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Completed

NCT Number: NCT03311763

Exercise is Medicine for Patients With CKD

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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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Clara Valley Nephrology, San Jose, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EIM Fitness Practitioners

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

Behavioral

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

Primary outcomes

  1. 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

  1. Six minute walk test (6MWT)

    Time frame: 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

  2. Handgrip

    Time frame: 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

  3. Health-related Quality of life using Medical Outcomes Short form 12

    Time frame: 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

Other outcomes

  1. Symptoms of Depression as measured by Center for Epidemiologic Studies Depression Scale (CESD20)

    Time frame: measured at baseline, 8 weeks and 16 weeks post start of intervention.

    Questionnaire based CESD-2 scale will be used to measure depression

  2. Physical activity self-efficacy questionnaire

    Time frame: measured at baseline, 8 weeks and 16 weeks post start of intervention.

  3. Waist circumference

    Time frame: measured at baseline, 8 weeks and 16 weeks post start of intervention.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Emory University
  • Santa Clara Valley Medical Center

Registry information

Official study title

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

Acronym: EIM-CKD

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 17, 2017
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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