Exercise and Cardiac Stunning During HD

NCT ID: NCT04877041

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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End-stage Kidney Disease Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Data analysts will also be blinded to study group

Study Groups

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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

Group Type EXPERIMENTAL

Intradialytic Cycling

Intervention Type BEHAVIORAL

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

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intradialytic Cycling

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clara Bohm, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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University of South Australia

Adelaide, South Australia, Australia

Site Status

University of Calgary Cumming School of Medicine Department of Internal Medicine

Calgary, Alberta, Canada

Site Status

University of Alberta Department of Internal Medicine

Edmonton, Alberta, Canada

Site Status

St. Pauls Hospital

Vancouver, British Columbia, Canada

Site Status

University of Manitoba Department of Internal Medicine

Winnipeg, Manitoba, Canada

Site Status

Western University

London, Ontario, Canada

Site Status

Countries

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Australia Canada

References

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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.

Reference Type DERIVED
PMID: 38273436 (View on PubMed)

Other Identifiers

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HS24857 (B2021:039)

Identifier Type: -

Identifier Source: org_study_id

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