End-stage Kidney Disease, Hemodialysis
Conditions
Keywords
intradialytic exercise
Brief 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.
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.
Interventions
BEHAVIORALIntradialytic Cycling
This intervention will consist of intradialytic cycling for 60 minutes 3 times per week for a total of 12 weeks.
Sponsors
University of Manitoba
Canadian Institutes of Health Research (CIHR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Data analysts will also be blinded to study group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from baseline to 12 weeks measured using echocardiography | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in post-hemodialysis high sensitivity Troponin T level from baseline to 12 weeks | Baseline to 12 weeks | Measured by Roche High-Sensitivity Troponin T assay at each site. |
| Change in difference between pre-hemodialysis and post-hemodialysis Troponin T from baseline to 12 weeks | Baseline to 12 weeks | Measured by Roche High-Sensitivity Troponin T assay at each site. |
| Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from baseline to 16 weeks measured using echocardiography | 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). |
| Change in severity of post-hemodialysis fatigue | 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?" |
| Change in Symptom Burden | 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 |
| Change in Exercise Capacity | Baseline to 12 weeks | Measured by the Incremental Shuttle Walk Test (ISWT) |
| Change in Physical Activity Behaviour Patterns | Baseline to 12 weeks | Assessed using total active minutes per day as measure by multi-directional accelerometry |
| Change in number of regional wall motion abnormalities at peak HD stress | Baseline to 1 week | Measured at each study time point to further assess how exercise training effects HD-related cardiac stunning over time |
| Feasiblity - Recruitment | Baseline to 12 weeks | Proportion of individuals eligible for study that were recruited |
| Feasibility - Eligibility | Baseline to 12 weeks | Proportion of individuals approached eligible for enrolment into study |
| Feasibility - Adherence | Baseline to 16 weeks | Proportion of participants that completed the study |
| Feasibility - Exercise Adherence: Proportion of exercise sessions completed | Baseline to 12 weeks | Proportion of total exercise sessions during study completed |
| Feasibility - Exercise Adherence: Total minutes of exercise | Baseline to 12 weeks | Proportion of total possible minutes of intradialytic cycling completed during the study |
| Change in Cognitive Function | Baseline to 12 weeks | Change in cognitive function score measured by Cambridge Brain Science testing |
| Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from 12 to 16 weeks measured using echocardiography | 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). |
Countries
Australia, Canada
Contacts
PRINCIPAL_INVESTIGATORClara Bohm, MD, MPH
University of Manitoba
Outcome results
None listed