Exercise Intensity

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

Status: Enrolling

Conditions: Dialysis; Cardioprotection

Treatments: Other: Intradialytic Cycling

Study type: Interventional

Funder types: Other

Identifiers

NCT07119593

15956

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Randomization Order 1

Other group

Description:

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.

Treatment:

Other: Intradialytic Cycling

Randomization Order 2

Experimental group

Description:

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.

Treatment:

Other: Intradialytic Cycling

Randomization 3

Experimental group

Description:

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.

Treatment:

Other: Intradialytic Cycling