Exercise is Medicine for Patients With CKD

Not Applicable

Completed

• Conditions: Physical Activity; Chronic Kidney Disease stage4; Chronic Kidney Disease Stage V
• Interventions: Behavioral: EIM Fitness Practitioners; Behavioral: Counseling and wearable device

• Registration Number: NCT03311763
• Lead Sponsor: Stanford University

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 Timeline

• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-10-14
• Study First Posted: 2017-10-17
• Study Start: 2018-04-16
• Primary Completion: 2020-12-31
• Study Completion: 2021-11-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group exercise	Counseling and wearable device	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).
Counseling alone	Counseling and wearable device	Group 1: physical activity assessment, brief counseling session + physical activity wearable
Group exercise	EIM Fitness Practitioners	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).

Primary Outcome Measures

Name	Time	Method
Differences in minutes of physical activity per week as measured by wearable device	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 Outcome Measures

Name	Time	Method
Six minute walk test (6MWT)	measured at baseline, 8 weeks and 16 weeks post start of intervention.	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
Handgrip	measured at baseline, 8 weeks and 16 weeks post start of intervention.	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
Health-related Quality of life using Medical Outcomes Short form 12	measured at baseline, 8 weeks and 16 weeks post start of intervention.	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

Trial Locations

Locations (2)

Santa Clara Valley Nephrology; 🇺🇸 San Jose, California, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States