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

Primary Purpose

Chronic Kidney Disease stage4, Chronic Kidney Disease Stage V, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EIM Fitness Practitioners
Counseling and wearable device
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Disease stage4 focused on measuring implementation

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Santa Clara Valley Nephrology
  • Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Counseling alone

Group exercise

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
October 9, 2017
Last Updated
January 24, 2022
Sponsor
Stanford University
Collaborators
Emory University, Santa Clara Valley Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03311763
Brief Title
Exercise is Medicine for Patients With CKD
Acronym
EIM-CKD
Official Title
A Multi-center Exercise Intervention for Persons Transitioning to Dialysis Using the "Exercise is Medicine" Framework
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Emory University, Santa Clara Valley Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease stage4, Chronic Kidney Disease Stage V, Physical Activity
Keywords
implementation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Counseling alone
Arm Type
Active Comparator
Arm Description
Group 1: physical activity assessment, brief counseling session + physical activity wearable
Arm Title
Group exercise
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
EIM Fitness Practitioners
Intervention Description
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
Intervention Name(s)
Counseling and wearable device
Intervention Description
Brief exercise counseling session and provision of a wearable fitness tracking device to promote physical activity.
Primary Outcome Measure Information:
Title
Differences in minutes of physical activity per week as measured by wearable device
Description
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
Time Frame
measured at baseline, 8 weeks and 16 weeks post start of intervention.
Secondary Outcome Measure Information:
Title
Six minute walk test (6MWT)
Description
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
Time Frame
measured at baseline, 8 weeks and 16 weeks post start of intervention.
Title
Handgrip
Description
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
Time Frame
measured at baseline, 8 weeks and 16 weeks post start of intervention.
Title
Health-related Quality of life using Medical Outcomes Short form 12
Description
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
Time Frame
measured at baseline, 8 weeks and 16 weeks post start of intervention.
Other Pre-specified Outcome Measures:
Title
Symptoms of Depression as measured by Center for Epidemiologic Studies Depression Scale (CESD20)
Description
Questionnaire based CESD-2 scale will be used to measure depression
Time Frame
measured at baseline, 8 weeks and 16 weeks post start of intervention.
Title
Physical activity self-efficacy questionnaire
Time Frame
measured at baseline, 8 weeks and 16 weeks post start of intervention.
Title
Waist circumference
Time Frame
measured at baseline, 8 weeks and 16 weeks post start of intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Santa Clara Valley Nephrology
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34939004
Citation
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.
Results Reference
background
PubMed Identifier
30208854
Citation
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.
Results Reference
background

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Exercise is Medicine for Patients With CKD

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