Improving Function in Older Veterans With Hospital-Associated Deconditioning

Frail Elderly Clinical Trial

Official title:

Improving Function in Older Veterans With Hospital-associated Deconditioning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696382
• Other study ID #: E1978-R
• Secondary ID: 15-1571
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: October 8, 2021

Study information

• Verified date: September 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators plan to test an innovative, home-based, short duration, high intensity exercise program designed for application in the immediate post-hospitalization period in older Veterans. Preliminary data suggest a more intensive approach to physical therapy in older adults after hospitalization is safe and maximizes mobility more than usual care. The Veterans participating in the high intensity exercise program will receive therapy utilizing higher resistance exercises. Outcomes from this group will be compared to data collected from the patients receiving standard, lower resistance therapies.

Description:

Hospital associated deconditioning is a common and profound contributor to functional decline in older adults. Skeletal muscle weakness and atrophy are commonly observed in older adults with deconditioning after a hospitalizations, leading to chronic functional deficits. This is especially concerning for elderly Veterans, a population who tends to suffer from more chronic conditions and have decreased physical function than the general older adult population. Therefore, Veterans may be at even higher risk for developing disability in activities of daily living after hospitalization and be homebound. Home health physical therapy may be the ideal venue for addressing this functional decline as around 3 million older adults receive home health services following hospital discharge. These services, however, tend to be low intensity and do not appear to adequately address deficits in function or performance of home and community mobility. To address these concerns, the investigators have developed and tested an innovative, short-duration, home-based, high intensity exercise program designed for application immediately following hospitalization. This protocol will dose twelve therapy visits over the course of 30 days to determine whether visit frontloading has any effect on outcomes. The investigators are using a series of high resistance therapy exercises following acute hospitalization to determine if progressive high intensity therapy sustainability improves physical function more than standard home health physical therapy after an acute hospitalization in older Veterans. Outcomes will spotlight physical function, community mobility, Activities of Daily Living, quality of life, and cognition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 8, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 99 Years

Eligibility

Inclusion Criteria:

• Recent hospitalization or period of deconditioning

• Veteran Status

• Referred to or eligible for home health physical therapy

• Have at least 3 comorbid conditions including: Chronic Obstructive Pulmonary Disease (COPD), pneumonia, hypertension, hernia, heart disease, spinal stenosis, atrial fibrillation, post-op bowel surgery, gastrointestinal bleed, chronic ulcerative wounds, depression/ mental health, post-op pancreatic surgery, hypercholesterolemia, dehydration, hypo/hyperthyroid, congestive heart failure, urinary tract infection, diabetes, irritable bowel syndrome, osteoporosis, osteoarthritis, rheumatoid arthritis, gout, peripheral artery disease, syncope, renal failure-no dialysis

• Be ambulatory without human assistance prior to hospitalization

Exclusion Criteria:

• Acute lower extremity fracture with weight-bearing restriction

• Elective joint replacement surgery

• Lower extremity amputation

• Acute cardiac surgery

• Terminal illness

• Cancer

• Alzheimer's disease

• Deep vein thrombosis

• Recent stroke

• Degenerative neurological conditions

• Gait speed slower than 0.3 m/s or >1.0 meters/second

• Inability to walk 10 feet without human assistance --History of illegal substance use

Related Conditions & MeSH terms

• Frail Elderly
• Homebound Persons

Intervention

Behavioral:
• Progressive High Intensity Therapy (PHIT)
Participants in the "Progressive High Intensity Therapy" (PHIT) group will receive high intensity physical therapy following discharge from acute hospitalization. The activities of training will include progressive resistance training, multi-planar motor control and gait exercises, and high intensity activities of daily living training. Like the Usual Care group, the PHIT participants will receive 12 intervention visits over 4 weeks (3 visits per week). Participants will also receive a standardized home exercise program.
• Usual Care (UC)
Participants in the "Usual Care" group will receive standard physical therapy following discharge from acute hospitalization. The activities of therapy will include basic strength training, single-planar motor control and gait exercises, and activities of daily living training. Participants will receive 12 intervention visits over 4 weeks (3 visits per week). Participants will also receive a standardized home exercise program.

Locations

Country	Name	City	State
United States	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (5)

Andersen LL, Andersen CH, Mortensen OS, Poulsen OM, Bjornlund IB, Zebis MK. Muscle activation and perceived loading during rehabilitation exercises: comparison of dumbbells and elastic resistance. Phys Ther. 2010 Apr;90(4):538-49. doi: 10.2522/ptj.20090167. Epub 2010 Feb 4. — View Citation

El Solh A, Pineda L, Bouquin P, Mankowski C. Determinants of short and long term functional recovery after hospitalization for community-acquired pneumonia in the elderly: role of inflammatory markers. BMC Geriatr. 2006 Aug 9;6:12. doi: 10.1186/1471-2318-6-12. — View Citation

Falvey JR, Mangione KK, Stevens-Lapsley JE. Rethinking Hospital-Associated Deconditioning: Proposed Paradigm Shift. Phys Ther. 2015 Sep;95(9):1307-15. doi: 10.2522/ptj.20140511. Epub 2015 Apr 23. — View Citation

Mangione KK, Lopopolo RB, Neff NP, Craik RL, Palombaro KM. Interventions used by physical therapists in home care for people after hip fracture. Phys Ther. 2008 Feb;88(2):199-210. doi: 10.2522/ptj.20070023. Epub 2007 Dec 4. — View Citation

Tinetti ME, Baker D, Gallo WT, Nanda A, Charpentier P, O'Leary J. Evaluation of restorative care vs usual care for older adults receiving an acute episode of home care. JAMA. 2002 Apr 24;287(16):2098-105. doi: 10.1001/jama.287.16.2098. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Activation Measure Survey (PAM)	A self-administered, validated survey identifying patient motivation levels regarding their healthcare. The PAM survey can reliably predict ER visits, hospital admissions, and medication/ therapy adherence. The final score is a composite score of the available 13 items, ranging from 0-100, wherein a higher score indicates a higher activation (better outcomes).	Baseline
Other	Step Count	Mounted, tri-axial accelerometer activPAL (PAL Technologies Ltd, Glasgow, UK) was used to capture steps. The activPAL was mounted following completion of the associated assessment and was set to record physical activity for a 24-hour/day, 10-day wear protocol. Data was analyzed with the CREA algorithm (PAL Technologies Ltd) to determine valid wear days. Average step count across valid wear days was used for analysis.	Baseline
Other	Step Count	Mounted, tri-axial accelerometer activPAL (PAL Technologies Ltd, Glasgow, UK) was used to capture steps. The activPAL was mounted following completion of the associated assessment and was set to record physical activity for a 24-hour/day, 10-day wear protocol. Data was analyzed with the CREA algorithm (PAL Technologies Ltd) to determine valid wear days. Average step count across valid wear days was used for analysis.	60 Days
Other	Step Count	Mounted, tri-axial accelerometer activPAL (PAL Technologies Ltd, Glasgow, UK) was used to capture steps. The activPAL was mounted following completion of the associated assessment and was set to record physical activity for a 24-hour/day, 10-day wear protocol. Data was analyzed with the CREA algorithm (PAL Technologies Ltd) to determine valid wear days. Average step count across valid wear days was used for analysis.	180 Days
Other	The Life-Space Assessment Survey	The Life-Space Assessment survey is a self-reported measure assessing a patient's movement, extending from within the home to beyond a patient's town or geographic region during the prior 4 weeks. The composite score (summed) ranges from 0 to 120, with higher scores representing greater mobility.	Baseline
Other	The Life-Space Assessment Survey	The Life-Space Assessment survey is a self-reported measure assessing a patient's movement, extending from within the home to beyond a patient's town or geographic region during the prior 4 weeks. The composite score (summed) ranges from 0 to 120, with higher scores representing greater mobility.	30 Days
Other	The Life-Space Assessment Survey	The Life-Space Assessment survey is a self-reported measure assessing a patient's movement, extending from within the home to beyond a patient's town or geographic region during the prior 4 weeks. The composite score (summed) ranges from 0 to 120, with higher scores representing greater mobility.	60 Days
Other	The Life-Space Assessment Survey	The Life-Space Assessment survey is a self-reported measure assessing a patient's movement, extending from within the home to beyond a patient's town or geographic region during the prior 4 weeks. The composite score (summed) ranges from 0 to 120, with higher scores representing greater mobility.	90 Days
Other	The Life-Space Assessment Survey	The Life-Space Assessment survey is a self-reported measure assessing a patient's movement, extending from within the home to beyond a patient's town or geographic region during the prior 4 weeks. The composite score (summed) ranges from 0 to 120, with higher scores representing greater mobility.	180 Days
Other	The Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS)	The Veterans RAND 12 Item Health Survey (VR-12) is a patient-reported global health measure that is used to assess a patient's overall perspective of their health. The questions in this survey correspond to seven different health domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into two scores, a Physical Component Score (PCS) and a Mental Component Score (MCS) which then provides an important contrast between the respondents' physical and psychological health status. Each component score is summarized from 0 to 100, with a higher score indicating a better outcome.	Baseline
Other	The Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS)	The Veterans RAND 12 Item Health Survey (VR-12) is a patient-reported global health measure that is used to assess a patient's overall perspective of their health. The questions in this survey correspond to seven different health domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into two scores, a Physical Component Score (PCS) and a Mental Component Score (MCS) which then provides an important contrast between the respondents' physical and psychological health status. Each component score is summarized from 0 to 100, with a higher score indicating a better outcome.	60 Days
Other	The Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS)	The Veterans RAND 12 Item Health Survey (VR-12) is a patient-reported global health measure that is used to assess a patient's overall perspective of their health. The questions in this survey correspond to seven different health domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into two scores, a Physical Component Score (PCS) and a Mental Component Score (MCS) which then provides an important contrast between the respondents' physical and psychological health status. Each component score is summarized from 0 to 100, with a higher score indicating a better outcome.	180 Days
Other	The Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS)	The Veterans RAND 12 Item Health Survey (VR-12) is a patient-reported global health measure that is used to assess a patient's overall perspective of their health. The questions in this survey correspond to seven different health domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into two scores, a Physical Component Score (PCS) and a Mental Component Score (MCS) which then provides an important contrast between the respondents' physical and psychological health status. Each component score is summarized from 0 to 100, with a higher score indicating a better outcome.	Baseline
Other	The Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS)	The Veterans RAND 12 Item Health Survey (VR-12) is a patient-reported global health measure that is used to assess a patient's overall perspective of their health. The questions in this survey correspond to seven different health domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into two scores, a Physical Component Score (PCS) and a Mental Component Score (MCS) which then provides an important contrast between the respondents' physical and psychological health status. Each component score is summarized from 0 to 100, with a higher score indicating a better outcome.	60 Days
Other	The Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS)	The Veterans RAND 12 Item Health Survey (VR-12) is a patient-reported global health measure that is used to assess a patient's overall perspective of their health. The questions in this survey correspond to seven different health domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into two scores, a Physical Component Score (PCS) and a Mental Component Score (MCS) which then provides an important contrast between the respondents' physical and psychological health status. Each component score is summarized from 0 to 100, with a higher score indicating a better outcome.	180 Days
Other	St. Louis University Mental Status Examination (SLUMS)	SLUMS screens for cognitive impairments by assessing participant function in the areas of attention, calculation, immediate and delayed recall, animal naming, and visuospatial skills. Scores range from 0 to 30, wherein a higher score indicates less cognitive impairment. Scores of 27 to 30 are considered normal in a person with a high school education. Scores between 21 and 26 suggest a mild neurocognitive disorder. Scores between 0 and 20 indicate dementia.	Baseline
Other	St. Louis University Mental Status Examination (SLUMS)	SLUMS screens for cognitive impairments by assessing participant function in the areas of attention, calculation, immediate and delayed recall, animal naming, and visuospatial skills. Scores range from 0 to 30, wherein a higher score indicates less cognitive impairment. Scores of 27 to 30 are considered normal in a person with a high school education. Scores between 21 and 26 suggest a mild neurocognitive disorder. Scores between 0 and 20 indicate dementia.	60 Days
Other	St. Louis University Mental Status Examination (SLUMS)	SLUMS screens for cognitive impairments by assessing participant function in the areas of attention, calculation, immediate and delayed recall, animal naming, and visuospatial skills. Scores range from 0 to 30, wherein a higher score indicates less cognitive impairment. Scores of 27 to 30 are considered normal in a person with a high school education. Scores between 21 and 26 suggest a mild neurocognitive disorder. Scores between 0 and 20 indicate dementia.	180 Days
Primary	Change in Self-Selected Walking Speed	Will be assessed at the subject's self selected speed for each participant over 4 meters. Faster walking indicates capacity for performance of certain activities (e.g. crossing a street before the light changes).	From baseline to 60 days post-baseline
Secondary	Short Physical Performance Battery (SPPB)	The SPPB is a well-accepted global measure of lower extremity function which consists of a composite measure including walking speed, chair stands, and balance. It is a strong predictor of disability, institutionalization, and morbidity in older adults. The SPPB is comprised of 3 tasks: a hierarchical standing balance test (side-by-side, semi-tandem, and tandem), a 4-meter usual gait speed, and a 5-time sit-to-stand from a standardized chair. Each subtask is scored (based on time) from 0-4 points and then summarized into a total score of 0-12 points, where 12 points represents the highest performance.	Baseline
Secondary	Short Physical Performance Battery (SPPB)	The SPPB is a well-accepted global measure of lower extremity function which consists of a composite measure including walking speed, chair stands, and balance. It is a strong predictor of disability, institutionalization, and morbidity in older adults. The SPPB is comprised of 3 tasks: a hierarchical standing balance test (side-by-side, semi-tandem, and tandem), a 4-meter usual gait speed, and a 5-time sit-to-stand from a standardized chair. Each subtask is scored (based on time) from 0-4 points and then summarized into a total score of 0-12 points, where 12 points represents the highest performance.	30 Days
Secondary	Short Physical Performance Battery (SPPB)	The SPPB is a well-accepted global measure of lower extremity function which consists of a composite measure including walking speed, chair stands, and balance. It is a strong predictor of disability, institutionalization, and morbidity in older adults. The SPPB is comprised of 3 tasks: a hierarchical standing balance test (side-by-side, semi-tandem, and tandem), a 4-meter usual gait speed, and a 5-time sit-to-stand from a standardized chair. Each subtask is scored (based on time) from 0-4 points and then summarized into a total score of 0-12 points, where 12 points represents the highest performance.	60 Days
Secondary	Short Physical Performance Battery (SPPB)	The SPPB is a well-accepted global measure of lower extremity function which consists of a composite measure including walking speed, chair stands, and balance. It is a strong predictor of disability, institutionalization, and morbidity in older adults. The SPPB is comprised of 3 tasks: a hierarchical standing balance test (side-by-side, semi-tandem, and tandem), a 4-meter usual gait speed, and a 5-time sit-to-stand from a standardized chair. Each subtask is scored (based on time) from 0-4 points and then summarized into a total score of 0-12 points, where 12 points represents the highest performance.	90 Days
Secondary	Short Physical Performance Battery (SPPB)	The SPPB is a well-accepted global measure of lower extremity function which consists of a composite measure including walking speed, chair stands, and balance. It is a strong predictor of disability, institutionalization, and morbidity in older adults. The SPPB is comprised of 3 tasks: a hierarchical standing balance test (side-by-side, semi-tandem, and tandem), a 4-meter usual gait speed, and a 5-time sit-to-stand from a standardized chair. Each subtask is scored (based on time) from 0-4 points and then summarized into a total score of 0-12 points, where 12 points represents the highest performance.	180 Days
Secondary	Timed-Up-And-Go Test	The TUG measures the time it takes a patient to rise from an arm chair (seat height of 46 cm), walk 3 m, turn and return to sitting in the same chair without physical assistance. This test has excellent inter-rater (ICC=0.99) and intra-rater reliability (ICC=0.99), as measured in a group of 60 functionally disabled older adults (mean age 80 years). Faster times indicate a better outcome.	Baseline
Secondary	Timed-Up-And-Go Test	The TUG measures the time it takes a patient to rise from an arm chair (seat height of 46 cm), walk 3 m, turn and return to sitting in the same chair without physical assistance. This test has excellent inter-rater (ICC=0.99) and intra-rater reliability (ICC=0.99), as measured in a group of 60 functionally disabled older adults (mean age 80 years). Faster times indicate a better outcome.	30 Days
Secondary	Timed-Up-And-Go Test	The TUG measures the time it takes a patient to rise from an arm chair (seat height of 46 cm), walk 3 m, turn and return to sitting in the same chair without physical assistance. This test has excellent inter-rater (ICC=0.99) and intra-rater reliability (ICC=0.99), as measured in a group of 60 functionally disabled older adults (mean age 80 years). Faster times indicate a better outcome.	60 Days
Secondary	Timed-Up-And-Go Test	The TUG measures the time it takes a patient to rise from an arm chair (seat height of 46 cm), walk 3 m, turn and return to sitting in the same chair without physical assistance. This test has excellent inter-rater (ICC=0.99) and intra-rater reliability (ICC=0.99), as measured in a group of 60 functionally disabled older adults (mean age 80 years). Faster times indicate a better outcome.	90 Days
Secondary	Timed-Up-And-Go Test	The TUG measures the time it takes a patient to rise from an arm chair (seat height of 46 cm), walk 3 m, turn and return to sitting in the same chair without physical assistance. This test has excellent inter-rater (ICC=0.99) and intra-rater reliability (ICC=0.99), as measured in a group of 60 functionally disabled older adults (mean age 80 years). Faster times indicate a better outcome.	180 Days
Secondary	Modified Physical Performance Test (mPPT)	mPPT assesses 7 tasks. Based on the time it takes to complete each task, a score from 0 (unable to complete) to 4 (performed quickly and easily) is given for each item. The maximal score is 28 and includes tasks that involve upper and lower extremity function. Test-retest reliability for the modified PPT score is 0.96. The instrument is sensitive to change and has been used in exercise trials with frail elders.	Baseline
Secondary	Modified Physical Performance Test (mPPT)	mPPT assesses 7 tasks. Based on the time it takes to complete each task, a score from 0 (unable to complete) to 4 (performed quickly and easily) is given for each item. The maximal score is 28 and includes tasks that involve upper and lower extremity function. Test-retest reliability for the modified PPT score is 0.96. The instrument is sensitive to change and has been used in exercise trials with frail elders.	30 Days
Secondary	Modified Physical Performance Test (mPPT)	mPPT assesses 7 tasks. Based on the time it takes to complete each task, a score from 0 (unable to complete) to 4 (performed quickly and easily) is given for each item. The maximal score is 28 and includes tasks that involve upper and lower extremity function. Test-retest reliability for the modified PPT score is 0.96. The instrument is sensitive to change and has been used in exercise trials with frail elders.	60 Days
Secondary	Modified Physical Performance Test (mPPT)	mPPT assesses 7 tasks. Based on the time it takes to complete each task, a score from 0 (unable to complete) to 4 (performed quickly and easily) is given for each item. The maximal score is 28 and includes tasks that involve upper and lower extremity function. Test-retest reliability for the modified PPT score is 0.96. The instrument is sensitive to change and has been used in exercise trials with frail elders.	90 Days
Secondary	Modified Physical Performance Test (mPPT)	mPPT assesses 7 tasks. Based on the time it takes to complete each task, a score from 0 (unable to complete) to 4 (performed quickly and easily) is given for each item. The maximal score is 28 and includes tasks that involve upper and lower extremity function. Test-retest reliability for the modified PPT score is 0.96. The instrument is sensitive to change and has been used in exercise trials with frail elders.	180 Days
Secondary	Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor	Quadriceps muscle strength was tested via hand-held dynamometry (Lafayette Instrument Company, Lafayette, IN), wherein higher numbers indicate greater strength (better outcome). Method established in previous work: The position of the dynamometer was held perpendicular to the limb segment toward which it was directed, and the plate of the dynamometer was placed in the same position on the tested limb each time. The tester manually stabilized the limb segment proximally and provided verbal and visual cues of the muscle contraction prior to the isometric test. Individuals were asked to maintain the maximum effort for 2-3 seconds, at which point the tester told them to stop. Strength for each muscle was tested until two maximal attempts were within 5% of each other, and the highest value, to the nearest tenth of a kg, was used in analysis.	Baseline
Secondary	Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor	Quadriceps muscle strength was tested via hand-held dynamometry (Lafayette Instrument Company, Lafayette, IN), wherein higher numbers indicate greater strength (better outcome). Method established in previous work: The position of the dynamometer was held perpendicular to the limb segment toward which it was directed, and the plate of the dynamometer was placed in the same position on the tested limb each time. The tester manually stabilized the limb segment proximally and provided verbal and visual cues of the muscle contraction prior to the isometric test. Individuals were asked to maintain the maximum effort for 2-3 seconds, at which point the tester told them to stop. Strength for each muscle was tested until two maximal attempts were within 5% of each other, and the highest value, to the nearest tenth of a kg, was used in analysis.	30 Days
Secondary	Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor	Quadriceps muscle strength was tested via hand-held dynamometry (Lafayette Instrument Company, Lafayette, IN), wherein higher numbers indicate greater strength (better outcome). Method established in previous work: The position of the dynamometer was held perpendicular to the limb segment toward which it was directed, and the plate of the dynamometer was placed in the same position on the tested limb each time. The tester manually stabilized the limb segment proximally and provided verbal and visual cues of the muscle contraction prior to the isometric test. Individuals were asked to maintain the maximum effort for 2-3 seconds, at which point the tester told them to stop. Strength for each muscle was tested until two maximal attempts were within 5% of each other, and the highest value, to the nearest tenth of a kg, was used in analysis.	60 Days
Secondary	Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor	Quadriceps muscle strength was tested via hand-held dynamometry (Lafayette Instrument Company, Lafayette, IN), wherein higher numbers indicate greater strength (better outcome). Method established in previous work: The position of the dynamometer was held perpendicular to the limb segment toward which it was directed, and the plate of the dynamometer was placed in the same position on the tested limb each time. The tester manually stabilized the limb segment proximally and provided verbal and visual cues of the muscle contraction prior to the isometric test. Individuals were asked to maintain the maximum effort for 2-3 seconds, at which point the tester told them to stop. Strength for each muscle was tested until two maximal attempts were within 5% of each other, and the highest value, to the nearest tenth of a kg, was used in analysis.	90 Days
Secondary	Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor	Quadriceps muscle strength was tested via hand-held dynamometry (Lafayette Instrument Company, Lafayette, IN), wherein higher numbers indicate greater strength (better outcome). Method established in previous work: The position of the dynamometer was held perpendicular to the limb segment toward which it was directed, and the plate of the dynamometer was placed in the same position on the tested limb each time. The tester manually stabilized the limb segment proximally and provided verbal and visual cues of the muscle contraction prior to the isometric test. Individuals were asked to maintain the maximum effort for 2-3 seconds, at which point the tester told them to stop. Strength for each muscle was tested until two maximal attempts were within 5% of each other, and the highest value, to the nearest tenth of a kg, was used in analysis.	180 Days
Secondary	Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor	Quadriceps muscle strength was tested via hand-held dynamometry (Lafayette Instrument Company, Lafayette, IN), wherein higher numbers indicate greater strength (better outcome). Method established in previous work: The position of the dynamometer was held perpendicular to the limb segment toward which it was directed, and the plate of the dynamometer was placed in the same position on the tested limb each time. The tester manually stabilized the limb segment proximally and provided verbal and visual cues of the muscle contraction prior to the isometric test. Individuals were asked to maintain the maximum effort for 2-3 seconds, at which point the tester told them to stop. Strength for each muscle was tested until two maximal attempts were within 5% of each other, and the highest value, to the nearest tenth of a kg, was used in analysis.	Baseline
Secondary	Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor	Quadriceps muscle strength was tested via hand-held dynamometry (Lafayette Instrument Company, Lafayette, IN), wherein higher numbers indicate greater strength (better outcome). Method established in previous work: The position of the dynamometer was held perpendicular to the limb segment toward which it was directed, and the plate of the dynamometer was placed in the same position on the tested limb each time. The tester manually stabilized the limb segment proximally and provided verbal and visual cues of the muscle contraction prior to the isometric test. Individuals were asked to maintain the maximum effort for 2-3 seconds, at which point the tester told them to stop. Strength for each muscle was tested until two maximal attempts were within 5% of each other, and the highest value, to the nearest tenth of a kg, was used in analysis.	30 Days
Secondary	Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor	Quadriceps muscle strength was tested via hand-held dynamometry (Lafayette Instrument Company, Lafayette, IN), wherein higher numbers indicate greater strength (better outcome). Method established in previous work: The position of the dynamometer was held perpendicular to the limb segment toward which it was directed, and the plate of the dynamometer was placed in the same position on the tested limb each time. The tester manually stabilized the limb segment proximally and provided verbal and visual cues of the muscle contraction prior to the isometric test. Individuals were asked to maintain the maximum effort for 2-3 seconds, at which point the tester told them to stop. Strength for each muscle was tested until two maximal attempts were within 5% of each other, and the highest value, to the nearest tenth of a kg, was used in analysis.	60 Days
Secondary	Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor	Quadriceps muscle strength was tested via hand-held dynamometry (Lafayette Instrument Company, Lafayette, IN), wherein higher numbers indicate greater strength (better outcome). Method established in previous work: The position of the dynamometer was held perpendicular to the limb segment toward which it was directed, and the plate of the dynamometer was placed in the same position on the tested limb each time. The tester manually stabilized the limb segment proximally and provided verbal and visual cues of the muscle contraction prior to the isometric test. Individuals were asked to maintain the maximum effort for 2-3 seconds, at which point the tester told them to stop. Strength for each muscle was tested until two maximal attempts were within 5% of each other, and the highest value, to the nearest tenth of a kg, was used in analysis.	90 Days
Secondary	Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor	Quadriceps muscle strength was tested via hand-held dynamometry (Lafayette Instrument Company, Lafayette, IN), wherein higher numbers indicate greater strength (better outcome). Method established in previous work: The position of the dynamometer was held perpendicular to the limb segment toward which it was directed, and the plate of the dynamometer was placed in the same position on the tested limb each time. The tester manually stabilized the limb segment proximally and provided verbal and visual cues of the muscle contraction prior to the isometric test. Individuals were asked to maintain the maximum effort for 2-3 seconds, at which point the tester told them to stop. Strength for each muscle was tested until two maximal attempts were within 5% of each other, and the highest value, to the nearest tenth of a kg, was used in analysis.	180 Days
Secondary	Grip Strength: Dominant Hand	Grip strength was measured on the dominant hand using a hand dynamometer with the participant seated and elbow positioned at 90 degrees of flexion with the arm resting against the trunk. Maximal grip strength during a 3 second hold was measured for at least 2 trials and a 3rd trial was allowed if differences between trials were > 5%. Higher numbers indicate greater strength (better outcome).	Baseline
Secondary	Grip Strength: Dominant Hand	Grip strength was measured on the dominant hand using a hand dynamometer with the participant seated and elbow positioned at 90 degrees of flexion with the arm resting against the trunk. Maximal grip strength during a 3 second hold was measured for at least 2 trials and a 3rd trial was allowed if differences between trials were > 5%. Higher numbers indicate greater strength (better outcome).	30 Days
Secondary	Grip Strength: Dominant Hand	Grip strength was measured on the dominant hand using a hand dynamometer with the participant seated and elbow positioned at 90 degrees of flexion with the arm resting against the trunk. Maximal grip strength during a 3 second hold was measured for at least 2 trials and a 3rd trial was allowed if differences between trials were > 5%. Higher numbers indicate greater strength (better outcome).	60 Days
Secondary	Grip Strength: Dominant Hand	Grip strength was measured on the dominant hand using a hand dynamometer with the participant seated and elbow positioned at 90 degrees of flexion with the arm resting against the trunk. Maximal grip strength during a 3 second hold was measured for at least 2 trials and a 3rd trial was allowed if differences between trials were > 5%. Higher numbers indicate greater strength (better outcome).	90 Days
Secondary	Grip Strength: Dominant Hand	Grip strength was measured on the dominant hand using a hand dynamometer with the participant seated and elbow positioned at 90 degrees of flexion with the arm resting against the trunk. Maximal grip strength during a 3 second hold was measured for at least 2 trials and a 3rd trial was allowed if differences between trials were > 5%. Higher numbers indicate greater strength (better outcome).	180 Days
Secondary	Self-Selected Walking Speed	Will be assessed at the subject's self selected speed for each participant over 4 meters. Faster walking indicates capacity for performance of certain activities (e.g. crossing a street before the light changes).	Baseline
Secondary	Self-Selected Walking Speed	Will be assessed at the subject's self selected speed for each participant over 4 meters. Faster walking indicates capacity for performance of certain activities (e.g. crossing a street before the light changes).	30 Days
Secondary	Self-Selected Walking Speed	Will be assessed at the subject's self selected speed for each participant over 4 meters. Faster walking indicates capacity for performance of certain activities (e.g. crossing a street before the light changes).	90 Days
Secondary	Self-Selected Walking Speed	Will be assessed at the subject's self selected speed for each participant over 4 meters. Faster walking indicates capacity for performance of certain activities (e.g. crossing a street before the light changes).	180 Days