Effect of Intradialytic Exercise on Left Ventricular Diastolic Function in Hemodialysis Patients
NCT Number: NCT06584734
Acronym: EXE-HDF
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Renal Dialysis|Hemodiafiltration|Diastolic Dysfunction|Kidney Failure|Resistance Training|Quality of Life
Interventions: OTHER: Not exercise|OTHER: Exercise during hemodiafiltration session
Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 41
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-17
Completion Date: 2024-10-30
Locations: Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, 14080, Mexico

Summary:
Introduction: Cardiovascular diseases are the leading cause of morbidity and mortality in hemodialysis patients, primarily due to structural cardiac changes that lead to diastolic dysfunction. Furthermore, this population has a high prevalence of sedentary behavior and increased mortality associated with it. Recent studies have implemented exercise regimens in the chronic kidney disease population, demonstrating improvements in various parameters related to cardiovascular disease.

Objectives: To evaluate the effect of implementing systematic intradialytic exercise on left ventricular diastolic function.

Materials and Methods: This is a quasi-experimental study (before-and-after type) that will be conducted in two phases. In the first phase (rest), both incident and prevalent hemodialysis patients will receive treatment for 3 months. A baseline echocardiogram will be performed and then repeated at the end of the first phase to determine left ventricular diastolic function parameters. The second phase of the study (intradialytic exercise) will take place during the following 3 months, with an echocardiogram performed at the beginning and end of this phase. Systematic, prescribed, and supervised intradialytic aerobic exercise (intradialytic pedaling) will be implemented. Additionally, a 6-minute walk test and a validated physical activity questionnaire will be administered monthly during both phases of the study.

Primary Outcome Measures: Evaluation of diastolic dysfunction, Diastolic function will be assessed following the 2016 guidelines from the American and European Societies of Echocardiography. The study will be performed by certified cardiologists using a Vivid Q GE ultrasound machine with a 3.5 MHz transducer. Key measurements include early (E wave) and late (A wave) transmitral flow velocities, E/A ratio, and tissue Doppler imaging (TDI) to determine septal and lateral e' waves. The E/e' ratio will be calculated. Left atrial (LA) volume will be measured and indexed to body surface area. Tricuspid regurgitation (TR) velocity will be assessed using continuous Doppler. Based on these parameters, diastolic dysfunction will be classified into grades 1, 2, 3, or indeterminate, according to current guidelines, considering whether the ejection fraction (EF) is reduced or preserved. The determination of left atrial strain will be performed using tissue Doppler imaging in an apical 4-chamber view with the speckle tracking method., Basal measure (Previous exercise), 3 months after withdrawn of previous exercise during dialysis, 3 months after structured exercise during dialysis
Secondary Outcome Measures: 6 minute walk test, The test will be performed on the first day of the hemodialysis session (Monday or Tuesday) before the dialysis session, with a frequency of every 4 weeks. The test will be conducted based on the guidelines of the American and European Thoracic Societies by two medical interns, who are trained to perform the test, Basal measure (Previous exercise), 3 months after withdrawn exercise, 3 months after structured exercise|VO2 max, Cardiopulmonary exercise test with cycle ergometer will be made by a specialized sports physician to the patients to asses training zones, in this test we will measure any improvement on VO2max (ml/min/kg), 3 months after withdrawn of previous exercise, 3 months after structures exercise