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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
111
This intervention will consist of intradialytic cycling for 60 minutes 3 times per week for a total of 12 weeks.
University of South Australia
Adelaide, South Australia, Australia
University of Calgary Cumming School of Medicine Department of Internal Medicine
Calgary, Alberta, Canada
University of Alberta Department of Internal Medicine
Edmonton, Alberta, Canada
St. Pauls Hospital
Vancouver, British Columbia, Canada
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).
Time frame: Baseline to 12 weeks
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.
Time frame: 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.
Time frame: Baseline to 12 weeks
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).
Time frame: Baseline to 16 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Manitoba Department of Internal Medicine
Winnipeg, Manitoba, Canada
Western University
London, Ontario, Canada
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?"
Time frame: 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
Time frame: Baseline to 12 weeks
Change in Exercise Capacity
Measured by the Incremental Shuttle Walk Test (ISWT)
Time frame: Baseline to 12 weeks
Change in Physical Activity Behaviour Patterns
Assessed using total active minutes per day as measure by multi-directional accelerometry
Time frame: 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
Time frame: 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
Time frame: Baseline to 16 weeks
Feasiblity - Recruitment
Proportion of individuals eligible for study that were recruited
Time frame: Baseline to 12 weeks
Feasibility - Eligibility
Proportion of individuals approached eligible for enrolment into study
Time frame: Baseline to 12 weeks
Feasibility - Adherence
Proportion of participants that completed the study
Time frame: Baseline to 16 weeks
Feasibility - Exercise Adherence: Proportion of exercise sessions completed
Proportion of total exercise sessions during study completed
Time frame: Baseline to 12 weeks
Feasibility - Exercise Adherence: Total minutes of exercise
Proportion of total possible minutes of intradialytic cycling completed during the study
Time frame: Baseline to 12 weeks
Change in Cognitive Function
Change in cognitive function score measured by Cambridge Brain Science testing
Time frame: Baseline to 12 weeks
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).
Time frame: From 12 to 16 weeks