An interventional study of 3-Step Workout for Life in Frailty and Disability or Chronic Disease Leading to Disablement, sponsored by University of Florida. Terminated at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-01-03.
Sponsored by University of Florida · Not applicable, Interventional, and Other
The purpose of this project is to study how to adapt and implement the 3-Step Workout for Life program in a local home health agency. A series of learning cycles will be conducted to adjust the treatment dose and delivery mode. The specific aim is to evaluate the implementation-related clinical and patient outcomes.
Medicare beneficiaries admitted to home health agencies are often in frail status with decreased muscle strength and difficulty in performing activities of daily living. The purpose of the proposed research is to study how to adapt and implement the 3-Step Workout for Life program by the physical therapy and occupational therapy practitioners in a local home health agency. A series of learning cycles will be conducted to adjust the treatment dose and delivery mode, so that the program can be implemented at low cost but remains effective in improving self-care ability for Medicare beneficiaries. The specific aim is to evaluate the implementation-related clinical and patient outcomes.
1,229 studies on the registry are indexed under Frailty; 433 are open to participants now.
This study's enrollment of 10 is below the median of 80 across 704 interventional studies indexed under Frailty.
Browse Frailty studies →University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.
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Exclusion Criteria:
Participants will receive the 3-Step Workout for Life program and other rehabilitation services based on the plan of care.
Other: 3-Step Workout for Life
Participants will receive the modified 3-step Workout for Life program given by their physical therapy or occupational therapy providers. The program includes single-joint and multiple joint progressive resistance exercise and activities of daily living exercise. During the resistance exercise sessions, participants will use resistance tubing to strengthen major muscle groups of the upper extremity and/or lower extremity. During the activities of daily living exercise, participants will practice activities of daily living that they experience difficulty. The intervention volume, duration, and frequency will be modified to enhance practicality in a home health care setting over the implementation phase. In addition to the 3-Step Workout for Life exercise, participants may also receive other routine rehabilitation treatment determined and provided by their therapists to facilitate their functional recovery.
Ratio OASIS (Outcome and Assessment Information Set) Items: Self-care
The self-care measure is from the OASIS. It evaluates the degree of independence in seven activities: eating, oral hygiene, toileting hygiene, upper body dressing, lower body dressing, showering/bathing, and putting on/removing footwear. Each activity is scored on a six-point Likert scale ranging from 1 (totally dependent) to 6 (totally independent). A ratio score is calculated as the sum of attempted activity scores divided by the maximal total score of attempted activities. For example, if the participant is dependent on all six self-care activities, the ratio score of this participant is 0.17 (= 7\*1/7\*6). The ratio score of OASIS self-care ranges from 0.17 (totally dependent on all self-care activities) to 1 (totally independent of all self-care activities). A higher ratio score means a higher ability to perform self-care.
Time frame: Discharge, on average 2 months
Ratio OASIS (Outcome and Assessment Information Set) Items: Mobility
The mobility measure from OASIS evaluates the degree of independence in 17 mobility activities, such as roll left and right or sit to lying. Each activity is scored on a six-point Likert scale ranging from 1 (totally dependent) to 6 (totally independent). A ratio score is calculated as the sum of attempted activity scores divided by the maximal total score of attempted activities. For example, if the participant is dependent on all 17 mobility activities, the ratio score of this participant is 0.17= 0.06 (17\*1/17\*6). The ratio score of OASIS mobility ranges from 0.17 (totally dependent on all mobility activities) to 1 (totally independent of all mobility activities). A higher ratio score means a higher ability to perform mobility tasks independently.
Time frame: Discharge, on average 2 months
EuroQoL (European Quality of Life)
EuroQoL is a self-reported quality of life measure. The EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) evaluates health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. An index score ranges from -0.59 (worst health) to 1 (best health). The EQ VAS (EuroQol\_visual analogue scale) records the patient's self-rated health on a vertical visual analog scale ranging from 0 to 100. A higher score indicates better self-perceived health status.
Time frame: Discharge, on average 2 months
Activity Measure of Post-Acute Care-Home Health Version
The measure evaluates the degree of difficulty in performing tasks in three domains: basic mobility, daily activities, and cognitive tasks. The raw score under each domain is then converted to a standardized T-scale score. According to the testing manual, the T-scale score range for basic mobility is from 30.36 to 70.71, for daily activities is from 22.45 to 61.92, and for applied cognition is from 9.89 to 49.40. A higher score indicates a better mobility, daily activities, or functional cognition performance. The manual does not provide information on clinically relevant thresholds or mean/SD of the T-scale.
Time frame: Discharge, on average 2 months
Participants were recruited from two offices of a local home health agency. The home health therapy staff screened and referred eligible home health patients between April 2022 and March 2023. The first eligible participant was enrolled on May 26, 2022, and the last was enrolled in February 2023.
| Milestone | Implementation Arm |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
The self-care measure is from the OASIS. It evaluates the degree of independence in seven activities: eating, oral hygiene, toileting hygiene, upper body dressing, lower body dressing, showering/bathing, and putting on/removing footwear. Each activity is scored on a six-point Likert scale ranging from 1 (totally dependent) to 6 (totally independent). A ratio score is calculated as the sum of attempted activity scores divided by the maximal total score of attempted activities. For example, if the participant is dependent on all six self-care activities, the ratio score of this participant is 0.17 (= 7\*1/7\*6). The ratio score of OASIS self-care ranges from 0.17 (totally dependent on all self-care activities) to 1 (totally independent of all self-care activities). A higher ratio score means a higher ability to perform self-care.
| Ratio | Implementation Arm |
|---|---|
| Ratio OASIS (Outcome and Assessment Information Set) Items: Self-care | 0.93 ± 0.14 |
The mobility measure from OASIS evaluates the degree of independence in 17 mobility activities, such as roll left and right or sit to lying. Each activity is scored on a six-point Likert scale ranging from 1 (totally dependent) to 6 (totally independent). A ratio score is calculated as the sum of attempted activity scores divided by the maximal total score of attempted activities. For example, if the participant is dependent on all 17 mobility activities, the ratio score of this participant is 0.17= 0.06 (17\*1/17\*6). The ratio score of OASIS mobility ranges from 0.17 (totally dependent on all mobility activities) to 1 (totally independent of all mobility activities). A higher ratio score means a higher ability to perform mobility tasks independently.
| Ratio | Implementation Arm |
|---|---|
| Ratio OASIS (Outcome and Assessment Information Set) Items: Mobility | 0.89 ± 0.19 |
EuroQoL is a self-reported quality of life measure. The EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) evaluates health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. An index score ranges from -0.59 (worst health) to 1 (best health). The EQ VAS (EuroQol\_visual analogue scale) records the patient's self-rated health on a vertical visual analog scale ranging from 0 to 100. A higher score indicates better self-perceived health status.
| score on a scale | Implementation Arm |
|---|---|
| EQ-5D-5L | 0.68 ± .22 |
| EQ-VAS | 64.5 ± 22.29 |
The measure evaluates the degree of difficulty in performing tasks in three domains: basic mobility, daily activities, and cognitive tasks. The raw score under each domain is then converted to a standardized T-scale score. According to the testing manual, the T-scale score range for basic mobility is from 30.36 to 70.71, for daily activities is from 22.45 to 61.92, and for applied cognition is from 9.89 to 49.40. A higher score indicates a better mobility, daily activities, or functional cognition performance. The manual does not provide information on clinically relevant thresholds or mean/SD of the T-scale.
| T-scale score | Implementation Arm |
|---|---|
| Basic Mobility Domain | 55.77 ± 7.64 |
| Daily Activity Domain | 54.96 ± 7.22 |
| Applied Cognitive Domain | 45.44 ± 5.98 |
Collected over Two months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Implementation Arm | 0/10 (0%) | 0/10 (0%) | 6/10 (60%) |
| Event | Implementation Arm |
|---|---|
| Anticipated adverse eventMusculoskeletal and connective tissue disorders | 6/10 |
| FallMusculoskeletal and connective tissue disorders | 1/10 |
| Age, Continuous(Years) | Implementation Arm |
|---|---|
| Mean | 76.8 ± 6.94 |
| Sex: Female, Male(Participants) | Implementation Arm |
|---|---|
| Female | 7 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Implementation Arm |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Implementation Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Ratio OASIS (Outcome and Assessment Information Set): Self-care and mobility(Ratio) | Implementation Arm |
|---|---|
| Self-care | .65 ± .08 |
| Mobility | .63 ± .1 |
| Activity Measure of Post-Acute Care-Home Health Version(T-scale score) | Implementation Arm |
|---|---|
| Basic Mobility Domain | 50.15 ± 6.52 |
| Daily Activity Domain | 49.53 ± 9.35 |
| Applied Cognitive Domain | 44.35 ± 6.92 |
| European Quality of Life 5 Dimensions(units on a scale) | Implementation Arm |
|---|---|
| EQ-5D-5L | .49 ± .27 |
| EQ-VA | 57 ± 29.08 |
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Plan to share: No
Ran from May 2022 to primary completion in Apr 2023, 10 months.
Results were first posted in Jan 2025, 1 year 9 months after primary completion.
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