Exercise Preconditioning to Protect Against Dialysis-induced Cardiac Injury

NCT06735378 | Recruiting

• 1 other identifier: 15393
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Hemodialysis; Cardioprotection

Keywords

Cardioprotection; Preconditioning Exercise; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Change in the number of left ventricular segments undergoing a greater than 20% reduction in longitudinal strain as detected by echocardiogram

  An echocardiogram will be completed pre-hemodialysis (HD) treatment and at peak hemodynamic stress (30 min before the end of HD treatment) at each of the four study sessions. Images will be captured in the left lateral position and standard apical 4, 2, and 3 chamber views will be recorded for analysis using automated speckle-tracking software (EchoPac, GE Healthcare)

  week 1 to week 4

Secondary Outcomes (7)

• Evaluate potential targets of preconditioning by exercise-induced cardio protection by focusing on hemodynamics (Blood Pressure)

  week 1 to week 4

• Evaluate potential targets of preconditioning by exercise-induced cardio protection focusing on hemodynamics (CV Insight Monitoring),

  week 1 to week 4

• Evaluate potential targets of preconditioning by exercise-induced cardioprotection, focusing on hemodynamics (Finapres)

  week 1 to week 4

• Evaluate potential targets of preconditioning by exercise-induced cardio protection, focusing on blood markers

  week 1 to week 4

• Evaluate potential targets of preconditioning by exercise-induced cardio protection, focusing on erythrocyte deformability

  week 1 to week 4

Study Arms (2)

Randomization Order 1

EXPERIMENTAL

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.

Other: Intradialytic Cycling

Randomization Order 2

EXPERIMENTAL

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.

Other: Intradialytic Cycling

Interventions

Intradialytic Cycling 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 1; Randomization Order 2

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Study Officials

• Christopher McIntyre

  London Health Sciences Centre Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jarrin Penny, PhD, RN, CNeph (C)

CONTACT

519-685-8500; jarrin.penny@lhsc.on.ca

Kathy Koyle

CONTACT

519-685-8500; kathleen.koyle@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist, Professor of Medicine, Medical Biophysics and Paediatrics

Model Details: Open label, randomized, controlled, crossover trial with 2 conditions and 4 dialysis sessions.

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 16, 2024
• Study Start: January 20, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Not yet determined
• Access Criteria: Not yet determined

Locations

CA (1)