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Completed

NCT Number: NCT04877041

Exercise and Cardiac Stunning During 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.

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Key information

Conditions

End-stage Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Australia, Adelaide, South Australia, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Intradialytic Cycling

Behavioral

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

Primary outcomes

  1. 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

    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).

Secondary outcomes

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

    Time frame: Baseline to 12 weeks

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

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

    Time frame: Baseline to 12 weeks

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

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

    Time frame: Baseline to 16 weeks

    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).

  4. Change in severity of post-hemodialysis fatigue

    Time frame: Baseline to 12 weeks

    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?"

  5. Change in Symptom Burden

    Time frame: Baseline to 12 weeks

    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

  6. Change in Exercise Capacity

    Time frame: Baseline to 12 weeks

    Measured by the Incremental Shuttle Walk Test (ISWT)

  7. Change in Physical Activity Behaviour Patterns

    Time frame: Baseline to 12 weeks

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

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

    Time frame: Baseline to 1 week

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

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

    Time frame: Baseline to 16 weeks

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

  10. Feasiblity - Recruitment

    Time frame: Baseline to 12 weeks

    Proportion of individuals eligible for study that were recruited

  11. Feasibility - Eligibility

    Time frame: Baseline to 12 weeks

    Proportion of individuals approached eligible for enrolment into study

  12. Feasibility - Adherence

    Time frame: Baseline to 16 weeks

    Proportion of participants that completed the study

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

    Time frame: Baseline to 12 weeks

    Proportion of total exercise sessions during study completed

  14. Feasibility - Exercise Adherence: Total minutes of exercise

    Time frame: Baseline to 12 weeks

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

  15. Change in Cognitive Function

    Time frame: Baseline to 12 weeks

    Change in cognitive function score measured by Cambridge Brain Science testing

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

    Time frame: From 12 to 16 weeks

    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).

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 7, 2021
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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