FrailtyNCT04709783
Implementing 3-Step Workout for Life in Home Health
A study testing 3-Step Workout for Life in people with Frailty and Disability or Chronic Disease Leading to Disablement, run by University of Florida at 1 site in United States.
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 aim is to evaluate the implementation-related clinical and patient outcomes. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Disability or Chronic Disease Leading to Disablement
- What is being tested?
- 3-Step Workout for Life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2022to 5 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing 3-Step Workout for Life to Improve ADL Outcome in Home Health
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.
Read the 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.
- Being tested
- 3-Step Workout for Life
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-Step Workout for LifeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Implementation Arm | Experimental | Participants will receive the 3-Step Workout for Life program and other rehabilitation services based on the plan of care. Receives: Other: 3-Step Workout for Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Discharge, on average 2 months
Secondary outcomes (3)
Ratio OASIS (Outcome and Assessment Information Set) Items: Mobility
The mobility measure from OASIS evaluates the degree of independence in 17 mobility activities, such as roll left and right or sit to lying. 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 17 mobility activities, the ratio score of this participant is 0.17= 0.06 (17*1/17*6). The ratio score of OASIS mobility ranges from 0.17 (totally dependent on all mobility activities) to 1 (totally independent of all mobility activities). A higher ratio score means a higher ability to perform mobility tasks independently.
Measured: Discharge, on average 2 months
EuroQoL (European Quality of Life)
EuroQoL is a self-reported quality of life measure. The EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) evaluates health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. An index score ranges from -0.59 (worst health) to 1 (best health).
The EQ VAS (EuroQol_visual analogue scale) records the patient's self-rated health on a vertical visual analog scale ranging from 0 to 100. A higher score indicates better self-perceived health status.
Measured: Discharge, on average 2 months
Activity Measure of Post-Acute Care-Home Health Version
The measure evaluates the degree of difficulty in performing tasks in three domains: basic mobility, daily activities, and cognitive tasks. The raw score under each domain is then converted to a standardized T-scale score. According to the testing manual, the T-scale score range for basic mobility is from 30.36 to 70.71, for daily activities is from 22.45 to 61.92, and for applied cognition is from 9.89 to 49.40. A higher score indicates a better mobility, daily activities, or functional cognition performance. The manual does not provide information on clinically relevant thresholds or mean/SD of the T-scale.
Measured: Discharge, on average 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start26 May 2022
- Primary completion3 Apr 2023
- Study completion5 Jun 2023
Why it stopped: Not able to recruit sufficient participants during the funding period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Responsible party
- Sponsor
- Investigators
- Chiung-ju Liu, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709783
- Sponsor's protocol ID
- IRB202001011
- Status last verified
- Nov 2024
- First submitted
- 7 Jan 2021
- Last updated
- 3 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26583695Liu 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.
PubMed 28769559Liu 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.
PubMed 32073464
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing 3-Step Workout for Life to Improve ADL Outcome in Home Health
- ClinicalTrials.gov ID
- NCT04709783
- Acronym / sponsor ID
- IRB202001011
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not able to recruit sufficient participants during the funding period.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Study start
- 26 May 2022 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Posted 3 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implementation Arm | Experimental | Other: 3-Step Workout for LifeParticipants will receive the 3-Step Workout for Life program and other rehabilitation services based on the plan of care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-Step Workout for LifeParticipants 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. | Other | Implementation Arm |
Primary outcome
Ratio OASIS (Outcome and Assessment Information Set) Items: Self-care
Time frame: Discharge, on average 2 months
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.
3 secondary outcomes
Ratio OASIS (Outcome and Assessment Information Set) Items: Mobility
Time frame: Discharge, on average 2 months
EuroQoL (European Quality of Life)
Time frame: Discharge, on average 2 months
Activity Measure of Post-Acute Care-Home Health Version
Time frame: Discharge, on average 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26583695Liu 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.
- Background: PubMed 28769559Liu 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.
- Background: PubMed 32073464Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiung-ju Liu, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-Step Workout for Life in people with Frailty and Disability or Chronic Disease Leading to Disablement, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio OASIS (Outcome and Assessment Information Set) Items: Self-care (time frame: Discharge, on average 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04709783, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.