N/A
N=30
Effect of Intradialytic Exercise on Left Ventricular Diastolic Function in Hemodialysis Patients
Renal Dialysis · Hemodiafiltration · Diastolic Dysfunction · Kidney Failure · Quality of Life
Bottom Line
View on ClinicalTrials.gov: NCT06584734 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Left Ventricular Diastolic Function Category — 15; 15; 5; 5 Participants — p=0.06
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Not exercise (Other); Exercise during hemodiafiltration session (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Left Ventricular Diastolic Function Category |
15; 15; 5; 5; 1; 1 | 0.06 |
| PRIMARY Left Atrial Reservoir Strain (LASr) |
26.2; 30.4 | 0.05 |
| SECONDARY Left Ventricular Global Longitudinal Strain (GLS) |
-15.5; -17.4 | 0.002 sig |
| SECONDARY Automated Left Ventricular Ejection Fraction (AutoLVEF) |
56.8; 59.5 | 0.006 sig |
| SECONDARY Tricuspid Annular Plane Systolic Excursion (TAPSE) |
20.6; 22.2 | 0.04 sig |
| SECONDARY Ratio of Early Mitral Inflow to Mitral Annular Velocity (E/e' Ratio) |
9.98; 10.2 | 0.775 |
| SECONDARY Mitral Inflow E/A Ratio |
1.15; 1.23 | 0.478 |
| SECONDARY Left Atrial Volume Index (LAVi) |
30.8; 30.1 | 0.660 |
| SECONDARY Tricuspid Regurgitation Velocity |
2.95; 2.80 | 0.269 |
| SECONDARY Physical Activity Level (GPPAQ) |
2; 2; 6; 1; 2; 5 | 0.51 |
| SECONDARY Distance Covered in the Six-Minute Walk Test (6MWT) |
475; 492 | 0.21 |
| SECONDARY Peak Workload (Maximal Power Output) |
72.9; 95.2 | 0.01 sig |
| SECONDARY Workload at First Ventilatory Threshold (VT1) |
33.8; 42.6 | 0.003 sig |
| SECONDARY Peak Oxygen Consumption (VO2 Max) |
17.5; 19.8 | 0.24 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06584734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.