IRAD2 : Patients With Respiratory Failure at Home

Overview

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.

Conditions

Interventions

Eligibility

Locations (8)

Outcomes