Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 16
- 主要终点
- An increase of the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life.
研究概览
简要总结
Title : Effects of home pulmonary rehabilitation in patients with chronic respiratory failure and nutritional depletion.
This is a randomized controlled, open clinical trial with two groups.
- first group, 100 patients : control group, patients followed with no add-on intervention
- Second group, 100 patients : rehabilitation group with education, oral supplements, exercise and androgenic steroids.
详细描述
Title : Effects of home pulmonary rehabilitation in patients with chronic respiratory failure and nutritional depletion
State of the art :
The IRAD2 trial is evaluating a 3-month home intervention which includes education, oral supplements, exercise and androgenic steroids in undernourished patients with chronic respiratory failure. The main objective is to increase the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life. Secondary end-points include a reduction in exacerbation rates by 25%, a reduction in health-related costs and an increase in survival during the year following intervention.
Material and methods :
This interventional, multi-centre, prospective, two-armed parallel, controlled trial is being conducted in 200 patients. In both groups, "Control" and "Rehabilitation", 7 home visits are scheduled during the 3-month intervention for education purpose. In the "Rehabilitation" group, patients will receive 160 mg/d of oral testosterone undecanoate in men, 80 mg/d in women, oral dietary supplements (563 kcal/d) and exercises on an ergometric bicycle 3 to 5 times a week.
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
- •well informed and consenting person
- •woman is old enough to procreate
- •Assisted respiratory treatment at home for 3 months : oxygenotherapy > 8 hours per day and/or assisted ventilation > 6 hours per day.
- •PaO2 without oxygenotherapy ≤ 8 kPa or 60 mmHg on ambient air at the beginning of assisted respiratory treatment.
- •Affection : chronic obstructive bronchopneumopathy, diffuse bronchial dilatation, non neuromuscular restrictive syndrome (pulmonary diffuse infiltration, parietal lesion) obstructive and restrictive syndrome.
- •malnourished person, one of following criteria :Body Mass Index ≤ 21kg/m2 or weight loss (10% of the previous weight) or non-fatty mass measured by 50 Hz impedancemetry ≤25th percentiles or ≤ 63% of ideal weight for women, ≤ 67% of ideal weight for men.
排除标准
- •Sleep apnea with daytime drowsiness (drowsiness scale of Epworth > 9/24)
- •Known pathology that reduce the vital prognosis at 6 months (AIDS, cancer...).
- •History of hormone dependent cancer ( breast cancer, prostate cancer), pathologic Prostate Specific Antigen.
- •Inability to follow a rehabilitation program
结局指标
主要结局
An increase of the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life.
次要结局
- Reduction in exacerbation rates by 25%
- Quality of life assessed by generic QOL.
- Reduction in health-related costs
- Increase in survival during the year following intervention.