Exercise is Medicine for Patients With CKD

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi-center Exercise Intervention for Persons Transitioning to Dialysis Using the Exercise is Medicine Framework

Conditions
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Chronic Kidney Disease stage4, Chronic Kidney Disease Stage V, Physical Activity

Intervention / Treatment
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* Behavioral: EIM Fitness Practitioners
* Behavioral: Counseling and wearable device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Counseling alone<br>Group 1: physical activity assessment, brief counseling session + physical activity wearable | Behavioral: Counseling and wearable device<br>* Brief exercise counseling session and provision of a wearable fitness tracking device to promote physical activity.<br>|
| Experimental: Group exercise<br>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). | Behavioral: EIM Fitness Practitioners<br>* Exercise is Medicine Practitioners will facilitate peer groups that attend twice-weekly exercise classes for 8 weeks, with clinical monitoring and advise regarding increasing physical activity.<br>Behavioral: Counseling and wearable device<br>* Brief exercise counseling session and provision of a wearable fitness tracking device to promote physical activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in minutes of physical activity per week as measured by wearable device | 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 | measured at baseline, 8 weeks and 16 weeks post start of intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six minute walk test (6MWT) | 6 minute walk test will be administered by research personnel in 100 feet walkway, with differences in distance walked between baseline and 8 weeks (and 16 weeks), compared between group exercise and counseling alone groups | measured at baseline, 8 weeks and 16 weeks post start of intervention. | 
| Handgrip | Dynamometers will be used to measure handgrip strength, with differences in distance walked between baseline and 8 weeks (and 16 weeks), compared between group exercise and counseling alone groups | measured at baseline, 8 weeks and 16 weeks post start of intervention. | 
| Health-related Quality of life using Medical Outcomes Short form 12 | Questionnaire based Sf12 will be used to measure health related quality of life, with differences in distance walked between baseline and 8 weeks (and 16 weeks), compared between group exercise and counseling alone groups | measured at baseline, 8 weeks and 16 weeks post start of intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implementation