Implementing 3-Step Workout for Life in Home Health

NCT04709783 | Terminated Results

• 1 other identifier: IRB202001011
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 aim is to evaluate the implementation-related clinical and patient outcomes.

Conditions

Frailty; Disability or Chronic Disease Leading to Disablement

Outcome Measures

Primary Outcomes (1)

• Ratio OASIS (Outcome and Assessment Information Set) Items: Self-care

  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.

  Discharge, on average 2 months

Secondary Outcomes (3)

• Ratio OASIS (Outcome and Assessment Information Set) Items: Mobility

  Discharge, on average 2 months

• EuroQoL (European Quality of Life)

  Discharge, on average 2 months

• Activity Measure of Post-Acute Care-Home Health Version

  Discharge, on average 2 months

Study Arms (1)

Implementation Arm

EXPERIMENTAL

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

Other: 3-Step Workout for Life

Interventions

3-Step Workout for Life 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.

Implementation Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• American Occupational Therapy Foundation: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (3)

• 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.

  PMID: 26583695 BACKGROUND

• 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.

  PMID: 28769559 BACKGROUND

• 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.

  PMID: 32073464 BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Not able to meet the recruitment goal within the funding period, leading to small number of participants analyzed.

Results Point of Contact

• Title: Chiung-ju (CJ) Liu
• Organization: University of Florida

c.liu1@phhp.ufl.edu

352-273-6496

Study Officials

• Chiung-ju Liu, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 14, 2021
• Study Start: May 26, 2022
• Primary Completion: April 3, 2023
• Study Completion: June 5, 2023
• Last Updated: January 3, 2025
• Results First Posted: January 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)