Trial Summary
What is the purpose of this trial?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
Eligibility Criteria
This trial is for individuals who are undergoing hemodialysis, a treatment for kidney failure. Participants should be willing to exercise before their dialysis sessions. Specific eligibility criteria are not provided, but typically include factors like age range, overall health status, and the absence of conditions that could interfere with the study or pose risks.Inclusion Criteria
I am 18 years old or older.
I have been on hemodialysis for at least 3 months.
Exclusion Criteria
I am over 79 years old.
I have had a heart attack or other heart issue in the last 3 months.
I do not have uncontrolled heart rhythm problems or chest pain.
I experience shortness of breath with little to no activity.
Treatment Details
The study is testing if cycling before hemodialysis can protect the heart from damage during treatment. It aims to see whether this 'preconditioning' exercise can prevent a decrease in heart muscle pumping ability and reduce symptoms related to hemodialysis.
2Treatment groups
Experimental Treatment
Group I: Randomization Order 2Experimental Treatment1 Intervention
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.
Group II: Randomization Order 1Experimental Treatment1 Intervention
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.
Intradialytic Cycling is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Intradialytic Cycling for:
- Improvement of physical function in hemodialysis patients
- Enhancement of cardiovascular health in patients undergoing hemodialysis
🇺🇸 Approved in United States as Intradialytic Cycling for:
- Reduction of hemodialysis-induced myocardial stunning
- Improvement of exercise capacity in adult hemodialysis patients
🇨🇦 Approved in Canada as Intradialytic Cycling for:
- Enhancement of physical function and quality of life in hemodialysis patients
Find a clinic near you
Research locations nearbySelect from list below to view details:
London Health Sciences CentreLondon, Canada
Loading ...
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph'sLead Sponsor