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
About this trial
This is an interventional health services research trial for Chronic Kidney Disease stage4 focused on measuring implementation
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
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
NCT ID
NCT03311763
First Posted
October 9, 2017
Last Updated
January 24, 2022
Sponsor
Stanford University
Collaborators
Emory University, Santa Clara Valley Medical Center
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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