Evaluation of Electrostimulation Program During Dialysis Sessions in Chronic Renal Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 22
- 主要终点
- difference between distances during the 6 minutes walk test before and after the 3 month program between the stimulated and the non stimulated group
研究概览
简要总结
Sport improves quality of life and health, decreasing cardiovascular risks and increasing effort tolerance. Chronic renal failure (CRF) induces many clinical and biological complications leading to less effort tolerance (strength and endurance). Renal failure patients got also many cardiovascular risks : sedentarily lifestyle, hypertension (HTA), diabetes, neuropathies, bone disorders, depression and sedentarity due to dialysis sessions. Moreover, dialysis sessions three times a week induce the spiral of deconditioning. In order to counteract this, sport should be encourage in this specific hemodialysis population.
The aim of this study is to evaluate electrostimulation program during dialysis sessions for 3 months. Evaluation will be done using the Test of 6-minute walk (6MWT).
Secondary aims will be evaluated:
- Muscular strength and quadriceps diameter
- Equilibrium
- Quality of life.
- Strength developed during maximal exercise test in a subgroup (patient undergoing dialysis in Rennes center, about 40% of the total population)
- Nutritional intakes (quantitative and qualitative evaluation)
详细描述
The primary outcome is the difference between distances during the 6 minutes walk test before and after the 3 month program between the stimulated and the non stimulated group.
The secondary outcomes will be evaluated by maximum strength developed during the ergometry, limited by symptoms; maximal charge during muscular test; quadricipital diameter; time for the " Timed up and go " test; quality of life scores. All those scores will be evaluated in the control and stimulated groups before and after the 3 month period.
This is an open randomized controlled study. Tests will be done by an investigator unaware of the stimulation group. The study is designed to detect a difference of 61 m (+/- 80 m) (6MWT) before and after stimulation in the stimulated group and 0 in the control group. This difference has been based on a pilot study with ergocycle in the same population and on literature in other populations (chronic respiratory failure or post cardiac surgery). We estimated that 70 patients would need to be enrolled in each group to provide 90% statistical power with a bilateral test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients, > 18 y/o, undergoing chronic hemodialysis since more than 3 months.
- •Physical activity score (Voorrips test) <9.4
- •Patients clinically and hemodynamically stable.
- •No major drug or dialysis treatment changes since 2 weeks
- •Written consent signed.
排除标准
- •Relative or absolute contraindication to ergotest (ACC/AHA, 2002) and/or physical reentrainment.
- •Incapacity to practice the Test of 6-minute walk (6MWT) or ergotest
- •Clinical instability during hemodialysis sessions.
- •Hb<9g/dl despite medical treatment ; PAS ≥180 mmHg et/ou PAD ≥110 mmHg despite medical treatment ;
- •Cardiac pace maker or defibrillator ;
- •Pregnancy ;
- •Recent cardiovascular events: cardiac failure less than 10 days before, instable angina, coronary angioplasty less than 10 days cardiac surgery less than 1 month, valvulopathy requiring surgery, myopericarditis, severe Rhythm troubles despite medical treatment, stade IV arteriopathy.
- •BMI ≥ 30 kg/m² ;
- •Anxiety and mental disorder
- •Concomitant pathology leading to severe general status alteration.
- •Patient participating to another medical study
- •Electromyostimulation or effort entrainment program less than a month.
- •Patients on renal transplantation awaiting list.
- •Patient practicing sport ( response to Voorips test)
结局指标
主要结局
difference between distances during the 6 minutes walk test before and after the 3 month program between the stimulated and the non stimulated group
时间窗: 3 months
The primary outcome is the difference between distances during the 6 minutes walk test before and after the 3 month program between the stimulated and the non stimulated group
次要结局
- maximum strength developed during the ergometry, limited by symptoms; maximal charge during muscular test; quadricipital diameter; time for the " Timed up and go " test; quality of life scores.(3 months)