irad2 : patients with respiratory failure at home

Conditions: Chronic Respiratory Failure; Nutritional Depletion

Summary: 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.

Eligibility criteria:
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

Keywords: chronic respiratory failure pulmonary rehabilitation nutritional depletion home copd oral dietary supplements therapeutic education androgens exacerbation survival