Intradialytic Exercise and Remote Ischaemic Preconditioning: a Cardioprotective Role ?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 3
- 主要终点
- Change in regional myocardial stunning.
研究概览
简要总结
The aim of this clinical trial is to evaluate whether intermittent exercise and remote ischaemic preconditioning (rIPC) during haemodialysis (HD) can provide cardioprotection in adult patients (aged 20-79 years) undergoing HD for at least 3 months. The main questions to be answered are
Does intermittent exercise or rIPC reduce myocardial stunning during HD? Do these interventions have a beneficial effect on haemorheology, arrhythmias, systemic inflammation and HD efficiency? The investigators will compare three HD sessions: no intervention (HD-CONT), with moderate-intensity intermittent exercise (HD-EX), and with rIPC using cuff inflation (HD-rIPC) to see if HD6EX and HD-rIPC approaches offer enhanced cardioprotection.
Participants will:
Undergo three randomised HD sessions. Participate in 5 blocks of moderate-intensity exercise or rIPC during the HD sessions.
Have cardiac function and biomarkers assessed before, during and after HD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 20 and 79 years.
- •Patients on hemodialysis for more than 3 months.
- •No engagement in regular exercise outside of dialysis.
- •No prior exposure to intradialytic exercise within the past six months.
- •No medical contraindications to physical activity.
- •Life expectancy greater than 6 months.
- •Patients with relative good echogenicity
排除标准
- •Patient is participating in another Category I interventional study, or has participated in another interventional study within the past 3 months
- •The patient is in an exclusion period determined by a previous study
- •The patient is under legal protection or under guardianship or curatorship It turns out to be impossible to give the patient informed information, or the patient refuses to sign the consent
- •Pregnant, parturient or breastfeeding patient
- •Patients with unstable coronary artery disease.
- •Patients with peripheral artery disease (stage III or IV) in the lower limbs.
- •Patients with limb amputation.
- •Patients with musculoskeletal disorders impairing exercise.
- •Presence of a pacemaker, cardiac stimulation device, or implantable cardioverter defibrillator (ICD).
- •History of heart transplant.
- •Patients with uncontrolled hypertension.
- •Refractory anemia.
研究组 & 干预措施
Patients issued from dialysis units (clinic)
Randomised, controlled, crossover, bicentric, single-blind, prospective, open-label, superiority clinical trial comparing 3 dialysis modalities:
Procedure A: Standard dialysis
Procedure B: Dialysis with intradialytic intermittent physical exercise
Procedure C: Dialysis with intradialytic ischaemia/reperfusion sequence of the upper limb
Each subject will realize the 3 sessions in a random order.
干预措施: Remote ischaemic preconditioning (Other)
Patients issued from dialysis units (clinic)
Randomised, controlled, crossover, bicentric, single-blind, prospective, open-label, superiority clinical trial comparing 3 dialysis modalities:
Procedure A: Standard dialysis
Procedure B: Dialysis with intradialytic intermittent physical exercise
Procedure C: Dialysis with intradialytic ischaemia/reperfusion sequence of the upper limb
Each subject will realize the 3 sessions in a random order.
干预措施: Exercise (Other)
Patients issued from dialysis units (clinic)
Randomised, controlled, crossover, bicentric, single-blind, prospective, open-label, superiority clinical trial comparing 3 dialysis modalities:
Procedure A: Standard dialysis
Procedure B: Dialysis with intradialytic intermittent physical exercise
Procedure C: Dialysis with intradialytic ischaemia/reperfusion sequence of the upper limb
Each subject will realize the 3 sessions in a random order.
干预措施: standard dialysis (Other)
结局指标
主要结局
Change in regional myocardial stunning.
时间窗: From enrollment to the end of treatment at 7 weeks
The investigators will use echocardiography to assess the number of left ventricular myocardial segments (using a 18-segment model), that demonstrate a reduction in longitudinal deformation greater than 20% at peak stress during hemodialysis, relative to baseline measurements obtained at the start of the dialysis session. Their aim is to compare changes in regional wall motion abnormalities across three experimental conditions: - Standard hemodialysis (HD-CONT), - Hemodialysis with intradialytic intermittent physical exercise (HD-EX), - Hemodialysis with an intradialytic ischemia/reperfusion sequence applied to the upper limb (HD-RIPC). Patients will participate in all three conditions in a randomized order. A two-week period of standard dialysis will separate the execution of two consecutive sessions.
次要结局
- biological data - characterization of patients - vitamin D(From enrollment)
- biological data - characterization of patients - parathyroid hormone(From enrollment)
- biological data - characterization of patients - creatinine(From enrollment)
- biological data - characterization of patients - creatinine clearance(From enrollment)
- biological data - characterization of patients - urea(From enrollment)
- biological data - characterization of patients - Kt/V(From enrollment)
- biological data - characterization of patients - nPCR(From enrollment)
- biological data - characterization of patients - albumin(From enrollment)
- biological data - characterization of patients - CRP(From enrollment)
- biological data - hematology - complete blood count(From enrollment)
- biological data - hematology - ferritin(From enrollment)
- biological data - hematology - transferrin saturation(From enrollment)
- Hematology - hematocrit(From enrollment to the end of treatment at 7 weeks)
- Hematology - hemoglobin(From enrollment to the end of treatment at 7 weeks)
- biological data - lipidic profile - LDL cholesterol(From enrollment)
- biological data - lipidic profile - HDL cholesterol(From enrollment)
- biological data - lipidic profile - triglycerides(From enrollment)
- Biological data - inflamation - ultra-sensitive c-reactive protein(From enrollment to the end of treatment at 7 weeks)
- Biological data - inflamation - interleukin-6(From enrollment to the end of treatment at 7 weeks)
- Biological data - inflamation - interleukin-10(From enrollment to the end of treatment at 7 weeks)
- Biological data - inflamation - tumor necrosis factor-α(From enrollment to the end of treatment at 7 weeks)
- Hemodynamic parameters - heart rate(From enrollment to the end of treatment at 7 weeks)
- Hemodynamic parameters - stroke volume(From enrollment to the end of treatment at 7 weeks)
- Biological data - endothelial cell activation - intercellular adhesion molecule-1(From enrollment to the end of treatment at 7 weeks)
- Hemorheology - blood viscosity(From enrollment to the end of treatment at 7 weeks)
- Hemorheology - erythrocyte deformability(From enrollment to the end of treatment at 7 weeks)
- Hemorheology - erythrocyte aggregation(From enrollment to the end of treatment at 7 weeks)
- Biological data - fibrinogen(From enrollment to the end of treatment at 7 weeks)
- Biological data - miRNA(From enrollment to the end of treatment at 7 weeks)
- Intraventricular pressure gradient(From enrollment to the end of treatment at 7 weeks)
- Hemodynamic parameters - cardiac output(From enrollment to the end of treatment at 7 weeks)
- Hemodynamic parameters - blood pressure(From enrollment to the end of treatment at 7 weeks)
- Intraventricular flow(From enrollment to the end of treatment at 7 weeks)
- Sublingual microvasculature - proportion of perfused vessels(From enrollment to the end of treatment at 7 weeks)
- Sublingual microvasculature - functional capillary density(From enrollment to the end of treatment at 7 weeks)
- Sublingual microvasculature - De Baker's score(From enrollment to the end of treatment at 7 weeks)
- Sublingual microvasculature - per-capillary microcirculatory flow index(From enrollment to the end of treatment at 7 weeks)
- Sublingual microvasculature - red blood cell mean velocity(From enrollment to the end of treatment at 7 weeks)
- standard echocardiography - LA morphology and function(From enrollment)
- Sublingual microvasculature - total vessel density(From enrollment to the end of treatment at 7 weeks)
- Biological data - endothelial cell activation - vascular cell adhesion molecule-1(From enrollment to the end of treatment at 7 weeks)
- Biological data - endothelial cell activation - endothelin(From enrollment to the end of treatment at 7 weeks)
- standard echocardiography - LV volumes(From enrollment)
- Biological data - endothelial cell activation - proendothelin(From enrollment to the end of treatment at 7 weeks)
- biological data - insulin resistance - glucose(From enrollment)
- standard echocardiography - LV global diastolic function - E wave(From enrollment to the end of treatment at 7 weeks)
- standard echocardiography - LV global diastolic function - tricuspid regurgitation(From enrollment)
- standard echocardiography - RV systolic function - TAPSE(From enrollment)
- standard echocardiography - RV morphology - areas(From enrollment)
- standard echocardiography - RV global diastolic function - Et wave(From enrollment)
- biological data - insulin resistance - glycated hemoglobin(From enrollment)
- biological data - insulin resistance - insulin(From enrollment)
- Biological data - uraemic toxins - beta2-microglobulin(From enrollment to the end of treatment at 7 weeks)
- Biological data - uraemic toxins - Indoxyl sulfate(From enrollment to the end of treatment at 7 weeks)
- Biological data - uraemic toxins - p-Cresyl sulfate(From enrollment to the end of treatment at 7 weeks)
- Biological data - uraemic toxins - myoglobin(From enrollment to the end of treatment at 7 weeks)
- Biological data - uraemic toxins - free light chains(From enrollment to the end of treatment at 7 weeks)
- Biological data - cardiac biomarkers - NT-pro-BNP(From enrollment to the end of treatment at 7 weeks)
- Biological data - cardiac biomarkers - BNP level(From enrollment to the end of treatment at 7 weeks)
- Biological data - cardiac biomarkers - cardiac troponin T(From enrollment to the end of treatment at 7 weeks)
- Biological data - cardiac biomarkers - sST2(From enrollment to the end of treatment at 7 weeks)
- biological data - characterization of patients - sodium(From enrollment)
- biological data - characterization of patients - potassium(From enrollment)
- biological data - characterization of patients - calcium(From enrollment)
- biological data - characterization of patients - phosphate(From enrollment)
- Strains - LV(From enrollment to the end of treatment at 7 weeks)
- Strains - RV(From enrollment to the end of treatment at 7 weeks)
- Strains - LA(From enrollment to the end of treatment at 7 weeks)
- standard echocardiography - LV morphology - diameter(From enrollment)
- standard echocardiography - LV morphology - wal thicknessess(From enrollment)
- standard echocardiography - RV morphology - diameters(From enrollment)
- standard echocardiography - LV global systolic function(From enrollment)
- standard echocardiography - LV morphology - mass(From enrollment)
- Myocardial work - global myocardial work(From enrollment to the end of treatment at 7 weeks)
- Myocardial work - global constructive work(From enrollment to the end of treatment at 7 weeks)
- Myocardial work - global wasted work(From enrollment to the end of treatment at 7 weeks)
- Myocardial work - global work efficiency(From enrollment to the end of treatment at 7 weeks)
- standard echocardiography - LV global diastolic function - A wave(From enrollment to the end of treatment at 7 weeks)
- standard echocardiography - RV systolic function(From enrollment)
- standard echocardiography - RV global diastolic function(From enrollment)
- standard echocardiography - tissue Doppler imaging - LV e'(From enrollment)
- standard echocardiography - tissue Doppler imaging - LV a'(From enrollment)
- standard echocardiography - tissue Doppler imaging - LV s'(From enrollment)
- standard echocardiography - tissue Doppler imaging - RV e'(From enrollment)
- standard echocardiography - tissue Doppler imaging- RV a'(From enrollment)
- standard echocardiography - tissue Doppler imaging - RV s'(From enrollment)
- standard echocardiography - RV morphology and function - diameters(From enrollment)
- standard echocardiography - RV global diastolic function - Et/At ratio(From enrollment)
- standard echocardiography - LV global diastolic function - E/A(From enrollment to the end of treatment at 7 weeks)
- standard echocardiography - diastolic function - LV E/e'(From enrollment)
- standard echocardiography - diastolic function - RV Et/e'(From enrollment)