Trial Outcomes & Findings for Implementing 3-Step Workout for Life in Home Health (NCT NCT04709783)

Last Updated: 2025-01-03

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

Discharge, on average 2 months

Results posted on

2025-01-03

Participant Flow

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.

Of 10 enrolled patients, all received the modified 3-Step Workout for Life program.

Participant milestones

Participant milestones
Measure	Implementation Arm Participants received the modified 3-Step Workout for Life program and other rehabilitation services based on the plan of care. 3-Step Workout for Life: Participants received the 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 training. During the resistance exercise sessions, participants will use resistance tubing to strengthen major muscle groups of the upper extremity and 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, participants may also receive other routine rehabilitation treatment determined and provided by their therapists to facilitate their functional recovery.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Implementing 3-Step Workout for Life in Home Health

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Implementation Arm n=10 Participants Participants will receive the modified 3-Step Workout for Life program and other rehabilitation services based on the plan of care. 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.
Age, Continuous	76.8 Years STANDARD_DEVIATION 6.94 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Ratio OASIS (Outcome and Assessment Information Set): Self-care and mobility Self-care	.65 Ratio STANDARD_DEVIATION .08 • n=5 Participants
Ratio OASIS (Outcome and Assessment Information Set): Self-care and mobility Mobility	.63 Ratio STANDARD_DEVIATION .1 • n=5 Participants
Activity Measure of Post-Acute Care-Home Health Version Basic Mobility Domain	50.15 T-scale score STANDARD_DEVIATION 6.52 • n=5 Participants
Activity Measure of Post-Acute Care-Home Health Version Daily Activity Domain	49.53 T-scale score STANDARD_DEVIATION 9.35 • n=5 Participants
Activity Measure of Post-Acute Care-Home Health Version Applied Cognitive Domain	44.35 T-scale score STANDARD_DEVIATION 6.92 • n=5 Participants
European Quality of Life 5 Dimensions EQ-5D-5L	.49 units on a scale STANDARD_DEVIATION .27 • n=5 Participants
European Quality of Life 5 Dimensions EQ-VA	57 units on a scale STANDARD_DEVIATION 29.08 • n=5 Participants

PRIMARY outcome

Timeframe: Discharge, on average 2 months

Outcome measures

Outcome measures
Measure	Implementation Arm n=9 Participants Participants will receive the modified 3-Step Workout for Life program and other rehabilitation services based on the plan of care. 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	0.93 Ratio Standard Deviation 0.14

SECONDARY outcome

Timeframe: Discharge, on average 2 months

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.

Outcome measures

Outcome measures
Measure	Implementation Arm n=9 Participants Participants will receive the modified 3-Step Workout for Life program and other rehabilitation services based on the plan of care. 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: Mobility	0.89 Ratio Standard Deviation 0.19

SECONDARY outcome

Timeframe: Discharge, on average 2 months

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.

Outcome measures

Outcome measures
Measure	Implementation Arm n=10 Participants Participants will receive the modified 3-Step Workout for Life program and other rehabilitation services based on the plan of care. 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.
EuroQoL (European Quality of Life) EQ-5D-5L	0.68 score on a scale Standard Deviation .22
EuroQoL (European Quality of Life) EQ-VAS	64.5 score on a scale Standard Deviation 22.29

SECONDARY outcome

Timeframe: Discharge, on average 2 months

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.

Outcome measures

Outcome measures
Measure	Implementation Arm n=10 Participants Participants will receive the modified 3-Step Workout for Life program and other rehabilitation services based on the plan of care. 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.
Activity Measure of Post-Acute Care-Home Health Version Basic Mobility Domain	55.77 T-scale score Standard Deviation 7.64
Activity Measure of Post-Acute Care-Home Health Version Daily Activity Domain	54.96 T-scale score Standard Deviation 7.22
Activity Measure of Post-Acute Care-Home Health Version Applied Cognitive Domain	45.44 T-scale score Standard Deviation 5.98

Adverse Events

Implementation Arm

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Implementation Arm n=10 participants at risk Participants will receive the 3-Step Workout for Life program and other rehabilitation services based on the plan of care. 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.
Musculoskeletal and connective tissue disorders Anticipated adverse event	60.0% 6/10 • Number of events 6 • Two months The study therapy staff will check and record the adverse events of each patient and document the events. An "adverse event" is any untoward medical occurrence in a patient, not necessarily have a causal relationship with the study. A "serious adverse event" is any untoward medical occurrence that: a) results in death, b) is life-threatening, c) requires hospitalization or prolongation of existing hospitalization, or d) results in persistent or significant disability or incapacity.
Musculoskeletal and connective tissue disorders Fall	10.0% 1/10 • Number of events 1 • Two months The study therapy staff will check and record the adverse events of each patient and document the events. An "adverse event" is any untoward medical occurrence in a patient, not necessarily have a causal relationship with the study. A "serious adverse event" is any untoward medical occurrence that: a) results in death, b) is life-threatening, c) requires hospitalization or prolongation of existing hospitalization, or d) results in persistent or significant disability or incapacity.

Additional Information

Chiung-ju (CJ) Liu

University of Florida

Phone: 352-273-6496

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place