throughout trials. The STS test includes 3 trials at the participant's preferred speed then 3 trials as fast as and as slow as possible with rest as needed. A video camera is positioned in the frontal and sagittal plane to record the strategy used to rise from the chair. Participants will come to standing onto forceplates that measure vertical ground reaction force under each leg, the rate at which they rise from the chair at three different speed commands, and the time range between fast and slow trials as a measure of capacity.	Baseline, 16 weeks post-randomization, and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #4 - Lower extremity power (Primus)	The participant will be placed on a machine (Primus) that will allow the measurement of lower extremity power during the "leg press exercise" movement. First, the participant will be given several practice trials and the test will only begin after they demonstrate understanding of the task. The participant will then be asked to do this movement against three different resistances (set to 30, 40, and 50% of body weight) for a total of up to 15 trials; 5 at each percentage of body weight. We will be looking for 3 trials that are consistent (= 5% coefficient of variation among trials) and as soon as this is done the participant will proceed to the next resistance level. In our pilot study with healthy elders (age range 58-88; 75 + 12 yrs) all participants were able to achieve 3 consistent trials within the specified five trials with no adverse events.	Baseline, 16 weeks post-randomization, and 40 weeks post-randomization for a subset of participants
Other	Ancillary Study #4 - Temporospatial measures of walking (Gait Mat)	Temporal and spatial characteristics of gait will be measured with the Gait Mat II (EQ, Inc., Telford, PA). The participant will be instructed to walk at usual, fast and as slowly as possible without stopping. Individually determined rest periods will be given between the trials. The Gait Mat II ™ is connected to a personal computer and collects average walking speed (m/sec) and calculates step length as the spatial distance between the location of the first switch closure of one footprint and the location of the first switch closure of the previous footprint on the contralateral side. Single support time is calculated as the time from the last switch opening of one step to the first switch closure of the next step. Left single support time is the same as right swing time.	Baseline, 16 weeks post-randomization, and 40 weeks post-randomization for a subset of participants
Primary	Ability to walk 300 meters or more in six minutes	The primary study outcome reflects the concept of a minimum distance a person needs to be able to walk to carry out usual activities in the community. This will be defined as achieving the threshold value of 300 meters or more on the Six-Minute Walk Test (SMWT). The SMWT is an assessment with excellent psychometric properties, and there is sound justification for a 300 m distance threshold on the SMWT (equivalent to walking at 0.8 m/s) to serve as an indicator for community ambulatory ability.	16 weeks post-randomization
Secondary	Ability to walk 300 meters or more in six minutes	Performance of the SMWT (described above) will be used to determine whether the proportion of community ambulators differs between the PUSH and PULSE interventions at 40 weeks post-randomization and whether the difference in proportions at 40 weeks changed from the difference in proportions at 16 weeks.	40 weeks post-randomization
Secondary	Endurance	To assess endurance, the SMWT (described above) will be used to obtain a continuous measure of total distance walked in six minutes. The SMWT is highly correlated with workloads, heart rate, oxygen saturation, and dyspnea responses when compared to bicycle ergometry and treadmill exercise tests in older persons. It has been performed by elderly, frail and severely compromised participants who cannot perform standard maximal treadmill or cycle ergometry exercise tests.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Secondary	Balance	We will use an enhanced balance measure that includes the balance subscale of the Short Physical Performance Battery (SPPB) and two additional single leg stands (eyes open and eyes closed), as used in the National Health and Aging Trends Study (NHATS). For the test of standing balance, participants are asked to maintain balance in three positions, characterized by a progressive narrowing of the base support (side-by-side, semi-tandem, and tandem). For each of the three positions, participants are timed to a maximum of 10 seconds. Participants are then asked to stand on one leg (on the side of the fracture) with eyes open and again with eyes closed. Each of the single leg stands are held for up to 30 seconds. The number of seconds is then summed across the 5 items to obtain the measure of balance. These tests are hierarchical such that when a participant fails an item, the harder ones are not administered and receive a score of 0.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Secondary	Quadriceps muscle strength	Isometric force for bilateral knee extensors will be measured with a portable, hand-held dynamometer (Microfet2 Manual Muscle Tester). Participants will be seated on the strength testing chair to increase stabilization, with hip flexion 90° and knee flexed to 70°, stabilization straps on the pelvis and thigh, and resistance applied just proximal to the ankle on the anterior surface of the leg. Participants will be asked to push as hard and as fast as possible for five seconds. Three maximal effort trials, with a one-minute rest between trials, will be performed. The reported test-retest reliability with hand-held dynamometry is excellent (r>.90) if tested in one session and in subjects with muscle weakness (intraclass correlation coefficient = .90). The peak force will be recorded for each of the three trials and the highest value will be used.; This measure will not be collected for participants consented under protocol version 11.0 or later.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Secondary	Lower extremity function	A modified version of the Physical Performance Test (mPPT) will be used to measure lower extremity function at baseline and follow-up. The modification, used by Binder et al., substitutes a chair-rise task and a balance task for writing and eating tasks, in order to emphasize lower extremity function. The modified PPT includes nine standardized tasks that will be timed (e.g., picking up a penny from the floor, standing up five times from a 16-inch chair). The tasks are performed twice and the times from the two trials are averaged. The score for each item ranges from 0 to 4, with 36 representing a perfect score. Test-retest reliability for the modified PPT score is 0.96. Because there is some overlap between the mPPT and SPPB items, we have integrated the two scales so that participant burden is minimized but it is still possible to obtain scores on each of the scales.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Secondary	Fast walking speed	Within the mPPT, participants are asked to walk a distance of 50 feet walking quickly but safely. The time required to walk 50 ft will be the measure of fast walking speed.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants
Secondary	Cost effectiveness: health care utilization	The economic value of the interventions will be determined by assessing the impact on quality-adjusted life years (QALYs), cost, and cost per QALY gained over the 16 weeks following randomization. The cost-effectiveness analyses will address both the within trial comparison of the study interventions and a model-based comparison of the study interventions and usual care.; This measure will not be collected for participants consented under protocol version 11.0 or later.	Every four weeks, up to 16 weeks post-randomization and up to 40 weeks post-randomization for a subset of participants
Secondary	Short Physical Performance Battery (SPPB)	The SPPB evaluates lower extremity performance in older persons based on timed short distance walk, repeated chair stands, and a set of balance tests. Each of the tasks is assigned a score ranging from 0 to 4, with 4 indicating the highest level of performance and 0 an inability to complete the test. The test takes about 10-15 minutes to administer and was designed to be administered by a lay interviewer in a setting with limited space. The battery has an excellent safety record. It has been administered to well over 10,000 persons in various studies and no serious injuries are known to have occurred. The SPPB components and total score are derived from normative values obtained from a population-based study.	16 weeks post-randomization and 40 weeks post-randomization for a subset of participants