Frail Elderly, Homebound Persons
Conditions
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
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.
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
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Selected Walking Speed | From baseline to 60 days post-baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed-Up-And-Go Test | Baseline | 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. |
| Short Physical Performance Battery (SPPB) | Baseline | 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. |
| Modified Physical Performance Test (mPPT) | Baseline | 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. |
| Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor | Baseline | 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. |
| Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor | Baseline | 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. |
| Grip Strength: Dominant Hand | Baseline | 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). |
| Self-Selected Walking Speed | Baseline | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Life-Space Assessment Survey | Baseline | 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. |
| The Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS) | Baseline | 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. |
| The Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS) | Baseline | 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. |
| St. Louis University Mental Status Examination (SLUMS) | Baseline | 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. |
| Step Count | Baseline | 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. |
| Patient Activation Measure Survey (PAM) | Baseline | 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). |
Countries
United States
Participant flow
Pre-assignment details
90 post-consent screen failures
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 7 | 2 |
| Overall Study | Lost to Follow-up | 4 | 7 |
| Overall Study | Withdrawal by Subject | 5 | 12 |
Baseline characteristics
| Characteristic | Usual Care (UC) | Progressive High Intensity Therapy | Total |
|---|---|---|---|
| Age, Continuous | 76.0 Years | 77.0 Years | 76.5 Years |
| Education Associate's | 10 Participants | 8 Participants | 18 Participants |
| Education Bachelor's/Master's/Doctoral | 21 Participants | 15 Participants | 36 Participants |
| Education High School Diploma | 17 Participants | 23 Participants | 40 Participants |
| Education Less Than High School | 5 Participants | 3 Participants | 8 Participants |
| Education Some College | 21 Participants | 26 Participants | 47 Participants |
| Education Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 14 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants | 59 Participants | 122 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 2 Participants | 7 Participants |
| Marital Status Divorced/Separated | 18 Participants | 16 Participants | 34 Participants |
| Marital Status Married/Cohabitating | 29 Participants | 33 Participants | 62 Participants |
| Marital Status Single | 6 Participants | 9 Participants | 15 Participants |
| Marital Status Unknown or Not Reported | 9 Participants | 1 Participants | 10 Participants |
| Marital Status Widowed | 13 Participants | 16 Participants | 29 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 18 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) White | 58 Participants | 50 Participants | 108 Participants |
| Region of Enrollment United States | 75 Participants | 75 Participants | 150 Participants |
| Sex: Female, Male Female | 6 Participants | 17 Participants | 23 Participants |
| Sex: Female, Male Male | 69 Participants | 58 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 75 | 2 / 75 |
| other Total, other adverse events | 46 / 75 | 47 / 75 |
| serious Total, serious adverse events | 33 / 75 | 34 / 75 |
Outcome results
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care (UC) | Change in Self-Selected Walking Speed | 0.08 m/s |
| Progressive High Intensity Therapy | Change in Self-Selected Walking Speed | 0.08 m/s |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Grip Strength: Dominant Hand | 24.60 kg | Standard Deviation 8.98 |
| Progressive High Intensity Therapy | Grip Strength: Dominant Hand | 27.94 kg | Standard Deviation 13.1 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Grip Strength: Dominant Hand | 26.15 kg | Standard Deviation 8.03 |
| Progressive High Intensity Therapy | Grip Strength: Dominant Hand | 27.86 kg | Standard Deviation 10.98 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Grip Strength: Dominant Hand | 26.13 kg | Standard Deviation 7.22 |
| Progressive High Intensity Therapy | Grip Strength: Dominant Hand | 27.35 kg | Standard Deviation 11.75 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Grip Strength: Dominant Hand | 26.57 kg | Standard Deviation 8.7 |
| Progressive High Intensity Therapy | Grip Strength: Dominant Hand | 25.81 kg | Standard Deviation 10.77 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Grip Strength: Dominant Hand | 26.06 kg | Standard Deviation 9.34 |
| Progressive High Intensity Therapy | Grip Strength: Dominant Hand | 26.21 kg | Standard Deviation 11.31 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor | 18.17 kg | Standard Deviation 6.28 |
| Progressive High Intensity Therapy | Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor | 19.80 kg | Standard Deviation 10.28 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor | 19.86 kg | Standard Deviation 6.57 |
| Progressive High Intensity Therapy | Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor | 19.52 kg | Standard Deviation 7.91 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor | 17.74 kg | Standard Deviation 6.72 |
| Progressive High Intensity Therapy | Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor | 18.93 kg | Standard Deviation 6.55 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor | 20.52 kg | Standard Deviation 8.29 |
| Progressive High Intensity Therapy | Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor | 18.13 kg | Standard Deviation 7.16 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor | 18.64 kg | Standard Deviation 8.23 |
| Progressive High Intensity Therapy | Lower Extremity Strength Via Hand-Held Dynamometry: Left Knee Extensor | 18.73 kg | Standard Deviation 10.54 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor | 19.24 kg | Standard Deviation 7.57 |
| Progressive High Intensity Therapy | Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor | 19.34 kg | Standard Deviation 5.13 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor | 19.03 kg | Standard Deviation 9.32 |
| Progressive High Intensity Therapy | Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor | 18.08 kg | Standard Deviation 9.1 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor | 18.67 kg | Standard Deviation 6.12 |
| Progressive High Intensity Therapy | Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor | 19.09 kg | Standard Deviation 10.07 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor | 21.11 kg | Standard Deviation 9.04 |
| Progressive High Intensity Therapy | Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor | 18.61 kg | Standard Deviation 6.8 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor | 20.99 kg | Standard Deviation 7.76 |
| Progressive High Intensity Therapy | Lower Extremity Strength Via Hand-Held Dynamometry: Right Knee Extensor | 19.37 kg | Standard Deviation 7.18 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Modified Physical Performance Test (mPPT) | 15.49 score on a scale | Standard Deviation 7.77 |
| Progressive High Intensity Therapy | Modified Physical Performance Test (mPPT) | 16.51 score on a scale | Standard Deviation 7.07 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Modified Physical Performance Test (mPPT) | 12.31 score on a scale | Standard Deviation 6.57 |
| Progressive High Intensity Therapy | Modified Physical Performance Test (mPPT) | 12.08 score on a scale | Standard Deviation 6.29 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Modified Physical Performance Test (mPPT) | 16.47 score on a scale | Standard Deviation 7.43 |
| Progressive High Intensity Therapy | Modified Physical Performance Test (mPPT) | 15.37 score on a scale | Standard Deviation 6.88 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Modified Physical Performance Test (mPPT) | 16.04 score on a scale | Standard Deviation 7.6 |
| Progressive High Intensity Therapy | Modified Physical Performance Test (mPPT) | 15.38 score on a scale | Standard Deviation 6.61 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Modified Physical Performance Test (mPPT) | 15.63 score on a scale | Standard Deviation 7.32 |
| Progressive High Intensity Therapy | Modified Physical Performance Test (mPPT) | 15.07 score on a scale | Standard Deviation 7.4 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Self-Selected Walking Speed | 0.59 m/s | Standard Deviation 0.2 |
| Progressive High Intensity Therapy | Self-Selected Walking Speed | 0.57 m/s | Standard Deviation 0.22 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Self-Selected Walking Speed | 0.49 m/s | Standard Deviation 0.19 |
| Progressive High Intensity Therapy | Self-Selected Walking Speed | 0.50 m/s | Standard Deviation 0.17 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Self-Selected Walking Speed | 0.61 m/s | Standard Deviation 0.22 |
| Progressive High Intensity Therapy | Self-Selected Walking Speed | 0.60 m/s | Standard Deviation 0.27 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Self-Selected Walking Speed | 0.63 m/s | Standard Deviation 0.24 |
| Progressive High Intensity Therapy | Self-Selected Walking Speed | 0.60 m/s | Standard Deviation 0.23 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Short Physical Performance Battery (SPPB) | 6.46 score on a scale | Standard Deviation 3.13 |
| Progressive High Intensity Therapy | Short Physical Performance Battery (SPPB) | 6.22 score on a scale | Standard Deviation 2.86 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Short Physical Performance Battery (SPPB) | 5.07 score on a scale | Standard Deviation 2.5 |
| Progressive High Intensity Therapy | Short Physical Performance Battery (SPPB) | 5.27 score on a scale | Standard Deviation 2.54 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Short Physical Performance Battery (SPPB) | 6.82 score on a scale | Standard Deviation 3.3 |
| Progressive High Intensity Therapy | Short Physical Performance Battery (SPPB) | 6.46 score on a scale | Standard Deviation 3.16 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Short Physical Performance Battery (SPPB) | 6.43 score on a scale | Standard Deviation 3.27 |
| Progressive High Intensity Therapy | Short Physical Performance Battery (SPPB) | 5.97 score on a scale | Standard Deviation 3.05 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Short Physical Performance Battery (SPPB) | 6.50 score on a scale | Standard Deviation 3.3 |
| Progressive High Intensity Therapy | Short Physical Performance Battery (SPPB) | 6.11 score on a scale | Standard Deviation 3.15 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Timed-Up-And-Go Test | 16.15 seconds | Standard Deviation 9.67 |
| Progressive High Intensity Therapy | Timed-Up-And-Go Test | 16.15 seconds | Standard Deviation 7.61 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Timed-Up-And-Go Test | 22.91 seconds | Standard Deviation 18.74 |
| Progressive High Intensity Therapy | Timed-Up-And-Go Test | 19.98 seconds | Standard Deviation 11.81 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Timed-Up-And-Go Test | 15.96 seconds | Standard Deviation 8.26 |
| Progressive High Intensity Therapy | Timed-Up-And-Go Test | 16.61 seconds | Standard Deviation 9.73 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Timed-Up-And-Go Test | 18.80 seconds | Standard Deviation 3.27 |
| Progressive High Intensity Therapy | Timed-Up-And-Go Test | 17.78 seconds | Standard Deviation 14.14 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Timed-Up-And-Go Test | 18.47 seconds | Standard Deviation 15.32 |
| Progressive High Intensity Therapy | Timed-Up-And-Go Test | 17.21 seconds | Standard Deviation 9.56 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Patient Activation Measure Survey (PAM) | 60.82 score on a scale | Standard Deviation 13.04 |
| Progressive High Intensity Therapy | Patient Activation Measure Survey (PAM) | 62.13 score on a scale | Standard Deviation 14.04 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Step Count | 2298.56 steps per day | Standard Deviation 1774.04 |
| Progressive High Intensity Therapy | Step Count | 2190.65 steps per day | Standard Deviation 1367.09 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Step Count | 3098.33 steps per day | Standard Deviation 2125.86 |
| Progressive High Intensity Therapy | Step Count | 2724.17 steps per day | Standard Deviation 1675.4 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Step Count | 2410.59 steps per day | Standard Deviation 1737.08 |
| Progressive High Intensity Therapy | Step Count | 2583.33 steps per day | Standard Deviation 1403.92 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | St. Louis University Mental Status Examination (SLUMS) | 23.86 score on a scale | Standard Deviation 4.4 |
| Progressive High Intensity Therapy | St. Louis University Mental Status Examination (SLUMS) | 22.59 score on a scale | Standard Deviation 5.01 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | St. Louis University Mental Status Examination (SLUMS) | 22.68 score on a scale | Standard Deviation 4.14 |
| Progressive High Intensity Therapy | St. Louis University Mental Status Examination (SLUMS) | 22.28 score on a scale | Standard Deviation 4.3 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | St. Louis University Mental Status Examination (SLUMS) | 23.17 score on a scale | Standard Deviation 4.78 |
| Progressive High Intensity Therapy | St. Louis University Mental Status Examination (SLUMS) | 22.49 score on a scale | Standard Deviation 4.78 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | The Life-Space Assessment Survey | 41.57 score on a scale | Standard Deviation 16.7 |
| Progressive High Intensity Therapy | The Life-Space Assessment Survey | 40.54 score on a scale | Standard Deviation 17.61 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | The Life-Space Assessment Survey | 42.62 score on a scale | Standard Deviation 20.4 |
| Progressive High Intensity Therapy | The Life-Space Assessment Survey | 40.17 score on a scale | Standard Deviation 39 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | The Life-Space Assessment Survey | 34.01 score on a scale | Standard Deviation 16.43 |
| Progressive High Intensity Therapy | The Life-Space Assessment Survey | 32.13 score on a scale | Standard Deviation 16.69 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | The Life-Space Assessment Survey | 39.79 score on a scale | Standard Deviation 15.75 |
| Progressive High Intensity Therapy | The Life-Space Assessment Survey | 39.71 score on a scale | Standard Deviation 15.91 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | The Life-Space Assessment Survey | 40.92 score on a scale | Standard Deviation 41.56 |
| Progressive High Intensity Therapy | The Life-Space Assessment Survey | 38.71 score on a scale | Standard Deviation 19.99 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | The Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS) | 45.83 score on a scale | Standard Deviation 12.34 |
| Progressive High Intensity Therapy | The Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS) | 45.03 score on a scale | Standard Deviation 12.94 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | The Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS) | 48.83 score on a scale | Standard Deviation 12.91 |
| Progressive High Intensity Therapy | The Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS) | 45.30 score on a scale | Standard Deviation 15.04 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | The Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS) | 50.70 score on a scale | Standard Deviation 11.53 |
| Progressive High Intensity Therapy | The Veterans Rand 12 Items Health Survey (VR-12): Mental Component Score (MCS) | 44.13 score on a scale | Standard Deviation 12.36 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | The Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS) | 29.34 score on a scale | Standard Deviation 8.64 |
| Progressive High Intensity Therapy | The Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS) | 28.82 score on a scale | Standard Deviation 9.29 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | The Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS) | 32.94 score on a scale | Standard Deviation 10.28 |
| Progressive High Intensity Therapy | The Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS) | 32.41 score on a scale | Standard Deviation 11.58 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | The Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS) | 33.77 score on a scale | Standard Deviation 10.8 |
| Progressive High Intensity Therapy | The Veterans Rand 12 Items Health Survey (VR-12): Physical Component Score (PCS) | 32.55 score on a scale | Standard Deviation 10.6 |