Effect of Intradialytic Exercise on Left Ventricular Diastolic Function in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Evaluation of diastolic dysfunction
研究概览
简要总结
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.
详细描述
Left Ventricular Diastolic Function worsens during the hemodialysis session mainly due to preload effects. However, studies in patients with advanced CKD (pre-dialysis) have shown benefits in diastolic function when subjected to exercise programs. Based on this, implementing a standardized and protocolized exercise regimen during the hemodialysis session could provide cardiovascular benefits, specifically in terms of improving left ventricular diastolic function in this population.
The implementation of intradialytic exercise in the hemodialysis unit of our Institute began in 1994. However, there is no standardized or systematic process for intradialytic exercise.
This leads us to ask the following question: What is the effect of performing systematic intradialytic exercise on the echocardiographic parameters of left ventricular diastolic function in hemodialysis patients?
Methodology
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Echocardiographic image acquisition and analysis were performed by echocardiographers blinded to the study phase (baseline, control, and intervention).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Prevalent patients in hemodiafiltration
Prevalent patients having hemodiafiltration sessions 3 times a week, they used to do intradialytic exercise but this exercise was neither measured, quantified, or supervised, so they were withdrawn from this exercise for 16 weeks and after this time, 16 weeks of structured, measured and supervised intradialytic exercise was introduced.
干预措施: Not exercise (Other)
Prevalent patients in hemodiafiltration
Prevalent patients having hemodiafiltration sessions 3 times a week, they used to do intradialytic exercise but this exercise was neither measured, quantified, or supervised, so they were withdrawn from this exercise for 16 weeks and after this time, 16 weeks of structured, measured and supervised intradialytic exercise was introduced.
干预措施: Exercise during hemodiafiltration session (Other)
结局指标
主要结局
Evaluation of diastolic dysfunction
时间窗: Basal measure (Previous exercise), 3 months after withdrawn of previous exercise during dialysis, 3 months after structured exercise during dialysis
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.
Left Ventricular Diastolic Function Category
时间窗: 16 weeks (end of control period) and 32 weeks (end of intervention)
Classification of left ventricular diastolic function into ordinal grades based on the 2016 ASE/EACVI guidelines. Classification is determined by integrating E/A ratio, average E/e' ratio, indexed left atrial volume (LAVi), and tricuspid regurgitation (TR) velocity. Grade 1 (mild, impaired relaxation) is the least severe; Grade 2 (moderate, pseudonormal filling) represents intermediate severity; Grade 3 (severe, restrictive filling) is the most severe. Grading criteria: Grade 1 (mild - impaired relaxation): E/A \< 0.8, average E/e' ≤ 14, LAVi ≤ 34 ml/m², TR velocity ≤ 2.8 m/s; fewer than 2 positive criteria. Grade 2 (moderate - pseudonormal filling): E/A 0.8-2.0, with ≥ 2 of the following positive: average E/e' \> 14, LAVi \> 34 ml/m², TR velocity \> 2.8 m/s. Grade 3 (severe - restrictive filling): E/A \> 2.0, or E/A 0.8-2.0 with all three criteria positive.
Left Atrial Reservoir Strain (LASr)
时间窗: 16 weeks (end of control period) and 32 weeks (end of intervention)
Peak longitudinal deformation of the left atrium during the reservoir phase measured by 2D speckle tracking echocardiography. Expressed as a percentage (%). Higher values indicate better left atrial reservoir function and, indirectly, less elevation in left ventricular filling pressures.
次要结局
- 6 minute walk test(Basal measure (Previous exercise), 3 months after withdrawn exercise, 3 months after structured exercise)
- VO2 max(3 months after withdrawn of previous exercise, 3 months after structures exercise)
- Left Ventricular Global Longitudinal Strain (GLS)(16 weeks (end of control period) and 32 weeks (end of intervention))
- Automated Left Ventricular Ejection Fraction (AutoLVEF)(16 weeks (end of control period) and 32 weeks (end of intervention))
- Tricuspid Annular Plane Systolic Excursion (TAPSE)(16 weeks (end of control period) and 32 weeks (end of intervention))
- Ratio of Early Mitral Inflow to Mitral Annular Velocity (E/e' Ratio)(16 weeks (end of control period) and 32 weeks (end of intervention period))
- Mitral Inflow E/A Ratio(16 weeks (end of control period) and 32 weeks (end of intervention period))
- Left Atrial Volume Index (LAVi)(16 weeks (end of control period) and 32 weeks (end of intervention period))
- Tricuspid Regurgitation Velocity(16 weeks (end of control period) and 32 weeks (end of intervention period))
- Physical Activity Level (GPPAQ)(16 weeks (end of control period), and 32 weeks (end of intervention))
- Distance Covered in the Six-Minute Walk Test (6MWT)(16 weeks (end of control period) and 32 weeks (end of intervention))
- Peak Workload (Maximal Power Output)(16 weeks (end of control period), and 32 weeks (end of intervention))
- Workload at First Ventilatory Threshold (VT1)(16 weeks (end of control period) and 32 weeks (end of intervention))
- Peak Oxygen Consumption (VO2 Max)(16 weeks (end of control period) and 32 weeks (end of intervention))