Exercise is Medicine for Patients With CKD (EIM-CKD)

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

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).

Study Overview

• Status: Completed
• Conditions: Physical Activity; Chronic Kidney Disease stage4; Chronic Kidney Disease Stage V
• Intervention / Treatment: Behavioral: Counseling and wearable device; Behavioral: EIM Fitness Practitioners

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States, 95128
      • Santa Clara Valley Nephrology
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Counseling alone; Group 1: physical activity assessment, brief counseling session + physical activity wearable	Behavioral: Counseling and wearable device; Brief exercise counseling session and provision of a wearable fitness tracking device to promote physical activity.
Experimental: 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).	Behavioral: Counseling and wearable device; Brief exercise counseling session and provision of a wearable fitness tracking device to promote physical activity.; Behavioral: 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.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of Depression as measured by Center for Epidemiologic Studies Depression Scale (CESD20)	Questionnaire based CESD-2 scale will be used to measure depression	measured at baseline, 8 weeks and 16 weeks post start of intervention.
Physical activity self-efficacy questionnaire		measured at baseline, 8 weeks and 16 weeks post start of intervention.
Waist circumference		measured at baseline, 8 weeks and 16 weeks post start of intervention.

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Emory University; Santa Clara Valley Medical Center

Publications and helpful links

General Publications

• Anand S, Ziolkowski SL, Bootwala A, Li J, Pham N, Cobb J, Lobelo F. Group-Based Exercise in CKD Stage 3b to 4: A Randomized Clinical Trial. Kidney Med. 2021 Jul 8;3(6):951-961.e1. doi: 10.1016/j.xkme.2021.04.022. eCollection 2021 Nov-Dec.
• Jagannathan R, Ziolkowski SL, Weber MB, Cobb J, Pham N, Long J, Anand S, Lobelo F. Physical activity promotion for patients transitioning to dialysis using the "Exercise is Medicine" framework: a multi-center randomized pragmatic trial (EIM-CKD trial) protocol. BMC Nephrol. 2018 Sep 12;19(1):230. doi: 10.1186/s12882-018-1032-0.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: October 9, 2017
• First Submitted That Met QC Criteria: October 14, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: implementation
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: IRB-43198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes