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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04709783
Other study ID # IRB202001011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 26, 2022
Est. completion date June 5, 2023

Study information

Verified date July 2023
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 aims include to evaluate the implementation outcomes and clinical outcomes, and to identify facilitators and barriers associated with the implementation.


Description:

Medicare beneficiaries admitted to home health agencies are often in a 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 therapists and occupational therapists 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 aims include to evaluate the implementation outcomes and clinical outcomes, and to identify facilitators and barriers associated with the implementation.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date June 5, 2023
Est. primary completion date April 3, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
3-Step Workout for Life
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.

Locations

Country Name City State
United States University of Florida Gainesville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida American Occupational Therapy Foundation

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Self-care items from the Outcome and Assessment Information Set (OASIS) 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
Secondary Mobility items from the Outcome and Assessment Information Set (OASIS) 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
Secondary EuroQoL (EQ-5D-5L) 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. Change from admission to discharge which is a period of about two months
Secondary Activity Measure Post Acute Care (AM-PAC): Home Care Short Form 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. Change from admission to discharge which is a period of about two months
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