Exercise Intensity

NCT07119593 | Active Not Recruiting

• 1 other identifier: 15956
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dialysis; Cardioprotection

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 minutes before the end of HD treatment) at each of the study sessions. Images will be captured in the left lateral position and standard apical 4, and 2 chamber views will be recorded for analysis using automated speckle-training software. (EchoPac, GE Healthcare)

  Week 1 to Week 3

Secondary Outcomes (5)

• Evaluate potential targets of exercise induced cardio protection by evaluating their effects on endothelial function.

  Week 1 to Week 3

• Evaluate whether the increase in exercise intensity leads to a differential modulation of potential cardioprotective mechanisms, by evaluating their effects on hemodynamic responses (Blood Pressure)

  Week 1 to week 3

• Evaluate whether the increase in exercise intensity leads to a differential modulation of potential cardioprotective mechanisms, by evaluating their effects on hemodynamic responses (CV Insight Monitoring)

  Week 1 to Week 3

• Evaluate whether the increase in exercise intensity leads to a differential modulation of potential cardioprotective mechanisms, by evaluating their effects on hemodynamic responses (Finapres)

  Week 1 to Week 3

• Evaluate whether the increase in exercise intensity leads to a differential modulation of potential cardioprotective mechanisms, focusing on blood markers.

  Week 1 to Week 3

Study Arms (3)

Randomization Order 1

OTHER

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.

Other: Intradialytic Cycling

Randomization Order 2

EXPERIMENTAL

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.

Other: Intradialytic Cycling

Randomization 3

EXPERIMENTAL

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.

Other: Intradialytic Cycling

Interventions

Intradialytic Cycling 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; 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 of age
• Willing and able to provide informed consent

You may not qualify if:

• 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

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

Location

Study Officials

• Chris McIntyre, MBBS DM

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

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

Model Details: Open label, randomized, controlled, crossover trial with 3 conditions.

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: August 13, 2025
• Study Start: September 22, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Not Yet Determined
• Access Criteria: Not Yet Determined

Locations

CA (1)