Exercise and Cardiac Stunning During HD

NCT04877041 | Active Not Recruiting DMC

• 1 other identifier: HS24857 (B2021:039)
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 6

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.

Conditions

End-stage Kidney Disease; Hemodialysis

Keywords

intradialytic exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Change in post-hemodialysis high sensitivity Troponin T level from baseline to 12 weeks

  Baseline to 12 weeks

• Change in difference between pre-hemodialysis and post-hemodialysis Troponin T from baseline to 12 weeks

  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

  Baseline to 16 weeks

• Change in severity of post-hemodialysis fatigue

  Baseline to 12 weeks

• Change in Symptom Burden

  Baseline to 12 weeks

Study Arms (2)

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

Behavioral: Intradialytic Cycling

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).

Interventions

Intradialytic Cycling BEHAVIORAL

This intervention will consist of intradialytic cycling for 60 minutes 3 times per week for a total of 12 weeks.

Exercise (Intradialytic Cycling)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (6)

University of South Australia

Adelaide, South Australia, 5001, Australia

Location

University of Calgary Cumming School of Medicine Department of Internal Medicine

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta Department of Internal Medicine

Edmonton, Alberta, T6G 2G3, Canada

Location

St. Pauls Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

Location

University of Manitoba Department of Internal Medicine

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Western University

London, Ontario, N6A5C1, Canada

Location

Related Publications (2)

• 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.

  PMID: 41555861 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.

  PMID: 38273436 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clara Bohm, MD, MPH

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts will also be blinded to study group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 7, 2021
• Study Start: March 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5); AU (1)