Exercise and Cardiac Stunning During HD

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

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; End-stage Kidney Disease
• Intervention / Treatment: Behavioral: Intradialytic Cycling

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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5001
      • University of South Australia
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • University of Calgary Cumming School of Medicine Department of Internal Medicine
    • Edmonton, Alberta, Canada, T6G 2G3
      • University of Alberta Department of Internal Medicine
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z1Y6
      • St. Pauls Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • University of Manitoba Department of Internal Medicine
  • Ontario
    • London, Ontario, Canada, N6A5C1
      • Western University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / 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).

What is the study measuring?

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 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
Change in Cognitive Function	Change in cognitive function score measured by Cambridge Brain Science testing	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
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 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 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

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Clara Bohm, MD, MPH, University of Manitoba

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): January 14, 2026
• Study Completion (Actual): February 11, 2026

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: intradialytic exercise
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic
• Other Study ID Numbers: HS24857 (B2021:039)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No