Exercise and Cardiac Stunning During HD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hemodialysis, End-stage Kidney Disease

Intervention / Treatment
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* Behavioral: Intradialytic Cycling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults > or equal to 18 years old (no upper age limit); who are > 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 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 6 months (if a clinical program exists)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise (Intradialytic Cycling)<br>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<br>* This intervention will consist of intradialytic cycling for 60 minutes 3 times per week for a total of 12 weeks.<br>|
| No Intervention: Usual Care<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 12 weeks | 
| 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. | Baseline to 12 weeks | 
| 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? | Baseline to 12 weeks | 
| 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 | Baseline to 12 weeks | 
| Change in Exercise Capacity | Measured by the Incremental Shuttle Walk Test (ISWT) | Baseline to 12 weeks | 
| Change in Physical Activity Behaviour Patterns | Assessed using total active minutes per day as measure by multi-directional accelerometry | Baseline to 12 weeks | 
| 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 | Baseline to 1 week | 
| 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 | Baseline to 16 weeks | 
| Feasiblity - Recruitment | Proportion of individuals eligible for study that were recruited | Baseline to 12 weeks | 
| Feasibility - Eligibility | Proportion of individuals approached eligible for enrolment into study | Baseline to 12 weeks | 
| Feasibility - Adherence | Proportion of participants that completed the study | Baseline to 16 weeks | 
| Feasibility - Exercise Adherence: Proportion of exercise sessions completed | Proportion of total exercise sessions during study completed | Baseline to 12 weeks | 
| Feasibility - Exercise Adherence: Total minutes of exercise | Proportion of total possible minutes of intradialytic cycling completed during the study | Baseline to 12 weeks | 
| Change in Cognitive Function | Change in cognitive function score measured by Cambridge Brain Science testing | Baseline to 12 weeks |