Interest of Branched Chain Amino Acids Associated With a Respiratory Rehabilitation Program in Patients Broncho Chronic Obstructive Pulmonary Disease. Randomized Study Against Placebo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- maximum oxygene uptake
研究概览
简要总结
Respiratory rehabilitation is one of the main treatments for COPD in the early stages of the disease (Stage 2 of GOLD) with a recognized effect on improving the capacity of the patients to exert effort by fighting against deconditioning. the effort. This treatment also improves the quality of life of patients and reduces the risk of respiratory exacerbations. The patients are very often malnourished and various studies have proposed the addition of oral supplementation such as hormone therapy (testosterone) to improve the exercise performance of these atrophied muscles. The use of branched-chain amino acids (AARs) such as valine, leucine, isoleucine in this indication can be fully justified because they stimulate protein synthesis and promote muscle maintenance and repair.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients Broncho Chronic Obstructive Pulmonary Disease in stages 2 and 3 of the GOLD classification, whose Maximum Expiratory Volume on the first second is between 30% and 80% of the expected theoretical value, associated with a maximal expiratory volume ratio on the first Second / Vital Capacity less than or equal to 70% of the expected theoretical value.
- •Patients of both sexes, aged 40 to 80 years
- •In case of active smoking, patients must commit to interrupting it during the respiratory rehabilitation program that will be proposed to them in this study
排除标准
- •- Age <40 years or> 80 years
- •Patients with a contraindication to exercise,
- •Phenylketonuria
- •Patients treated with long-term oxygen therapy and / or home ventilation will not be included.
- •Patients with acute respiratory decompensation in the three months prior to inclusion.
- •Patients with known allergy to milk, gluten, soy, egg and nuts
- •Patients taking part in another clinical trial or who have participated in a clinical trial in the 3 months preceding this study.
研究组 & 干预措施
Retraining with respiratory effort+ amino acids
干预措施: Amino Acids (Drug)
Retraining with respiratory effort+ placebo
干预措施: Placebos (Drug)
结局指标
主要结局
maximum oxygene uptake
时间窗: after 6 weeks of treatment
maximum oxygene uptake measured during intensive exercise
次要结局
未报告次要终点