IRAD2 : Patients With Respiratory Failure at Home
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.
|Chronic Respiratory Failure Nutritional Depletion||Behavioral: education Drug: Oral dietary supplements (563 kcal/d), RESPIFOR Behavioral: exercises on an ergometric bicycle 3 to 5 times a week Drug: 160 mg/d of oral testosterone undecanoate in men, 80 mg/d in women||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion.|
- An increase of the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life.
- 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.
|Study Start Date:||April 2003|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230984
|University Hospital Dominique Larrey|
|Limoges, France, 87042|
|Rehabilitation Department of Cyr Voisin|
|Loos, France, 59374|
|University Hospital Arnaud de Villeneuve|
|Montpellier, France, 34295|
|Hospital la Pitiè-Salpétrière|
|Paris, France, 75000|
|University Hospital of Poitiers|
|Poitiers, France, 86021|
|University Hospital Bois Guillaume|
|Rouen, France, 76230|
|North University Hospital of St Etienne|
|St Etienne, France, 42055|
|Departement of Medicine, University Hospital of Genève|
|Genève, Switzerland, 1211|
|Principal Investigator:||Christophe PISON, MD||Pneumology Department, University Hospital of Grenoble|