A Multi-center Exercise Intervention for Persons Transitioning to Dialysis Using the "Exercise is Medicine" Framework
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 56
- Locations
- 2
- Primary Endpoint
- Differences in minutes of physical activity per week as measured by wearable device
Study Overview
Brief Summary
The investigators plan to integrate and tailor the existing Exercise is Medicine framework, an evidence-based multi-level intervention program developed by the American Society of Sports Medicine, for the care of patients with advanced chronic kidney disease. In this pilot randomized control trial, investigators will compare the effects and feasibility of two intervention arms designed to start and maintain physical activity in this high-risk population (Group 1: physical activity assessment, brief counseling session + physical activity wearable versus Group 2: Group 1 intervention components + referral to a free, community-based, EIM practitioner led group exercise program).
Detailed Description
Persons on dialysis are physically inactive, with most reporting activity levels below the fifth percentile of healthy age-matched groups. Physical inactivity in turn increases the risk for functional decline and mortality in this vulnerable population. The investigators propose a pragmatic clinical trial for an exercise intervention among persons transitioning to dialysis. The investigators will use an existing framework - Exercise is Medicine (EIM) - developed by the American College of Sports Medicine. The investigators will randomize 98 persons from two regions-Atlanta and Bay Area-in two intervention arms with incremental levels of clinical-community integration: physical activity assessment during Nephrology clinical visit, brief counseling at pre-dialysis education and physical activity wearable (group 1) versus group 1 intervention components plus a referral to a free, EIM practitioner-led group exercise program over 16 weeks (group 2; 8 week core intervention; 8 week follow up). The investigators will assess efficacy by comparing between group differences in minutes/week of (measured) moderate intensity physical activity. To evaluate implementation, investigators will use questionnaires and exit interviews for assessing barriers to referral, participation and retention along the path of the intervention; investigators will use cost-utility analyses to assess scalability. Further the investigators will have a plan for dissemination of the intervention by partnering with insurance providers and both for-profit and non-profit dialysis organizations. The overall goal is to inform the development of a practical, cost-conscious intervention that addresses barriers to physical activity commonly faced by persons on dialysis, and can be delivered as a "package" to interested practices.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- eGFR < 30 ml/min/1.73m2
- •Age ≥30 and ≤80 years
- •Noncompliance with physical activity guidelines
- •Not in precontemplation stage
- •Non-wheelchair bound
- •Able to provide informed consent in English or Spanish
- •Anticipated to be living in the area over the next 36 weeks
Exclusion Criteria
- •- Inability to provide consent in English
- •Diagnosed mental health disorder
- •Alcohol or drug abuse
- •No fixed address or contact details
- •Unstable angina or unstable arrhythmias
- •Lack of access to internet
- •Any concern not otherwise stated by patient's nephrologist
Arms & Interventions
Counseling alone
Group 1: physical activity assessment, brief counseling session + physical activity wearable
Intervention: Counseling and wearable device (Behavioral)
Group exercise
Group 2: Group 1 intervention components + referral to a free, community-based, EIM practitioner led group exercise program (two, 1 hour classes/week for 8 weeks).
Intervention: EIM Fitness Practitioners (Behavioral)
Group exercise
Group 2: Group 1 intervention components + referral to a free, community-based, EIM practitioner led group exercise program (two, 1 hour classes/week for 8 weeks).
Intervention: Counseling and wearable device (Behavioral)
Outcomes
Primary Outcomes
Differences in minutes of physical activity per week as measured by wearable device
Time Frame: measured at baseline, 8 weeks and 16 weeks post start of intervention.
The Garmin wearable device will be used to track physical activity minutes during the week, with differences in total minutes per week in baseline versus 8 weeks (and 16 weeks) post intervention compared between exercise classes versus counseling alone groups
Secondary Outcomes
- Six minute walk test (6MWT)(measured at baseline, 8 weeks and 16 weeks post start of intervention.)
- Handgrip(measured at baseline, 8 weeks and 16 weeks post start of intervention.)
- Health-related Quality of life using Medical Outcomes Short form 12(measured at baseline, 8 weeks and 16 weeks post start of intervention.)
Investigators
Shuchi Anand
Instructor in Medicine
Stanford University