ClinicalTrials.gg
CompletedNCT03311763EIM-CKDUpdated Feb 8, 2022

Exercise is Medicine for Patients With CKD

An interventional study of EIM Fitness Practitioners and Counseling and wearable device in Chronic Kidney Disease stage4, Chronic Kidney Disease Stage V and Physical Activity, sponsored by Stanford University. Completed at 2 sites in United States. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-08.

Sponsored by Stanford University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 35 studies in Motor Activity by Stanford University — 7 open to participants now, 9 under way, none of them phase 3. Motor Activity · Stanford University.

Enrollment
21st of 33
56 · median 79
Started
2018
with 1 other
No phase
28 of 35
7 open now
Registered
21st of 35
by date

Among the 35 studies in Motor Activity by Stanford University, this one is the 21st largest by enrollment of the 33 interventional ones that give a count, is one of 2 that started in 2018, is one of 28 with no phase, and was the 21st registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

7 of the 35 studies in Motor Activity by Stanford University are open now, in 1 country. Recruiting first, the newest first:

2 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 30 Years to 80 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 35 studies in Motor Activity by Stanford University, or all of them as a file.
02

Study 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).

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.

03

Conditions studied

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

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Keywords

  • implementation
04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • \< 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 in English or Spanish
  • Anticipated to be living in the area over the next 36 weeks

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Active comparator
    Counseling alone

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

    Behavioral: Counseling and wearable device

  • 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 · Behavioral: Counseling and wearable device

Interventions

  • BehavioralEIM 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.

  • BehavioralCounseling and wearable device

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

06

What researchers measure

Primary outcomes

  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

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

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

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

Other outcomes

  1. Symptoms of Depression as measured by Center for Epidemiologic Studies Depression Scale (CESD20)

    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.

  2. Physical activity self-efficacy questionnaire

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

  3. Waist circumference

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

07

Study locations

2 sites
  • Santa Clara Valley Nephrology
    San Jose, California 95128, United States
  • Emory University
    Atlanta, Georgia 30322, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Dec 2020, 32 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 32 months is above that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2017
First posted
Oct 17, 2017
StartActual
Apr 16, 2018
Primary completionActual
Dec 31, 2020
CompletionActual
Nov 30, 2021
Last update
Feb 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03311763
Collaborators
Emory University, Santa Clara Valley Medical Center
Responsible party
Shuchi Anand (Instructor in Medicine, Stanford University) — Principal investigator
First posted
Oct 17, 2017
Start date
Apr 16, 2018
Primary completion
Dec 31, 2020
Completion
Nov 30, 2021
Last update
Feb 8, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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