IRAD2 : Patients With Respiratory Failure at Home
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|ClinicalTrials.gov Identifier: NCT00230984|
Recruitment Status : Completed
First Posted : October 3, 2005
Last Update Posted : July 8, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion.|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|