- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04709783
Implementing 3-Step Workout for Life in Home Health
Implementing 3-Step Workout for Life to Improve ADL Outcome in Home Health
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- University of Florida
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- is a Medicare beneficiary
- admitted to the partnered home health agency
- show or experience muscle weakness
- demonstrate functional limitation on at least one of the OASIS self-care items
Exclusion Criteria:
- has an acute fracture with surgical or weight-bearing restrictions
- has elective joint replacement surgery
- has a lower extremity amputation
- is receiving active treatment for cancer diagnosis
- has on-going dialysis treatment
- had acute cardiac surgery
- with acute stroke or neurologic disorder that limits motor movements
- in terminal stages of congestive heart failure
- has been referred to hospice care
- has severe cognitive deficits limiting verbal communication
- has significant medical complications that preclude safe participation in resistance exercise
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Implementation Arm
Participants will receive the 3-Step Workout for Life program and other rehabilitation services based on the plan of care.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ratio OASIS (Outcome and Assessment Information Set) Items: Self-care
Time Frame: Discharge, on average 2 months
|
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.
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Discharge, on average 2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ratio OASIS (Outcome and Assessment Information Set) Items: Mobility
Time Frame: 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.
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Discharge, on average 2 months
|
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EuroQoL (European Quality of Life)
Time Frame: Discharge, on average 2 months
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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. |
Discharge, on average 2 months
|
|
Activity Measure of Post-Acute Care-Home Health Version
Time Frame: Discharge, on average 2 months
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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.
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Discharge, on average 2 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chiung-ju Liu, PhD, University of Florida
Publications and helpful links
General Publications
- Liu CJ, Jones LY, Formyduval A RM, Clark DO. Task-Oriented Exercise to Reduce Activities of Daily Living Disability in Vulnerable Older Adults: A Feasibility Study of the 3-Step Workout for Life. J Aging Phys Act. 2016 Jul;24(3):384-92. doi: 10.1123/japa.2015-0070. Epub 2015 Nov 19.
- Liu CJ, Xu H, Keith NR, Clark DO. Promoting ADL independence in vulnerable, community-dwelling older adults: a pilot RCT comparing 3-Step Workout for Life versus resistance exercise. Clin Interv Aging. 2017 Jul 19;12:1141-1149. doi: 10.2147/CIA.S136678. eCollection 2017.
- Liu CJ, Donovan J, Wolford CL. Feasibility of staff-led 3-Step Workout for Life to reduce late-life activities of daily living disability: a community-based translational study. Int J Rehabil Res. 2020 Jun;43(2):141-147. doi: 10.1097/MRR.0000000000000396.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202001011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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