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Improving Function in Older Veterans With Hospital-Associated Deconditioning

Improving Function in Older Veterans With Hospital-associated Deconditioning

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02696382
Enrollment
240
Registered
2016-03-02
Start date
2016-04-01
Completion date
2021-10-08
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frail Elderly, Homebound Persons

Keywords

Veterans, Progressive High Intensity Physical Therapy, Gait Speed, Acute Hospitalization, Hospital Associated Deconditioning

Brief 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.

Detailed 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.

Interventions

BEHAVIORALProgressive 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.

BEHAVIORALUsual 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.

Sponsors

University of Colorado, Denver
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Self-Selected Walking SpeedFrom baseline to 60 days post-baselineWill 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).

Secondary

MeasureTime frameDescription
Timed-Up-And-Go TestBaselineThe 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.
Short Physical Performance Battery (SPPB)BaselineThe 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.
Modified Physical Performance Test (mPPT)BaselinemPPT 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.
Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee ExtensorBaselineQuadriceps 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.
Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee ExtensorBaselineQuadriceps 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.
Grip Strength: Dominant HandBaselineGrip 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).
Self-Selected Walking SpeedBaselineWill 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).

Other

MeasureTime frameDescription
The Life-Space Assessment SurveyBaselineThe 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.
The Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS)BaselineThe 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.
The Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS)BaselineThe 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.
St. Louis University Mental Status Examination (SLUMS)BaselineSLUMS 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.
Step CountBaselineMounted, 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.
Patient Activation Measure Survey (PAM)BaselineA 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).

Countries

United States

Participant flow

Pre-assignment details

90 post-consent screen failures

Participants by arm

ArmCount
Usual Care (UC)
Participants in the Usual Care (UC) group received standard, low-intensity physical therapy following discharge from acute hospitalization. Usual Care (UC): Participants in the Usual Care group received standard physical therapy following discharge from acute hospitalization. The activities of therapy included basic strength training, single-planar motor control and gait exercises, and activities of daily living training. Participants received 12 intervention visits over 4 weeks (3 visits per week). Participants also received a standardized home exercise program.
75
Progressive High Intensity Therapy
Participants in the Progressive High Intensity Therapy (PHIT) group received high intensity physical therapy following discharge from acute hospitalization. Progressive High Intensity Therapy (PHIT): Participants in the Progressive High Intensity Therapy (PHIT) group received high intensity physical therapy following discharge from acute hospitalization. The activities of training included 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 received 12 intervention visits over 4 weeks (3 visits per week). Participants also received a standardized home exercise program.
75
Total150

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath72
Overall StudyLost to Follow-up47
Overall StudyWithdrawal by Subject512

Baseline characteristics

CharacteristicUsual Care (UC)Progressive High Intensity TherapyTotal
Age, Continuous76.0 Years77.0 Years76.5 Years
Education
Associate's
10 Participants8 Participants18 Participants
Education
Bachelor's/Master's/Doctoral
21 Participants15 Participants36 Participants
Education
High School Diploma
17 Participants23 Participants40 Participants
Education
Less Than High School
5 Participants3 Participants8 Participants
Education
Some College
21 Participants26 Participants47 Participants
Education
Unknown or Not Reported
1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants14 Participants21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
63 Participants59 Participants122 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants2 Participants7 Participants
Marital Status
Divorced/Separated
18 Participants16 Participants34 Participants
Marital Status
Married/Cohabitating
29 Participants33 Participants62 Participants
Marital Status
Single
6 Participants9 Participants15 Participants
Marital Status
Unknown or Not Reported
9 Participants1 Participants10 Participants
Marital Status
Widowed
13 Participants16 Participants29 Participants
Race (NIH/OMB)
American Indian or Alaska Native
4 Participants2 Participants6 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
10 Participants18 Participants28 Participants
Race (NIH/OMB)
More than one race
2 Participants2 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants3 Participants4 Participants
Race (NIH/OMB)
White
58 Participants50 Participants108 Participants
Region of Enrollment
United States
75 Participants75 Participants150 Participants
Sex: Female, Male
Female
6 Participants17 Participants23 Participants
Sex: Female, Male
Male
69 Participants58 Participants127 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
7 / 752 / 75
other
Total, other adverse events
46 / 7547 / 75
serious
Total, serious adverse events
33 / 7534 / 75

Outcome results

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).

Time frame: From baseline to 60 days post-baseline

ArmMeasureValue (MEAN)
Usual Care (UC)Change in Self-Selected Walking Speed0.08 m/s
Progressive High Intensity TherapyChange in Self-Selected Walking Speed0.08 m/s
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).

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Grip Strength: Dominant Hand24.60 kgStandard Deviation 8.98
Progressive High Intensity TherapyGrip Strength: Dominant Hand27.94 kgStandard Deviation 13.1
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).

Time frame: 180 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Grip Strength: Dominant Hand26.15 kgStandard Deviation 8.03
Progressive High Intensity TherapyGrip Strength: Dominant Hand27.86 kgStandard Deviation 10.98
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).

Time frame: 90 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Grip Strength: Dominant Hand26.13 kgStandard Deviation 7.22
Progressive High Intensity TherapyGrip Strength: Dominant Hand27.35 kgStandard Deviation 11.75
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).

Time frame: 60 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Grip Strength: Dominant Hand26.57 kgStandard Deviation 8.7
Progressive High Intensity TherapyGrip Strength: Dominant Hand25.81 kgStandard Deviation 10.77
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).

Time frame: 30 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Grip Strength: Dominant Hand26.06 kgStandard Deviation 9.34
Progressive High Intensity TherapyGrip Strength: Dominant Hand26.21 kgStandard Deviation 11.31
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.

Time frame: 30 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor18.17 kgStandard Deviation 6.28
Progressive High Intensity TherapyLower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor19.80 kgStandard Deviation 10.28
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.

Time frame: 180 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor19.86 kgStandard Deviation 6.57
Progressive High Intensity TherapyLower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor19.52 kgStandard Deviation 7.91
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.

Time frame: 90 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor17.74 kgStandard Deviation 6.72
Progressive High Intensity TherapyLower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor18.93 kgStandard Deviation 6.55
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.

Time frame: 60 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor20.52 kgStandard Deviation 8.29
Progressive High Intensity TherapyLower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor18.13 kgStandard Deviation 7.16
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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor18.64 kgStandard Deviation 8.23
Progressive High Intensity TherapyLower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor18.73 kgStandard Deviation 10.54
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.

Time frame: 90 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor19.24 kgStandard Deviation 7.57
Progressive High Intensity TherapyLower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor19.34 kgStandard Deviation 5.13
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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor19.03 kgStandard Deviation 9.32
Progressive High Intensity TherapyLower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor18.08 kgStandard Deviation 9.1
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.

Time frame: 30 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor18.67 kgStandard Deviation 6.12
Progressive High Intensity TherapyLower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor19.09 kgStandard Deviation 10.07
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.

Time frame: 60 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor21.11 kgStandard Deviation 9.04
Progressive High Intensity TherapyLower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor18.61 kgStandard Deviation 6.8
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.

Time frame: 180 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor20.99 kgStandard Deviation 7.76
Progressive High Intensity TherapyLower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor19.37 kgStandard Deviation 7.18
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.

Time frame: 180 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Modified Physical Performance Test (mPPT)15.49 score on a scaleStandard Deviation 7.77
Progressive High Intensity TherapyModified Physical Performance Test (mPPT)16.51 score on a scaleStandard Deviation 7.07
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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Modified Physical Performance Test (mPPT)12.31 score on a scaleStandard Deviation 6.57
Progressive High Intensity TherapyModified Physical Performance Test (mPPT)12.08 score on a scaleStandard Deviation 6.29
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.

Time frame: 30 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Modified Physical Performance Test (mPPT)16.47 score on a scaleStandard Deviation 7.43
Progressive High Intensity TherapyModified Physical Performance Test (mPPT)15.37 score on a scaleStandard Deviation 6.88
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.

Time frame: 60 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Modified Physical Performance Test (mPPT)16.04 score on a scaleStandard Deviation 7.6
Progressive High Intensity TherapyModified Physical Performance Test (mPPT)15.38 score on a scaleStandard Deviation 6.61
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.

Time frame: 90 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Modified Physical Performance Test (mPPT)15.63 score on a scaleStandard Deviation 7.32
Progressive High Intensity TherapyModified Physical Performance Test (mPPT)15.07 score on a scaleStandard Deviation 7.4
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).

Time frame: 30 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Self-Selected Walking Speed0.59 m/sStandard Deviation 0.2
Progressive High Intensity TherapySelf-Selected Walking Speed0.57 m/sStandard Deviation 0.22
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).

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Self-Selected Walking Speed0.49 m/sStandard Deviation 0.19
Progressive High Intensity TherapySelf-Selected Walking Speed0.50 m/sStandard Deviation 0.17
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).

Time frame: 90 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Self-Selected Walking Speed0.61 m/sStandard Deviation 0.22
Progressive High Intensity TherapySelf-Selected Walking Speed0.60 m/sStandard Deviation 0.27
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).

Time frame: 180 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Self-Selected Walking Speed0.63 m/sStandard Deviation 0.24
Progressive High Intensity TherapySelf-Selected Walking Speed0.60 m/sStandard Deviation 0.23
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.

Time frame: 30 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Short Physical Performance Battery (SPPB)6.46 score on a scaleStandard Deviation 3.13
Progressive High Intensity TherapyShort Physical Performance Battery (SPPB)6.22 score on a scaleStandard Deviation 2.86
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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Short Physical Performance Battery (SPPB)5.07 score on a scaleStandard Deviation 2.5
Progressive High Intensity TherapyShort Physical Performance Battery (SPPB)5.27 score on a scaleStandard Deviation 2.54
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.

Time frame: 180 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Short Physical Performance Battery (SPPB)6.82 score on a scaleStandard Deviation 3.3
Progressive High Intensity TherapyShort Physical Performance Battery (SPPB)6.46 score on a scaleStandard Deviation 3.16
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.

Time frame: 90 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Short Physical Performance Battery (SPPB)6.43 score on a scaleStandard Deviation 3.27
Progressive High Intensity TherapyShort Physical Performance Battery (SPPB)5.97 score on a scaleStandard Deviation 3.05
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.

Time frame: 60 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Short Physical Performance Battery (SPPB)6.50 score on a scaleStandard Deviation 3.3
Progressive High Intensity TherapyShort Physical Performance Battery (SPPB)6.11 score on a scaleStandard Deviation 3.15
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.

Time frame: 30 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Timed-Up-And-Go Test16.15 secondsStandard Deviation 9.67
Progressive High Intensity TherapyTimed-Up-And-Go Test16.15 secondsStandard Deviation 7.61
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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Timed-Up-And-Go Test22.91 secondsStandard Deviation 18.74
Progressive High Intensity TherapyTimed-Up-And-Go Test19.98 secondsStandard Deviation 11.81
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.

Time frame: 180 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Timed-Up-And-Go Test15.96 secondsStandard Deviation 8.26
Progressive High Intensity TherapyTimed-Up-And-Go Test16.61 secondsStandard Deviation 9.73
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.

Time frame: 90 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Timed-Up-And-Go Test18.80 secondsStandard Deviation 3.27
Progressive High Intensity TherapyTimed-Up-And-Go Test17.78 secondsStandard Deviation 14.14
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.

Time frame: 60 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Timed-Up-And-Go Test18.47 secondsStandard Deviation 15.32
Progressive High Intensity TherapyTimed-Up-And-Go Test17.21 secondsStandard Deviation 9.56
Other Pre-specified

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).

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Patient Activation Measure Survey (PAM)60.82 score on a scaleStandard Deviation 13.04
Progressive High Intensity TherapyPatient Activation Measure Survey (PAM)62.13 score on a scaleStandard Deviation 14.04
Other Pre-specified

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.

Time frame: Baseline

Population: Activity monitor placement was deferred for those participants who declined placement, demonstrated impaired skin integrity, or were unable to understand instructions.

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Step Count2298.56 steps per dayStandard Deviation 1774.04
Progressive High Intensity TherapyStep Count2190.65 steps per dayStandard Deviation 1367.09
Other Pre-specified

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.

Time frame: 60 Days

Population: Activity monitor placement was deferred for those participants who declined placement, demonstrated impaired skin integrity, or were unable to understand instructions.

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Step Count3098.33 steps per dayStandard Deviation 2125.86
Progressive High Intensity TherapyStep Count2724.17 steps per dayStandard Deviation 1675.4
Other Pre-specified

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.

Time frame: 180 Days

Population: Activity monitor placement was deferred for those participants who declined placement, demonstrated impaired skin integrity, or were unable to understand instructions.

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)Step Count2410.59 steps per dayStandard Deviation 1737.08
Progressive High Intensity TherapyStep Count2583.33 steps per dayStandard Deviation 1403.92
Other Pre-specified

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.

Time frame: 180 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)St. Louis University Mental Status Examination (SLUMS)23.86 score on a scaleStandard Deviation 4.4
Progressive High Intensity TherapySt. Louis University Mental Status Examination (SLUMS)22.59 score on a scaleStandard Deviation 5.01
Other Pre-specified

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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)St. Louis University Mental Status Examination (SLUMS)22.68 score on a scaleStandard Deviation 4.14
Progressive High Intensity TherapySt. Louis University Mental Status Examination (SLUMS)22.28 score on a scaleStandard Deviation 4.3
Other Pre-specified

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.

Time frame: 60 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)St. Louis University Mental Status Examination (SLUMS)23.17 score on a scaleStandard Deviation 4.78
Progressive High Intensity TherapySt. Louis University Mental Status Examination (SLUMS)22.49 score on a scaleStandard Deviation 4.78
Other Pre-specified

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.

Time frame: 90 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)The Life-Space Assessment Survey41.57 score on a scaleStandard Deviation 16.7
Progressive High Intensity TherapyThe Life-Space Assessment Survey40.54 score on a scaleStandard Deviation 17.61
Other Pre-specified

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.

Time frame: 180 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)The Life-Space Assessment Survey42.62 score on a scaleStandard Deviation 20.4
Progressive High Intensity TherapyThe Life-Space Assessment Survey40.17 score on a scaleStandard Deviation 39
Other Pre-specified

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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)The Life-Space Assessment Survey34.01 score on a scaleStandard Deviation 16.43
Progressive High Intensity TherapyThe Life-Space Assessment Survey32.13 score on a scaleStandard Deviation 16.69
Other Pre-specified

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.

Time frame: 30 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)The Life-Space Assessment Survey39.79 score on a scaleStandard Deviation 15.75
Progressive High Intensity TherapyThe Life-Space Assessment Survey39.71 score on a scaleStandard Deviation 15.91
Other Pre-specified

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.

Time frame: 60 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)The Life-Space Assessment Survey40.92 score on a scaleStandard Deviation 41.56
Progressive High Intensity TherapyThe Life-Space Assessment Survey38.71 score on a scaleStandard Deviation 19.99
Other Pre-specified

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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)The Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS)45.83 score on a scaleStandard Deviation 12.34
Progressive High Intensity TherapyThe Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS)45.03 score on a scaleStandard Deviation 12.94
Other Pre-specified

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.

Time frame: 60 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)The Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS)48.83 score on a scaleStandard Deviation 12.91
Progressive High Intensity TherapyThe Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS)45.30 score on a scaleStandard Deviation 15.04
Other Pre-specified

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.

Time frame: 180 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)The Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS)50.70 score on a scaleStandard Deviation 11.53
Progressive High Intensity TherapyThe Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS)44.13 score on a scaleStandard Deviation 12.36
Other Pre-specified

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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)The Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS)29.34 score on a scaleStandard Deviation 8.64
Progressive High Intensity TherapyThe Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS)28.82 score on a scaleStandard Deviation 9.29
Other Pre-specified

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.

Time frame: 60 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)The Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS)32.94 score on a scaleStandard Deviation 10.28
Progressive High Intensity TherapyThe Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS)32.41 score on a scaleStandard Deviation 11.58
Other Pre-specified

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.

Time frame: 180 Days

ArmMeasureValue (MEAN)Dispersion
Usual Care (UC)The Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS)33.77 score on a scaleStandard Deviation 10.8
Progressive High Intensity TherapyThe Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS)32.55 score on a scaleStandard Deviation 10.6

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026