Exercise is Medicine for Patients With CKD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-16

Study Completion Date

2021-11-30

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).

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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.

Conditions

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Chronic Kidney Disease stage4 Chronic Kidney Disease Stage V Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Counseling alone

Group 1: physical activity assessment, brief counseling session + physical activity wearable

Group Type ACTIVE_COMPARATOR

Counseling and wearable device

Intervention Type BEHAVIORAL

Brief exercise counseling session and provision of a wearable fitness tracking device to promote physical activity.

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).

Group Type EXPERIMENTAL

EIM Fitness Practitioners

Intervention Type BEHAVIORAL

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.

Counseling and wearable device

Intervention Type BEHAVIORAL

Brief exercise counseling session and provision of a wearable fitness tracking device to promote physical activity.

Interventions

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EIM Fitness Practitioners

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.

Intervention Type BEHAVIORAL

Counseling and wearable device

Brief exercise counseling session and provision of a wearable fitness tracking device to promote physical activity.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No