Enhancing Rehabilitation After Hip Fracture

Hip Fracture Clinical Trial

Official title:

Enhanced Rehabilitation Targeting Strength and Movement Pattern Symmetry Following Hip Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02635308
• Other study ID #: 00062639
• Status: Completed
• Phase: N/A
• First received: November 30, 2015
• Last updated: December 15, 2015
• Start date: April 2013
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study evaluates the feasibility of implementing a unilaterally biased high-intensity resistance training to facilitate restorative vs. compensatory recovery after "usual care" physical therapy among older adults who have recently incurred a hip fracture. Additionally, physical performance during a sit-to-stand task, muscle function (strength/power), physical function measures, muscle composition, and muscle quality (force/unit area), are assessed before and after targeted high-intensity resistance training.

Description:

Hip fracture is a major public health concern in the United States. Fall-related injuries constitute the leading cause of deaths and disabilities among persons over age 65 years. Hip fracture is consistently identified as one of the most frequent, costly, and devastating non-lethal injuries from a fall. Rehabilitation after hip fracture remains largely unchanged over the last 30 years despite evidence that high-intensity rehabilitation can benefit physical function after hip fracture beyond the recovery typical with "usual care".

Asymmetries demonstrated in physical performance of various tasks, such as gait, balance, and a sit-to-stand transfer, and impaired surgical limb muscle function are evident for years after hip fracture, and may contribute to the high rate of falls and declining function typically encountered by older adults recovering from hip fracture. Implementing a high-intensity rehabilitation approach targeting asymmetries after hip fracture is likely to yield improved symmetry in both physical function and muscle function. This study will recruit older adults who have recently incurred a hip fracture and completed "usual care" physical therapy to determine whether a high-intensity rehabilitation strategy targeting asymmetries in movement strategies and muscle function of the surgical limb can be successfully implemented in this challenging population. In particular, recruitment, adherence to rehab protocol parameters, and retention will be addressed among those who initiate high-resistance training at approximately 8-12wk after hip fracture incidence.

In addition, the investigators will explore the potential of targeted unilaterally-biased resistance training to improve surgical limb function and performance after hip fracture. Specifically, physical performance, muscle function, and muscle quality/composition are recorded and compared pre-/post-training to determine whether improvements occur in conjunction with high-intensity rehabilitation training. Additionally, the investigators will measure improvements in muscle composition that occur as a result of this high-intensity resistance training.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Age greater than 50 yrs

• Ability to sign informed consent

• Mental Status MoCA score greater than 22

• Independent community ambulatory prior to hip fracture

• Ability to ambulate greater than 50 feet with or without assistive device

Exclusion Criteria:

• Previous hip fracture

• Bilateral hip fracture

• Pathological fracture

• Expected life Expectancy less than one year

• Permanently institutionalized

• Fracture result of multi-trauma

• Cardiac abnormalities

• Neuromuscular impairments

• Unstable medical conditions

• Elevated systolic greater than 150 or diastolic blood pressure greater than 100

• Implanted electronic devices

• History of stroke with motor disability

• Alcohol or drug abuse

• Respiratory disease

• Conditions deemed exclusionary by PI or physician

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Behavioral:
• Unilaterally Biased Resistance Training / "MOVE"
High-intensity resistance training including: whole body movement patterns, unilaterally biased lower extremity strength training, task-oriented balance tasks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Intermountain Health Care, Inc.

References & Publications (15)

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

D'Adamo CR, Hawkes WG, Miller RR, Jones M, Hochberg M, Yu-Yahiro J, Hebel JR, Magaziner J. Short-term changes in body composition after surgical repair of hip fracture. Age Ageing. 2014 Mar;43(2):275-80. doi: 10.1093/ageing/aft198. Epub 2013 Dec 25. — View Citation

Edgren J, Rantanen T, Heinonen A, Portegijs E, Alén M, Kiviranta I, Kallinen M, Sipilä S. Effects of progressive resistance training on physical disability among older community-dwelling people with history of hip fracture. Aging Clin Exp Res. 2012 Apr;24(2):171-5. — View Citation

Edgren J, Salpakoski A, Rantanen T, Heinonen A, Kallinen M, von Bonsdorff MB, Portegijs E, Sihvonen S, Sipilä S. Balance confidence and functional balance are associated with physical disability after hip fracture. Gait Posture. 2013 Feb;37(2):201-5. doi: 10.1016/j.gaitpost.2012.07.001. Epub 2012 Aug 9. — View Citation

Fox KM, Magaziner J, Hawkes WG, Yu-Yahiro J, Hebel JR, Zimmerman SI, Holder L, Michael R. Loss of bone density and lean body mass after hip fracture. Osteoporos Int. 2000;11(1):31-5. — View Citation

Host HH, Sinacore DR, Bohnert KL, Steger-May K, Brown M, Binder EF. Training-induced strength and functional adaptations after hip fracture. Phys Ther. 2007 Mar;87(3):292-303. Epub 2007 Feb 6. — View Citation

Houck J, Kneiss J, Bukata SV, Puzas JE. Analysis of vertical ground reaction force variables during a Sit to Stand task in participants recovering from a hip fracture. Clin Biomech (Bristol, Avon). 2011 Jun;26(5):470-6. doi: 10.1016/j.clinbiomech.2010.12.004. Epub 2010 Dec 31. — View Citation

Kneiss JA, Hilton TN, Tome J, Houck JR. Weight-bearing asymmetry in individuals post-hip fracture during the sit to stand task. Clin Biomech (Bristol, Avon). 2015 Jan;30(1):14-21. doi: 10.1016/j.clinbiomech.2014.11.012. Epub 2014 Nov 29. — View Citation

Kneiss JA, Houck JR, Bukata SV, Puzas JE. Influence of upper extremity assistance on lower extremity force application symmetry in individuals post-hip fracture during the sit-to-stand task. J Orthop Sports Phys Ther. 2012 May;42(5):474-81. doi: 10.2519/jospt.2012.3562. Epub 2012 Apr 30. — 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

Miller RR, Eastlack M, Hicks GE, Alley DE, Shardell MD, Orwig DL, Goodpaster BH, Chomentowski PJ, Hawkes WG, Hochberg MC, Ferrucci L, Magaziner J. Asymmetry in CT Scan Measures of Thigh Muscle 2 Months After Hip Fracture: The Baltimore Hip Studies. J Gerontol A Biol Sci Med Sci. 2015 Jun;70(6):753-6. doi: 10.1093/gerona/glr188. — View Citation

Penrod JD, Boockvar KS, Litke A, Magaziner J, Hannan EL, Halm EA, Silberzweig SB, Sean Morrison R, Orosz GM, Koval KJ, Siu AL. Physical therapy and mobility 2 and 6 months after hip fracture. J Am Geriatr Soc. 2004 Jul;52(7):1114-20. — View Citation

Portegijs E, Kallinen M, Rantanen T, Heinonen A, Sihvonen S, Alen M, Kiviranta I, Sipilä S. Effects of resistance training on lower-extremity impairments in older people with hip fracture. Arch Phys Med Rehabil. 2008 Sep;89(9):1667-74. doi: 10.1016/j.apmr.2008.01.026. — View Citation

Portegijs E, Sipilä S, Rantanen T, Lamb SE. Leg extension power deficit and mobility limitation in women recovering from hip fracture. Am J Phys Med Rehabil. 2008 May;87(5):363-70. doi: 10.1097/PHM.0b013e318164a9e2. — View Citation

Visser M, Harris TB, Fox KM, Hawkes W, Hebel JR, Yahiro JY, Michael R, Zimmerman SI, Magaziner J. Change in muscle mass and muscle strength after a hip fracture: relationship to mobility recovery. J Gerontol A Biol Sci Med Sci. 2000 Aug;55(8):M434-40. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	muscle quality	muscle quality (force/unit area) calculated by using force and mass variables	12 week	No
Primary	muscle strength	Knee extension muscle strength was measured on an isokinetic dynamometer as a maximum voluntary isometric contraction in newtons (N) of force. The average of three trials was used.	12 week	No
Primary	muscle power	Leg extension muscle power was measured on a Nottingham power rig in watts (W). The average of three trials was used.	12 week	No
Secondary	sit-to-stand task performance	biomechanics (vGRF) measured during sit-to-stand task performance	12 week	No
Secondary	usual gait speed	Gait speed was measured at usual speed over a 50 foot distance and reported in meters/second.	12 week	No
Secondary	muscle mass	MRI analysis of quadriceps muscle mass reported as average cross-sectional area in cm2.	12 week	No
Secondary	Modified Physical Performance Test	The modified physical performance test (mPPT) is a standardized nine-item test designed to assess multiple dimensions of physical function was used to assess overall physical function. Scores are reported on a scale from 0-36.	12 week	No
Secondary	Berg Balance Scale	The Berg Balance Scale (BBS) is a 14-item objective scale that provides a reliable and valid measure of static balance, with scores less than 45 indicating significant fall risk among older adults. Scores range from 0-56.	12 week	No
Secondary	Timed up and Go Test	The Timed up and go test is recorded as the time in seconds to stand, walk 3 meters, turn around and return to a chair. The average time of three trials is reported.	12 week	No
Secondary	Stair Climb Test	The time taken to ascend 10 stairs is reported.	12 week	No
Secondary	Stair Descent Test	The time taken to descend 10 stairs is reported.	12 week	No
Secondary	Lower Extremity Measure	The Lower Extremity Measure (LEM) is a 29-item self-report questionnaire that is reliable, valid, and responsive to improvement, with scores of 75 indicating moderate frailty, and scores above 85 indicating normal mobility and physical function after hip fracture. Scores range from 0-100.	12 week	No
Secondary	Activities Specific Balance Scale	Activities-Specific Balance Confidence (ABC) scale is a 16-item, validated, reliable, self-report scale used to determine balance confidence. Scores range from 0-100.	12 week	No
Secondary	Six minute walk test	The distance in meters (m) walked in six minutes is recorded.	12 week.	No