Studies
| Study First Submitted Date | 2021-01-07 |
| Study First Posted Date | 2021-01-14 |
| Last Update Posted Date | 2023-07-13 |
| Start Month Year | May 26, 2022 |
| Primary Completion Month Year | April 3, 2023 |
| Verification Month Year | July 2023 |
| Verification Date | 2023-07-31 |
| Last Update Posted Date | 2023-07-13 |
Detailed Descriptions
| Sequence: | 20792699 |
| 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. |
Facilities
| Sequence: | 200734483 |
| Name | University of Florida |
| City | Gainesville |
| State | Florida |
| Zip | 32610 |
| Country | United States |
Conditions
| Sequence: | 52353882 | Sequence: | 52353883 |
| Name | Frailty | Name | Disability or Chronic Disease Leading to Disablement |
| Downcase Name | frailty | Downcase Name | disability or chronic disease leading to disablement |
Id Information
| Sequence: | 40289436 |
| Id Source | org_study_id |
| Id Value | IRB202001011 |
Countries
| Sequence: | 42711533 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55796275 |
| Group Type | Experimental |
| Title | Implementation Arm |
| Description | Participants will receive the 3-Step Workout for Life program and other rehabilitation services based on the plan of care. |
Interventions
| Sequence: | 52664796 |
| Intervention Type | Other |
| Name | 3-Step Workout for Life |
| Description | 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. |
Design Outcomes
| Sequence: | 178052861 | Sequence: | 178052862 | Sequence: | 178052863 | Sequence: | 178052864 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Self-care items from the Outcome and Assessment Information Set (OASIS) | Measure | Mobility items from the Outcome and Assessment Information Set (OASIS) | Measure | EuroQoL (EQ-5D-5L) | Measure | Activity Measure Post Acute Care (AM-PAC): Home Care Short Form |
| Time Frame | Change from admission to discharge which is a period of about two months | Time Frame | Change from admission to discharge which is a period of about two months | Time Frame | Change from admission to discharge which is a period of about two months | Time Frame | Change from admission to discharge which is a period of about two months |
| Description | 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. | Description | 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. | Description | 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. | Description | 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. |
Browse Conditions
| Sequence: | 194181228 | Sequence: | 194181229 | Sequence: | 194181230 | Sequence: | 194181231 |
| Mesh Term | Frailty | Mesh Term | Chronic Disease | Mesh Term | Pathologic Processes | Mesh Term | Disease Attributes |
| Downcase Mesh Term | frailty | Downcase Mesh Term | chronic disease | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | disease attributes |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48489166 | Sequence: | 48489167 |
| Agency Class | OTHER | Agency Class | OTHER |
| Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
| Name | University of Florida | Name | American Occupational Therapy Foundation |
Overall Officials
| Sequence: | 29381861 |
| Role | Principal Investigator |
| Name | Chiung-ju Liu, PhD |
| Affiliation | University of Florida |
Design Group Interventions
| Sequence: | 68398259 |
| Design Group Id | 55796275 |
| Intervention Id | 52664796 |
Eligibilities
| Sequence: | 30870675 |
| Gender | All |
| Minimum Age | 65 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| 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 |
| Adult | False |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254031064 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2021 |
| Actual Duration | 10 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Minimum Age Num | 65 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 3 |
Designs
| Sequence: | 30616473 |
| Allocation | N/A |
| Intervention Model | Single Group Assignment |
| Observational Model | |
| Primary Purpose | Other |
| Time Perspective | |
| Masking | None (Open Label) |
Responsible Parties
| Sequence: | 28983011 |
| Responsible Party Type | Sponsor |
Study References
| Sequence: | 52256835 | Sequence: | 52256836 | Sequence: | 52256837 |
| Pmid | 26583695 | Pmid | 28769559 | Pmid | 32073464 |
| Reference Type | background | Reference Type | background | Reference Type | background |
| 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. |