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Chronic Kidney Disease stage4EIM-CKDNCT03311763

Exercise is Medicine for Patients With CKD

A study testing EIM Fitness Practitioners and Counseling and wearable device in people with Chronic Kidney Disease stage4 and Chronic Kidney Disease Stage V, run by Stanford University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 80 years
What is being tested?
EIM Fitness Practitioners and Counseling and wearable device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
2 sitesUnited States
Study dates
16 Apr 2018to 30 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • - 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

Who cannot join

  • - 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Santa Clara Valley Nephrology

    San Jose, California, 95128

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
EIM Fitness Practitioners, Counseling and wearable device
Keywords
implementation
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EIM Fitness PractitionersBehavioural

    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 deviceBehavioural

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

Study groups in NCT03311763
Study groupRoleWhat they receive
Counseling aloneActive comparatorGroup 1: physical activity assessment, brief counseling session + physical activity wearable
Receives: Behavioral: Counseling and wearable device
Group exerciseExperimentalGroup 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).
Receives: Behavioral: EIM Fitness Practitioners; Behavioral: Counseling and wearable device

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2017
  2. Study start16 Apr 2018
  3. Primary completion31 Dec 2020
  4. Study completion30 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03311763
Sponsor's protocol ID
IRB-43198
Acronym
EIM-CKD
Status last verified
Jan 2022
First submitted
9 Oct 2017
Last updated
8 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 34939004

  • 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.

    PubMed 30208854

Questions about this trial

What is this clinical trial studying?

A study testing EIM Fitness Practitioners and Counseling and wearable device in people with Chronic Kidney Disease stage4 and Chronic Kidney Disease Stage V, run by Stanford University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03311763, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.

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