Exercise Preconditioning to Protect Against Dialysis-induced Cardiac Injury

NCT ID: NCT06735378

Last Updated: 2025-01-22

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-20

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this study is to determine what happens to the heart muscle contraction when people cycle before their hemodialysis treatment. Will pre-dialysis exercise protect the heart from a decrease in pumping of the heart muscle (called stunning) that can happen during hemodialysis. We will study whether pre-dialysis exercise decreases heart stunning, decreases the number and severity of symptoms commonly associated with hemodialysis, and other outcomes

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This will be the first randomized crossover-controlled trial with two experimental conditions assessing the impact of exercise preconditioning in the HD population. If proven effective exercise preconditioning could be developed as a therapeutic option to reduce rates of heart failure in the dialysis population.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemodialysis Cardioprotection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Open label, randomized, controlled, crossover trial with 2 conditions and 4 dialysis sessions.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Randomization Order 1

Participants will be randomized into one of the two groups indicating the order in which they will receive the exercise intervention.

Randomization Order 1 will receive the exercise treatment on the first day of the first week of the study. The other three days without exercise will consist of standard dialysis sessions with study procedures.

Group Type EXPERIMENTAL

Intradialytic Cycling

Intervention Type OTHER

The impact of interdialytic exercise on cardio protection during HD has never been studied. This approach may enhance cardiovascular benefits and overall physical fitness, thereby contributing to better health outcomes in individuals undergoing HD.

Randomization Order 2

Participants will be randomized into one of the two groups indicating the order in which they will receive the exercise intervention.

Randomization Order 2 will receive the exercise treatment on the first day of the fourth week of the study. The other three days without exercise will consist of standard dialysis sessions with study procedures.

Group Type EXPERIMENTAL

Intradialytic Cycling

Intervention Type OTHER

The impact of interdialytic exercise on cardio protection during HD has never been studied. This approach may enhance cardiovascular benefits and overall physical fitness, thereby contributing to better health outcomes in individuals undergoing HD.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intradialytic Cycling

The impact of interdialytic exercise on cardio protection during HD has never been studied. This approach may enhance cardiovascular benefits and overall physical fitness, thereby contributing to better health outcomes in individuals undergoing HD.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* must be on chronic hemodialysis for at least 3 months
* age 18 years or older
* willing and able to provide informed consent
* assessed to be safe and able to exercise by unit HD Nephrologist

Exclusion Criteria

* regular vigorous exercise outside of hemodialysis
* over 79 years of age
* intradialytic exercise \< 3 months
* poor echogenicity
* acute coronary syndrome in the past 3 months
* unstable arrhythmia/angina
* shortness of breath at rest or with minimal activity
* symptomatic hypoglycemia (\>2x/week in the week prior to enrolment)
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chris McIntyre

Nephrologist, Professor of Medicine, Medical Biophysics and Paediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christopher McIntyre

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

London Health Sciences Centre

London, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jarrin Penny, PhD, RN, CNeph (C)

Role: CONTACT

519-685-8500 ext. 58765

Kathy Koyle

Role: CONTACT

519-685-8500 ext. 56214

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15393

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Exercise in Dialysis
NCT05151666 WITHDRAWN NA