Clinical trial NCT06735378: Exercise Preconditioning to Protect Against Dialysis-induced Cardiac Injury
Official title: Exercise Preconditioning to Protect Against Dialysis-induced Cardiac Injury in Hemodialysis Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemodialysis
Cardioprotection
Keywords: Cardioprotection
Preconditioning Exercise
Hemodialysis
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Open label, randomized, controlled, crossover trial with 2 conditions and 4 dialysis sessions.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in the number of left ventricular segments undergoing a greater than 20% reduction in longitudinal strain as detected by echocardiogram
timeFrame: week 1 to week 4
Secondary outcomes:
measure: Evaluate potential targets of preconditioning by exercise-induced cardio protection by focusing on hemodynamics (Blood Pressure)
timeFrame: week 1 to week 4
measure: Evaluate potential targets of preconditioning by exercise-induced cardio protection focusing on hemodynamics (CV Insight Monitoring),
timeFrame: week 1 to week 4
measure: Evaluate potential targets of preconditioning by exercise-induced cardioprotection, focusing on hemodynamics (Finapres)
timeFrame: week 1 to week 4
measure: Evaluate potential targets of preconditioning by exercise-induced cardio protection, focusing on blood markers
timeFrame: week 1 to week 4
measure: Evaluate potential targets of preconditioning by exercise-induced cardio protection, focusing on erythrocyte deformability
timeFrame: week 1 to week 4
measure: Evaluate potential targets of preconditioning by exercise-induced cardio protection, focusing on endothelial function
timeFrame: week 1 to week 4
measure: Evaluate potential targets of preconditioning by exercise-induced cardioprotection, focusing on proteomic analysis.
timeFrame: week 1 to week 4
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute
name: Christopher McIntyre
role: PRINCIPAL_INVESTIGATOR
References: