Clinical trial NCT04709783: Implementing 3-Step Workout for Life in Home Health
Official title: Implementing 3-Step Workout for Life to Improve ADL Outcome in Home Health
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Frailty
Disability or Chronic Disease Leading to Disablement
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: American Occupational Therapy Foundation
First posted: 2021-01-14
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ratio OASIS (Outcome and Assessment Information Set) Items: Self-care
timeFrame: Discharge, on average 2 months
Secondary outcomes:
measure: Ratio OASIS (Outcome and Assessment Information Set) Items: Mobility
timeFrame: Discharge, on average 2 months
measure: EuroQoL (European Quality of Life)
timeFrame: Discharge, on average 2 months
measure: Activity Measure of Post-Acute Care-Home Health Version
timeFrame: Discharge, on average 2 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Chiung-ju Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.