IRAD2 : Patients With Respiratory Failure at Home

Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion.

Societe Francophone de Nutrition Enterale et Parenterale, Association ANTADIR ,, Ministry of Health, France, Association AGIR à Dom,, Nutricia France, swizerland),, Organon

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.

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. Expected results : In the event of significant responses to intervention, this trial would validate a comprehensive and global home-care for undernourished patients with chronic respiratory failure combining therapeutic education, oral supplements, androgenic substitution and physical activity.

Chronic Respiratory Failure, Pulmonary Rehabilitation, Nutritional Depletion, Home, COPD, Oral Dietary Supplements, Therapeutic Education, Androgens, Exacerbation, Survival

An increase of the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life.

Inclusion Criteria: 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. Exclusion Criteria: 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

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