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Exercise and Cardiac Stunning During HD

RECRUITING

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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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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)
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-03-01

    Primary completion: 2025-03-01

    Study completion finish: 2025-09-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT04877041

    Intervention or treatment

    BEHAVIORAL: Intradialytic Cycling

    Conditions

    • End-stage Kidney Disease
    • Hemodialysis

    Find a site

    Closest Location:

    University of South Australia

    Research sites nearby

    Select from list below to view details:

    • University of South Australia

      Adelaide, South Australia, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Exercise (Intradialytic Cycling)
    • Participants will receive a standardized baseline exercise counseling session as per control and then participate in a supervised intradialytic cycling program for 12-weeks
    BEHAVIORAL: Intradialytic Cycling
    • This intervention will consist of intradialytic cycling for 60 minutes 3 times per week for a total of 12 weeks.
    NO_INTERVENTION: Usual Care
    • Participants 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).
    Not specified

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from baseline to 12 weeks measured using echocardiographyUsing 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).Baseline to 12 weeks

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Change in post-hemodialysis high sensitivity Troponin T level from baseline to 12 weeksMeasured by Roche High-Sensitivity Troponin T assay at each site.Baseline to 12 weeks
    Change in difference between pre-hemodialysis and post-hemodialysis Troponin T from baseline to 12 weeksMeasured by Roche High-Sensitivity Troponin T assay at each site.Baseline to 12 weeks
    Change in severity of post-hemodialysis fatigueAssessed 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?"Baseline to 12 weeks
    Change in Symptom BurdenMeasured using the Dialysis Symptom Index (DSI) Severity Score. Score 0 to 150 with 0 no symptoms and 150 most number and severity of symptomsBaseline to 12 weeks
    Change in Exercise CapacityMeasured by the Incremental Shuttle Walk Test (ISWT)Baseline to 12 weeks
    Change in Physical Activity Behaviour PatternsAssessed using total active minutes per day as measure by multi-directional accelerometryBaseline to 12 weeks
    Change in number of regional wall motion abnormalities at peak HD stressMeasured at each study time point to further assess how exercise training effects HD-related cardiac stunning over timeBaseline to 1 week
    Change in number of regional wall motion abnormalities at peak HD stressMeasured at each study time point to further assess how exercise training effects HD-related cardiac stunning over timeBaseline to 16 weeks
    Feasiblity - RecruitmentProportion of individuals eligible for study that were recruitedBaseline to 12 weeks
    Feasibility - EligibilityProportion of individuals approached eligible for enrolment into studyBaseline to 12 weeks
    Feasibility - AdherenceProportion of participants that completed the studyBaseline to 16 weeks
    Feasibility - Exercise Adherence: Proportion of exercise sessions completedProportion of total exercise sessions during study completedBaseline to 12 weeks
    Feasibility - Exercise Adherence: Total minutes of exerciseProportion of total possible minutes of intradialytic cycling completed during the studyBaseline to 12 weeks
    Change in Cognitive FunctionChange in cognitive function score measured by Cambridge Brain Science testingBaseline to 12 weeks

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    References

    Clinical Trials Gov: Exercise and Cardiac Stunning During HD

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