Evaluation of Functionnal ElectromyoStimulation on Leg In Advanced Chronic Heart Failure After Hospitalisation for Acute Decompensation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- VO2 peak
研究概览
简要总结
The purpose of the study is to test the efficacy of the Functionnal ElectromyoStimulation (FES) of lower limbs in advanced chronic heart failure. The hypothesis is that FES treatment could improve functional exercise capacity.
详细描述
Advanced Chronic Heart Failure (ACHF) is a severe and frequent disease inducing a strong limitation of exercise capacity and a poor quality of life. Hospitalisation for cardiac decompensation is frequent and could alter their incapacities because of muscular deconditionning. Tradionnal aerobic rehabilitation exercises fighting against this deconditionning are not relevant in these patients because of dyspnea.
In litterature, Functionnal Electrostimulation (FES) has been tested in stable Chronic Heart Failure (NYHA I to III), far from decompensation. Several authors showed the same improvements than those obtained with conventionnal rehabilitation on aerobic capacities (peak VO2, 6 minutes walking test) and quality of life.
The originality of this study is to test FES soon after acute heart decompensation in ACHF patients. This type of rehabilitation could represent in the future an alternative to conventionnal rehabilitation until the patients could be able to do aerobic exercise.
60 patients will be randomised between two groups, the firsth receiving FES (treatment group), the second receiving skin electrostimulation in the same place without muscular contraction (Sham group). Patient and evaluator do not know what type of stimulation they have. These treatments spread over six weeks, five days per seven. They are began in rehabilitation unit then continued at home.
The principal criteria of judgement of FES efficacy is peak VO2 after the protocol. Secondary criteria are distance to the six minutes walking test, muscular strengh of quadriceps, the muscle mass measured by Dual energy X-ray absorptiometry (DEXA), inflamatory dosage (TNF alpha, IL-1, IL-6, CRP), rest value of Muscle sympathetic nerve activity, score to Minnesota questionnaire and fuctionnal independance.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Advanced Chronic Heart Failure (NYHA III to IV)
- •Cardiac Ejection Fraction < 40 %
- •peak VO2 < 16 ml/kg/min,
- •optimal drug treatment of CHF,
- •hospitalised for acute decompensation but not in intensive care
排除标准
- •Chronic Obstructive Pulmonary Disease with FEV < 50%,
- •History of stroke with walking disability, dementia.
结局指标
主要结局
VO2 peak
时间窗: change between baseline and 60 days after the Functional Electromyo Stimulation
次要结局
- maximal quadriceps strengh(change between baseline and 60 days after the Functional Electromyo Stimulation)
- CRP(change between baseline and 60 days after the Functional Electromyo Stimulation)
- DEXA(change between baseline and 60 days after the Functional Electromyo Stimulation)
- interleukin 6(change between baseline and 60 days after the Functional Electromyo Stimulation)
- score of minessota test(change between baseline and 60 days after the Functional Electromyo Stimulation)
- score of Functional independency measure(change between baseline and 60 days after the Functional Electromyo Stimulation)
- Muscle nerve sympathetic activity (MSNA)(change between baseline and 60 days after the Functional Electromyo Stimulation)
- Six minutes walking test(change between baseline and 60 days after the Functional Electromyo Stimulation)
- interleukin 1(change between baseline and 60 days after the Functional Electromyo Stimulation)
- TNF alpha(change between baseline and 60 days after the Functional Electromyo Stimulation)
- BNP(change between baseline and 60 days after the Functional Electromyo Stimulation)