Exercise Intensity

NCT ID: NCT07119593

Last Updated: 2025-09-26

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

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-22

Study Completion Date

2025-12-31

Brief Summary

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Patients receiving regular hemodialysis (HD) treatments are at a higher risk of cardiovascular events and death as HD can cause a decrease in the pumping of the heart during treatment called 'stunning'. Intradialytic exercise has emerged as a safe and effective non-drug approach to improve cardiovascular health and is now recommended for patients undergoing HD. It is currently advised that HD patients engage in at least 30 minutes of moderate to vigorous exercise three times per week. This study will evaluate the impact of exercise intensity in the HD population and determine if high impact exercise can offer better protection to the heart against HD-induced myocardial stunning.

Detailed Description

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This will be the first randomized, cross-controlled trial evaluating the impact of exercise intensity in the HD population. If the efficacy of cardiovascular protection is proven, it could be developed as a therapeutic option in the dialysis population.

Conditions

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Dialysis Cardioprotection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Open label, randomized, controlled, crossover trial with 3 conditions.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Randomization Order 1

Participants will be randomized into one of the three conditions indicating the order in which they will receive the exercise intervention. Randomization Order 1 will receive control (no exercise) week one. Week 2 the participant will have a moderate intensity exercise treatment and week three the participant will have a high intensity exercise treatment. All sessions (i.e. HD-Cont, HD-Mod and HD-High) will be performed on one of the patient's three days of weekly dialysis. Each patient will consistently perform all sessions on the same day of dialysis throughout the study. The three sessions will be separate by at least one week to avoid potential carryover effects.

Group Type OTHER

Intradialytic Cycling

Intervention Type OTHER

Intradialytic exercise has emerged as a safe and effective non-drug therapeutic approach to improve cardiovascular health and is now recommended for people undergoing hemodialysis treatment. Administration of a higher intensity exercise could offer better cardio-protective mechanisms and if the efficacy of cardiovascular protection is proven, it could be developed as a therapeutic option in the dialysis population.

Randomization Order 2

Participants will be randomized into one of the three conditions indicating the order in which they will receive the exercise intervention. Randomization Order 2 will receive moderate intensity exercise week one. Week 2 the participant will have high intensity exercise and week three the participant will have control (no exercise). All sessions (i.e. HD-Cont, HD-Mod and HD-High) will be performed on one of the patient's three days of weekly dialysis. Each patient will consistently perform all sessions on the same day of dialysis throughout the study. The three sessions will be separate by at least one week to avoid potential carryover effects.

Group Type EXPERIMENTAL

Intradialytic Cycling

Intervention Type OTHER

Intradialytic exercise has emerged as a safe and effective non-drug therapeutic approach to improve cardiovascular health and is now recommended for people undergoing hemodialysis treatment. Administration of a higher intensity exercise could offer better cardio-protective mechanisms and if the efficacy of cardiovascular protection is proven, it could be developed as a therapeutic option in the dialysis population.

Randomization 3

Participants will be randomized into one of the three conditions indicating the order in which they will receive the exercise intervention. Randomization Order 3 will receive high intensity exercise week one. Week 2 the participant will have control (no exercise) and week three the participant will have a moderate intensity exercise treatment. All sessions (i.e. HD-Cont, HD-Mod and HD-High) will be performed on one of the patient's three days of weekly dialysis. Each patient will consistently perform all sessions on the same day of dialysis throughout the study. The three sessions will be separate by at least one week to avoid potential carryover effects.

Group Type EXPERIMENTAL

Intradialytic Cycling

Intervention Type OTHER

Intradialytic exercise has emerged as a safe and effective non-drug therapeutic approach to improve cardiovascular health and is now recommended for people undergoing hemodialysis treatment. Administration of a higher intensity exercise could offer better cardio-protective mechanisms and if the efficacy of cardiovascular protection is proven, it could be developed as a therapeutic option in the dialysis population.

Interventions

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Intradialytic Cycling

Intradialytic exercise has emerged as a safe and effective non-drug therapeutic approach to improve cardiovascular health and is now recommended for people undergoing hemodialysis treatment. Administration of a higher intensity exercise could offer better cardio-protective mechanisms and if the efficacy of cardiovascular protection is proven, it could be developed as a therapeutic option in the dialysis population.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Must be on chronic hemodialysis for at least 3 months
* Age ≥ 18 years of age
* Willing and able to provide informed consent

Exclusion Criteria

* Regular vigorous exercise outside hemodialysis
* \> 79 years of age
* Intradialytic exercise in the past 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)
* Symptomatic peripheral arterial disease
* Unable or deemed unsafe to exercise for any reason
* Severe musculoskeletal or orthopedic conditions
* Aortic stenosis
* Hypertrophic cardiopathy
* Severe pulmonary hypertension
* Symptomatic hypertension
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Chris McIntyre

Nephrologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chris McIntyre, MBBS DM

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jarrin Penny, PhD, RN, CNeph (C)

Role: CONTACT

519-685-8500 ext. 58765

Kathy Koyle

Role: CONTACT

519-685-8500 ext. 56214

Facility Contacts

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Jarrin Penny, PhD RN

Role: primary

519-685-8500 ext. x 58765

kathy Koyle

Role: backup

519-685-8500 ext. x 56214

Other Identifiers

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15956

Identifier Type: -

Identifier Source: org_study_id

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