Implementing 3-Step Workout for Life in Home Health

NCT ID: NCT04709783

Last Updated: 2025-01-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-26

Study Completion Date

2023-06-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Frailty Disability or Chronic Disease Leading to Disablement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Implementation Arm

Participants will receive the 3-Step Workout for Life program and other rehabilitation services based on the plan of care.

Group Type EXPERIMENTAL

3-Step Workout for Life

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

American Occupational Therapy Foundation

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chiung-ju Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Florida

Gainesville, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26583695 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28769559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32073464 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB202001011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.