NCT00230984

IRAD2 : Patients With Respiratory Failure at Home

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Chronic Respiratory Failure
• Nutritional Depletion

Interventions

Type	Name	Description
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

Timeline

• Start date: 2003-04-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2005-10-03
• Last updated: 2009-07-08

Locations

8 sites across 2 countries: France, Switzerland