NCT07269379招募中不适用
Intradialytic Exercise With Blood Flow Restriction by Vascular Occlusion: A New Strategy for Cardioprotection in Hemodialysis Patients
University of Avignon3 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年11月6日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 3
- 主要终点
- Change in the number of regional wall motion abnormalities (RWMAs)
研究概览
简要总结
The main objective is to evaluate in hemodialysis patients the effects of two intradialytic rehabilitation programs based on physical exercise, with or without the application of blood flow restriction, on myocardial stunning and morpho-functional cardiac remodelling, compared with usual care (i.e., dialysis without exercise). In addition, the investigators will also assess the acute effects (i.e., a single session for each condition) of physical exercise, with or without blood flow restriction, on myocardial stunning at the end of dialysis.
In comparison with a conventional exercise program, the combination of physical exercise with blood flow restriction, which synergistically and additively activates intramuscular signalling pathways related to both exercise and ischaemia, is hypothesised to result in:
- A greater intradialytic cardioprotection, as demonstrated by a greater reduction in myocardial stunning at the end of dialysis (both in acute and chronic applications), with underlying mechanisms involving systemic and neuro-humoral pathways;
- Significant improvements in morpho-functional cardiac remodelling, attenuation of arrhythmic disturbances, and enhancement of aerobic capacity, muscle strength, and muscle mass-effects not observed with exercise alone without blood flow restriction, considering the low exercise intensity used in the current rehabilitation program (chronic application only).
This is a three-arm randomised clinical trial with parallel groups: standard hemodialysis (HD-CONTChro), a rehabilitation program with intradialytic exercise without vascular occlusion (HD-EXChro), and a rehabilitation program with intradialytic exercise with vascular occlusion (HD-BFREChro), with a 1:1:1 allocation ratio.
To investigate the acute effects of the interventions, all patients will undergo, in a randomized order, one session of each of the three dialysis modalities-standard hemodialysis (HD-CONTacute), hemodialysis with exercise without vascular restriction (HD-EXacute), and hemodialysis with exercise with vascular restriction (HD-BFREacute)-prior to initiation of the chronic phase of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
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.
- •Patients stratified as high risk for deep venous thrombosis
结局指标
主要结局
Change in the number of regional wall motion abnormalities (RWMAs)
时间窗: From enrollment to the end of the program at 19 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 the change in regional wall motion abnormalities (RWMAs) at peak stress of dialysis (i.e. 30 min before its end), in a standard HD, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). For the acute phase, the investigators will compare the number of RWMAs measured 30min before the end of each HD session between the 3 conditions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)
次要结局
- Change in LV longitudinal strains(From enrollment to the end of the program at 19 weeks)
- Change in RV longitudinal strains(From enrollment to the end of the program at 19 weeks)
- Change in LA longitudinal strains(From enrollment to the end of the program at 19 weeks)
- Change in global constructive work(From enrollment to the end of the program at 19 weeks)
- Change in global wasted work(From enrollment to the end of the program at 19 weeks)
- Change in global work efficiency(From enrollment to the end of the program at 19 weeks)
- Change in global myocardial work(From enrollment to the end of the program at 19 weeks)
- Change in left intraventricular pressure gradient(From enrollment to the end of the program at 19 weeks)
- Change in LV diameter(From enrollment to the end of the program at 19 weeks)
- Change in LV wall thicknessess(From enrollment to the end of the program at 19 weeks)
- Change in LV volumes(From enrollment to the end of the program at 19 weeks)
- Change in LV mass(From enrollment to the end of the program at 19 weeks)
- Change in LV global systolic function (ejection fraction)(From enrollment to the end of the program at 19 weeks)
- Change in LV s' wave(From enrollment to the end of the program at 19 weeks)
- Change in LV e' wave(From enrollment to the end of the program at 19 weeks)
- Change in LV a' wave(From enrollment to the end of the program at 19 weeks)
- Change in LV E wave (global diastolic function)(From enrollment to the end of the program at 19 weeks)
- Change in LV A wave (global diastolic function)(From enrollment to the end of the program at 19 weeks)
- Change in RV areas(From enrollment to the end of the program at 19 weeks)
- Change in LV E/e'(From enrollment to the end of the program at 19 weeks)
- Change in RV systolic function(From enrollment to the end of the program at 19 weeks)
- Change in RV systolic function 2(From enrollment to the end of the program at 19 weeks)
- Change in RV diameter(From enrollment to the end of the program at 19 weeks)
- Change in RV Et wave(From enrollment to the end of the program at 19 weeks)
- Change in RV At wave(From enrollment to the end of the program at 19 weeks)
- Change in RV Et/At ratio(From enrollment to the end of the program at 19 weeks)
- Change in RV e'(From enrollment to the end of the program at 19 weeks)
- Change in RV a'(From enrollment to the end of the program at 19 weeks)
- Change in RV s'(From enrollment to the end of the program at 19 weeks)
- Change in tricuspid regurgitation(From enrollment to the end of the program at 19 weeks)
- Change in RV Et/e'(From enrollment to the end of the program at 19 weeks)
- Change in LA morphology and function(From enrollment to the end of the program at 19 weeks)
- Change in blood pressure(From enrollment to the end of the program at 19 weeks)
- Change in cardiac output(From enrollment to the end of the program at 19 weeks)
- Change in stroke volume(From enrollment to the end of the program at 19 weeks)
- Change in heart rate(From enrollment to the end of the program at 19 weeks)
- Change in blood level of sodium(From enrollment to the end of the program at 19 weeks)
- Change in blood level of potassium(From enrollment to the end of the program at 19 weeks)
- Change in blood level of calcium(From enrollment to the end of the program at 19 weeks)
- Change in blood level of phosphate(From enrollment to the end of the program at 19 weeks)
- Change in blood level of vitamin D(From enrollment to the end of the program at 19 weeks)
- Change in blood level of parathyroid hormone(From enrollment to the end of the program at 19 weeks)
- Change in blood level of creatinine(From enrollment to the end of the program at 19 weeks)
- Change in creatinine clearance(From enrollment to the end of the program at 19 weeks)
- Change in blood level of urea(From enrollment to the end of the program at 19 weeks)
- Change in serum level of albumin(From enrollment to the end of the program at 19 weeks)
- Change in normalized proteïn catabolic rate(From enrollment to the end of the program at 19 weeks)
- Change in Kt/V(From enrollment to the end of the program at 19 weeks)
- Change in serum level of c-reactive protein(From enrollment to the end of the program at 19 weeks)
- Change in complete blood count(From enrollment to the end of the program at 19 weeks)
- Change in serum level of ferritin(From enrollment to the end of the program at 19 weeks)
- Change in transferrin saturation(From enrollment to the end of the program at 19 weeks)
- Change in LDL cholesterol(From enrollment to the end of the program at 19 weeks)
- Change in HDL cholesterol(From enrollment to the end of the program at 19 weeks)
- Change in triglyceride level(From enrollment to the end of the program at 19 weeks)
- Change in hematocrit(From enrollment to the end of the program at 19 weeks)
- Change in hemoglobin level(From enrollment to the end of the program at 19 weeks)
- Change in interleukin-6 level(From enrollment to the end of the program at 19 weeks)
- Change in interleukin-10 level(From enrollment to the end of the program at 19 weeks)
- Change in tumor necrosis factor-α level(From enrollment to the end of the program at 19 weeks)
- Change in ultra-sensitive c-reactive protein level(From enrollment to the end of the program at 19 weeks)
- Change in intercellular adhesion molecule-1 level(From enrollment to the end of the program at 19 weeks)
- Change in vascular cell adhesion molecule-1 level(From enrollment to the end of the program at 19 weeks)
- Change in endothelin level(From enrollment to the end of the program at 19 weeks)
- Change in proendothelin level(From enrollment to the end of the program at 19 weeks)
- Change in NT-pro-BNP level(From enrollment to the end of the program at 19 weeks)
- Change in BNP level(From enrollment to the end of the program at 19 weeks)
- Change in cardiac troponin T level(From enrollment to the end of the program at 19 weeks)
- Change in levels of soluble ST2(From enrollment to the end of the program at 19 weeks)
- Change in beta2-microglobulin level(From enrollment to the end of the program at 19 weeks)
- Change in indoxyl sulfate level(From enrollment to the end of the program at 19 weeks)
- Change in p-Cresyl sulfate level(From enrollment to the end of the program at 19 weeks)
- Change in myoglobin level(From enrollment to the end of the program at 19 weeks)
- Change in free light chains(From enrollment to the end of the program at 19 weeks)
- Change in whole blood viscosity(From enrollment to the end of the program at 19 weeks)
- Change in erythrocyte deformability(From enrollment to the end of the program at 19 weeks)
- Change in erythrocyte aggregation(From enrollment to the end of the program at 19 weeks)
- Change in fibrinogen level(From enrollment to the end of the program at 19 weeks)
- Change in miRNA(From enrollment to the end of the program at 19 weeks)
研究者
研究点 (3)
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