Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise (Intradialytic Cycling) | Experimental | Participants will receive a standardized baseline exercise counseling session as per control and then participate in a supervised intradialytic cycling program for 12-weeks |
|
| Usual Care | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intradialytic Cycling | Behavioral | This intervention will consist of intradialytic cycling for 60 minutes 3 times per week for a total of 12 weeks. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clara Bohm, MD, MPH | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Australia | Adelaide | South Australia | 5001 | Australia | ||
| University of Calgary Cumming School of Medicine Department of Internal Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41555861 | Derived | Bennett PN, Penny JD, McIntyre CW, Vanderlinden J, Borkum MS, Castillo G, Collister D, Corradetti B, Duhamel TA, Farion H, Ford E, Garcia E, Getachew R, Jesudason S, Kiaii M, Leu RL, Presseau J, Rigatto C, Seitz AK, Shirazi M, Soni A, Stewart K, Tarca B, Tennankore K, Verdin N, Whitlock R, Wilund K, Thompson S, MacRae JM, Bohm C. Randomized Controlled Trial of Intradialytic Cycling as Kidney Exercise Rehabilitation for Cardiac Stunning in Hemodialysis (TICKERS_HD): A Clinical Research Protocol. Can J Kidney Health Dis. 2026 Jan 17;13:20543581251391112. doi: 10.1177/20543581251391112. eCollection 2026. | |
| 38273436 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Data analysts will also be blinded to study group
Measured by Roche High-Sensitivity Troponin T assay at each site. |
| 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). | Baseline to 16 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 |
| 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). | From 12 to 16 weeks |
| Calgary |
| Alberta |
| T2N 2T9 |
| Canada |
| University of Alberta Department of Internal Medicine | Edmonton | Alberta | T6G 2G3 | Canada |
| St. Pauls Hospital | Vancouver | British Columbia | V6Z1Y6 | Canada |
| University of Manitoba Department of Internal Medicine | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Western University | London | Ontario | N6A5C1 | Canada |
| Derived |
| McIntyre CW. Update on Hemodialysis-Induced Multiorgan Ischemia: Brains and Beyond. J Am Soc Nephrol. 2024 May 1;35(5):653-664. doi: 10.1681/ASN.0000000000000299. Epub 2024 Jan 26. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |