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End-stage Kidney DiseaseNCT04877041

Exercise and Cardiac Stunning During HD

A study testing Intradialytic Cycling in people with End-stage Kidney Disease and Hemodialysis, run by University of Manitoba at 6 sites in 2 countries.

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 purpose of this study is to determine the effect of a 12-week cycling during hemodialysis program on hemodialysis-induced myocardial stunning in adult individuals receiving hemodialysis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End-stage Kidney Disease, Hemodialysis
What is being tested?
Intradialytic Cycling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
6 sitesin 2 countries
Study dates
1 Mar 2023to 11 Feb 2026
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults greater than or equal to 18 years old (no upper age limit); who are greater than; 3 months after starting maintenance hemodialysis
  • No expected change in dialysis modality, elective surgery or relocation outside of study site during the intervention period (16 weeks)
  • Assessed to be safe and able to exercise by the hemodialysis unit nephrologist
  • Able to communicate in English and provide written informed consent
  • Must be dialyzing thrice weekly

Who cannot join

  • Acute coronary syndrome in the past 3 months
  • Unstable arrhythmia
  • Shortness of breath at rest or with minimal activity (NYHA Class 4)
  • Symptomatic hypoglycemia (\>2x/week in week prior to enrolment)
  • Participating in clinical intradialytic cycling program in last 3 months (if a clinical program exists)

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Canada5 sites

  • University of Calgary Cumming School of Medicine Department of Internal Medicine

    Calgary, Alberta, T2N 2T9

  • University of Alberta Department of Internal Medicine

    Edmonton, Alberta, T6G 2G3

  • Western University

    London, Ontario, N6A5C1

  • St. Pauls Hospital

    Vancouver, British Columbia, V6Z1Y6

  • University of Manitoba Department of Internal Medicine

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Australia1 site

  • University of South Australia

    Adelaide, South Australia, 5001

Other trials in Australia

About this study

Official title: Trial of Intradialytic Cycling as Kidney Exercise Rehabilitation for Cardiac Stunning in Hemodialysis (TICKERS-HD)

The purpose of this study is to determine the effect of a 12-week cycling during hemodialysis program on hemodialysis-induced myocardial stunning in adult individuals receiving hemodialysis.

Read the detailed description

People with kidney failure receiving chronic hemodialysis (HD) suffer from post-HD treatment fatigue, poor functional status and high rates of cardiac failure and death. Previous work has shown that these outcomes are correlated with recurrent ischemic cardiac injury (myocardial stunning) that occurs during HD treatments. Myocardial stunning, identified by regional cardiac wall motion abnormalities (RWMA), is common during HD. Intradialytic cycling (during HD) decreases HD-induced stunning, and may improve adverse outcomes associated with stunning. We will use echocardiography (echo) to understand the effects of intradialytic aerobic exercise on myocardial stunning and HD-related symptoms.

Being tested
Intradialytic Cycling
Keywords
intradialytic exercise
Medical subject headings
Kidney Failure, Chronic

What participants receive

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

  • Intradialytic CyclingBehavioural

    This intervention will consist of intradialytic cycling for 60 minutes 3 times per week for a total of 12 weeks.

Study groups in NCT04877041
Study groupRoleWhat they receive
Exercise (Intradialytic Cycling)ExperimentalParticipants will receive a standardized baseline exercise counseling session as per control and then participate in a supervised intradialytic cycling program for 12-weeks
Receives: Behavioral: Intradialytic Cycling
Usual CareNo interventionParticipants will receive a standardized baseline exercise counseling session. Participants in the control group will not undergo formal exercise intervention, but will not be prohibited from participating in exercise outside of hemodialysis. They will be asked to not to participate in intradialytic cycling during the study (16 weeks total).

What is being measured

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

  1. Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from baseline to 12 weeks measured using echocardiography

    Using standard left ventricular apical 2-, 3-, and 4-chamber views and left ventricular parasternal short-axis views collected by the same trained operator at each site 3 times during the mid-week hemodialysis session at each assessment time point as follows: baseline (pre hemodialysis), post-cycling exercise (or mid-dialysis in controls) and at peak hemodialysis stress (~30 min prior to end of hemodialysis). Echocardiogram image analysis will be performed in London, ON using automated speckle-tracking analysis (EchoPAC-PC software version 110.1.3; GE Healthcare).

    Measured: Baseline to 12 weeks

Secondary outcomes (16)

  1. Change in post-hemodialysis high sensitivity Troponin T level from baseline to 12 weeks

    Measured by Roche High-Sensitivity Troponin T assay at each site.

    Measured: Baseline to 12 weeks

  2. Change in difference between pre-hemodialysis and post-hemodialysis Troponin T from baseline to 12 weeks

    Measured by Roche High-Sensitivity Troponin T assay at each site.

    Measured: Baseline to 12 weeks

  3. Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from baseline to 16 weeks measured using echocardiography

    Using standard left ventricular apical 2-, 3-, and 4-chamber views and left ventricular parasternal short-axis views collected by the same trained operator at each site 3 times during the mid-week hemodialysis session at each assessment time point as follows: baseline (pre hemodialysis), post-cycling exercise (or mid-dialysis in controls) and at peak hemodialysis stress (~30 min prior to end of hemodialysis). Echocardiogram image analysis will be performed in London, ON using automated speckle-tracking analysis (EchoPAC-PC software version 110.1.3; GE Healthcare).

    Measured: Baseline to 16 weeks

  4. Change in severity of post-hemodialysis fatigue

    Assessed by the self-reported answer (in minutes) to the question: "How long does it take you to recover from a dialysis session and resume your normal, usual activities?"

    Measured: Baseline to 12 weeks

  5. Change in Symptom Burden

    Measured using the Dialysis Symptom Index (DSI) Severity Score. Score 0 to 150 with 0 no symptoms and 150 most number and severity of symptoms

    Measured: Baseline to 12 weeks

  6. Change in Exercise Capacity

    Measured by the Incremental Shuttle Walk Test (ISWT)

    Measured: Baseline to 12 weeks

  7. Change in Physical Activity Behaviour Patterns

    Assessed using total active minutes per day as measure by multi-directional accelerometry

    Measured: Baseline to 12 weeks

  8. Change in number of regional wall motion abnormalities at peak HD stress

    Measured at each study time point to further assess how exercise training effects HD-related cardiac stunning over time

    Measured: Baseline to 1 week

  9. Change in number of regional wall motion abnormalities at peak HD stress

    Measured at each study time point to further assess how exercise training effects HD-related cardiac stunning over time

    Measured: Baseline to 16 weeks

  10. Feasiblity - Recruitment

    Proportion of individuals eligible for study that were recruited

    Measured: Baseline to 12 weeks

  11. Feasibility - Eligibility

    Proportion of individuals approached eligible for enrolment into study

    Measured: Baseline to 12 weeks

  12. Feasibility - Adherence

    Proportion of participants that completed the study

    Measured: Baseline to 16 weeks

  13. Feasibility - Exercise Adherence: Proportion of exercise sessions completed

    Proportion of total exercise sessions during study completed

    Measured: Baseline to 12 weeks

  14. Feasibility - Exercise Adherence: Total minutes of exercise

    Proportion of total possible minutes of intradialytic cycling completed during the study

    Measured: Baseline to 12 weeks

  15. Change in Cognitive Function

    Change in cognitive function score measured by Cambridge Brain Science testing

    Measured: Baseline to 12 weeks

  16. Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from 12 to 16 weeks measured using echocardiography

    Using standard left ventricular apical 2-, 3-, and 4-chamber views and left ventricular parasternal short-axis views collected by the same trained operator at each site 3 times during the mid-week hemodialysis session at each assessment time point as follows: baseline (pre hemodialysis), post-cycling exercise (or mid-dialysis in controls) and at peak hemodialysis stress (~30 min prior to end of hemodialysis). Echocardiogram image analysis will be performed in London, ON using automated speckle-tracking analysis (EchoPAC-PC software version 110.1.3; GE Healthcare).

    Measured: From 12 to 16 weeks

Timeline

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

  1. First posted7 May 2021
  2. Study start1 Mar 2023
  3. Primary completion14 Jan 2026
  4. Study completion11 Feb 2026

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04877041
Sponsor's protocol ID
HS24857 (B2021:039)
Status last verified
May 2026
First submitted
3 May 2021
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bennett PN, Penny JD, McIntyre CW, Vanderlinden J, Borkum MS, Castillo G, Collister D, Corradetti B, Duhamel TA, Farion H, Ford E, Garcia E, Getachew R, Jesudason S, Kiaii M, Leu RL, Presseau J, Rigatto C, Seitz AK, Shirazi M, Soni A, Stewart K, Tarca B, Tennankore K, Verdin N, Whitlock R, Wilund K, Thompson S, MacRae JM, Bohm C. Randomized Controlled Trial of Intradialytic Cycling as Kidney Exercise Rehabilitation for Cardiac Stunning in Hemodialysis (TICKERS_HD): A Clinical Research Protocol. Can J Kidney Health Dis. 2026 Jan 17;13:20543581251391112. doi: 10.1177/20543581251391112. eCollection 2026.

    PubMed 41555861

  • McIntyre CW. Update on Hemodialysis-Induced Multiorgan Ischemia: Brains and Beyond. J Am Soc Nephrol. 2024 May 1;35(5):653-664. doi: 10.1681/ASN.0000000000000299. Epub 2024 Jan 26.

    PubMed 38273436

Questions about this trial

What is this clinical trial studying?

A study testing Intradialytic Cycling in people with End-stage Kidney Disease and Hemodialysis, run by University of Manitoba at 6 sites in 2 countries.

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 5 inclusion and 5 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 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada, Australia. 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?

Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from baseline to 12 weeks measured using echocardiography (time frame: Baseline to 12 weeks). 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 NCT04877041, 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 15 May 2026.

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