EIM-CKD: Exercise is Medicine for Patients With CKD

Sponsor

Stanford University (Other)

Overall Status

Completed

CT.gov ID

NCT03311763

Collaborator

Emory University (Other), Santa Clara Valley Medical Center (Other)

Enrollment

Locations

Arms

43.5

Actual Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease stage4 Chronic Kidney Disease Stage V Physical Activity	Behavioral: EIM Fitness Practitioners Behavioral: Counseling and wearable device	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Apr 16, 2018

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Nov 30, 2021

Arms and Interventions

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

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: 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.

Behavioral: Counseling and wearable device

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

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Symptoms of Depression as measured by Center for Epidemiologic Studies Depression Scale (CESD20) [measured at baseline, 8 weeks and 16 weeks post start of intervention.]
Questionnaire based CESD-2 scale will be used to measure depression
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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Santa Clara Valley Nephrology	San Jose	California	United States	95128
2	Emory University	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

Stanford University
Emory University
Santa Clara Valley Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Shuchi Anand, Instructor in Medicine, Stanford University

ClinicalTrials.gov Identifier:

NCT03311763

Other Study ID Numbers:

IRB-43198

First Posted:

Oct 17, 2017

Last Update Posted:

Feb 8, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Shuchi Anand, Instructor in Medicine, Stanford University

implementation

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Feb 8, 2022