Assessment of Quadriceps Muscle Electrostimulation Used as an Additional Procedure for Effort Retraining in Patients Suffering From Cystic Fibrosis Associated With Severe Pulmonary Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- The six-minute walking distance
研究概览
简要总结
This is an add-on, randomized, open label, clinical trial that evaluates the use of quadriceps electrostimulation as an additional retraining procedure in patients suffering from cystic fibrosis.
详细描述
Cystic fibrosis is an autosomal recessive genetic disease due to a mutation of the CFTR protein gene. The CFTR protein transports chloride ions (Cl-) across cell membranes in the lungs, pancreas, digestive tract, reproductive tract, and skin.
CFTR mutation mainly leads to a dysfunction of the pulmonary system and pancreas exocrine function.
Several studies showed that cystic fibrosis commonly induces a reduction of effort tolerance, peripheral muscular strength and work capacity.
Patients suffering from cystic fibrosis with a high endurance capacity have a lower risk of poor prognosis. Those with a severe dyspnea have a higher benefit with a force training or a combined force and endurance training than with endurance training alone.
We propose to study the effect of a quadriceps electrostimulation program, performed prior to an endurance retraining program using a cycloergometer, in patients with cystic fibrosis associated with severe pulmonary dysfunction, to enhance their muscular performance and increase their adherence to the cycloergometer retraining program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age >= 18 years
- •Patient suffering from cystic fibrosis
- •Patient has at least three measures of maximum expiratory volume per second <= 45% of the theory among the 6 last measures performed
- •Affiliation to French social security
- •Capacity to consent
排除标准
- •Pregnant women
- •Contraindication to application of magnetic field
- •Pacemaker
- •History of neurosurgical intervention
- •Presence of metallic particles near the stimulation site.
结局指标
主要结局
The six-minute walking distance
时间窗: 0, 1, 2 months
次要结局
- Quality of life: CFQ14, BDI-TDI questionnaires(0, 1, 2 months)
- HOMA and QUICKI tests(0, 1, 2 months)
- Cycloergometer test: maximum power, maximum oxygen consumption, minute ventilation(1 month)
- Quadriceps muscle mass(0, 1, 2 months)
- Compliance with ergocycle rehabilitation(1 month)
- Inspiratory reserve volume (IRV), gasometry, dyspnea score(0, 1, 2 months)
- Measurement of voluntary maximum force and non cooperative force of the quadriceps(0, 1, 2 months)
- Area of quadriceps cross section measured with a scanner(1, 2 months)
- Spirometry(0, 1, 2 months)