London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Location status: Recruiting
NCT Number: NCT06735378
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
Interested in participating?
Request Info18 year–79 year
All sexes
Interventional
Not applicable
London, Ontario, N6A 5W9, Canada
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: week 1 to week 4
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)
Time frame: week 1 to week 4
Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and mean arterial pressure (MAP) will be measured using an automated blood pressure monitor integrated into the dialysis machine. Values will be monitored throughout each study.
Time frame: week 1 to week 4
The CV Insight contact device is a non-invasive continuous hemodynamic real time monitoring system used to assess cardiovascular and respiratory status using percutaneous photoplethysmography. The device will be attached to the right of the patient's forehead midline, approximately 2.5 cm above the level of the nose pre-dialysis and will remain intact until the patient is disconnected from the dialysis machine at each study session. Once attached, baseline recording will be obtained, and hemodynamic data will be continuously captured.
Time frame: week 1 to week 4
The Finometer utilizes a finger-cuff method to detect beat-to-beat changes in digital arterial diameter using an infrared photoplethysmography. The time-averaged data is subsequently downloaded to a computer-based analysis program for analysis. The finger-cuff will be placed on the participant's index finger at each study visit and will remain in place throughout the entire study visit
Time frame: week 1 to week 4
Blood samples will be collected from the participants dialysis access. Before HD and at peak-stress of each study session, will be collected for biochemistry, proteomic analysis and translational approach.
Time frame: week 1 to week 4
Blood samples will be collected from the participants dialysis access. Before HD and at peak-stress of each study session for analysis of erythrocyte deformability which indicates microcirculation efficiency
Time frame: week 1 to week 4
Endothelial function is assessed by measuring the dilatory response of the brachial artery to increased blood flow generated by reactive hyperemia in the downstream forearm. At each study session participants are placed in the supine position and the brachial artery of the non-dominant arm, or the non-distended arm is scanned in longitudinal section using a 12 MHz linear transducer connected to a Vivid Q echograph (GE, USA) supplemented by an electrocardiogram (ECG).
Time frame: week 1 to week 4
Proteomic alterations in plasma are important in the inflammatory response to ischemia-reperfusion (IR) injury. Blood Samples (plasma) will be collected pre and peak dialysis at each study session for the analysis of changes induced by exercise preconditioning, with the aim of identifying new potential targets for cardio protection.
Contact information is provided by the study sponsor or research team.
Jarrin Penny, PhD, RN, CNeph (C)
CONTACT
519-685-8500 ext. 58765
Kathy Koyle
CONTACT
519-685-8500 ext. 56214
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Other
Exercise Preconditioning to Protect Against Dialysis-induced Cardiac Injury in Hemodialysis Patients: a Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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