- 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 Contact
- Name: Chiung-ju Liu, PhD
- Phone Number: 352-273-6496
- Email: c.liu1@phhp.ufl.edu
Study Locations
-
-
Florida
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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 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-care items from the Outcome and Assessment Information Set (OASIS)
Time Frame: Change from admission to discharge which is a period of about two months
|
The self-care items are selected from the OASIS.
OASIS is a comprehensive assessment to collect information in home health Medicare patients.
The self-care items evaluate the degree of independence in seven activities: eating, oral hygiene, toileting hygiene, upper body dressing, lower body dressing, shower/bathe, and putting on/removing footwear.
Each activity is scored on a six-point Likert scale ranging from 1 (totally dependent) to 6 (totally independent).
The home health care provider scores the patient based on information obtained from observation and interview.
If an activity was not attempted, the reason would be documented (for example, the patient refused, not applicable because the patient did not perform this activity prior to the current illness, not attempted due to environmental limitations, medication conditions, or safety concerns).
A ratio score will be computed to adjust for items that are not attempted.
|
Change from admission to discharge which is a period of about two months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mobility items from the Outcome and Assessment Information Set (OASIS)
Time Frame: Change from admission to discharge which is a period of about two months
|
The mobility items are selected from the OASIS. The mobility items evaluate the degree of independence in the following activities: roll left and right, sit to lying, lying to sitting on side of the bed, sit to stand, chair/bed-to-chair transfer, toilet transfer, car transfer, walk 10 feet, walk 50 feet with two turns, walk 150 feet, walking 10 feet on uneven surfaces, 1 step (curb), 4 steps, 12 steps, picking up an object from the floor, wheel (use a wheelchair or scooter) 50 feet with two turns, & wheel 150 feet. Each activity is scored on a six-point Likert scale ranging from 1 (totally dependent) to 6 (totally independent). The home health care provider scores the patient based on information obtained from observation and interview. If an activity was not attempted, the reason would be documented. A ratio score will be computed to adjust for items that are not attempted. |
Change from admission to discharge which is a period of about two months
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EuroQoL (EQ-5D-5L)
Time Frame: Change from admission to discharge which is a period of about two months
|
EuroQoL is a self-reported, health-related, quality of life questionnaire.
It measures the quality of life on 5 domains, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each domain is rated on a 5-level scale, with a higher level indicates a better outcome.
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Change from admission to discharge which is a period of about two months
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Activity Measure Post Acute Care (AM-PAC): Home Care Short Form
Time Frame: Change from admission to discharge which is a period of about two months
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AM-PAC home care short form is a patient-report outcome measure.
It assesses patients' degree of difficulty doing daily activities, basic mobility, and functional cognition tasks (e.g., remember to take medications).
A higher level indicates a better outcome.
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Change from admission to discharge which is a period of about two 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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