Effect of Intradialytic Exercise on Left Ventricular Diastolic Function in Hemodialysis Patients (NCT06584734) | Clinical Trial Compass
CompletedNot Applicable
Effect of Intradialytic Exercise on Left Ventricular Diastolic Function in Hemodialysis Patients
Mexico30 participantsStarted 2023-09-17
Plain-language summary
Introduction: Cardiovascular disease is the leading cause of morbidity and mortality in patients undergoing hemodialysis, largely due to structural cardiac changes associated with left ventricular diastolic dysfunction. In addition, this population has a high prevalence of sedentary behavior, which has been associated with increased mortality. Recent studies in patients with chronic kidney disease have shown that structured exercise interventions improve several parameters related to cardiovascular health.
Objectives: To evaluate the effect of implementing systematic intradialytic exercise on left ventricular diastolic function.
Materials and Methods: This will be a quasi-experimental before-and-after study conducted in two phases. During the first phase (control), prevalent hemodialysis patients will receive standard treatment for 16 weeks. Transthoracic echocardiography will be performed at baseline and repeated at the end of this phase to assess left ventricular diastolic function parameters. During the second phase (intradialytic exercise), participants will undergo a 16-week supervised and prescribed intradialytic aerobic exercise program consisting of intradialytic cycling. Exercise intensity will be individualized according to cardiopulmonary exercise testing (CPET), which will be performed at the beginning and end of this phase. A final echocardiogram will be obtained at the end of the intervention phase. In addition, a 6-minute walk test and a validated physical activity questionnaire will be administered monthly throughout both phases of the study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults ≥ 18 years
* Both genders
* Patients currently enrolled in the hemodialysis program at the National Institute of Cardiology unit
* Patients on hemodialysis for at least 3 months prior to enrollment
* Echocardiographic evidence of left ventricular diastolic dysfunction
* Patients with sufficient cognitive ability to understand and follow study instructions
* Patients with a good echocardiographic window that allows for the determination of parameters evaluating left ventricular diastolic function
* Patients capable of performing stationary cycling during hemodialysis sessions
* Patients who agree to participate and provide written informed consent prior to enrollment
Exclusion Criteria:
* Patients who have had a major cardiovascular event (MI, stroke) in the 3 months prior to the start of the study
* Patients who have visited the emergency room for symptoms of decompensated heart failure in the 3 months prior to the start of the study
* Patients diagnosed with atrial fibrillation and/or atrial flutter
* Patients with a mechanical mitral valve prosthesis
* Patients with orthopedic conditions or physical limitations that preclude lower-limb stationary cycling
* Pregnant women
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Left Ventricular Diastolic Function Category
Timeframe: 16 weeks (end of control period) and 32 weeks (end of intervention)
2
Left Atrial Reservoir Strain (LASr)
Timeframe: 16 weeks (end of control period) and 32 weeks (end of intervention)
Trial details
NCT IDNCT06584734
SponsorInstituto Nacional de Cardiologia Ignacio Chavez