Implementing 3-Step Workout for Life in Home Health

Frailty Clinical Trial

Official title:

Implementing 3-Step Workout for Life to Improve ADL Outcome in Home Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709783
• Other study ID #: IRB202001011
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Disease
• Disability or Chronic Disease Leading to Disablement
• Frailty

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