IRAD2 : Patients With Respiratory Failure at Home

Phase 3

Completed

• Conditions: Chronic Respiratory Failure; Nutritional Depletion

• Registration Number: NCT00230984
• Lead Sponsor: University Hospital, Grenoble

Brief 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.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-09-30
• Study First Posted: 2005-10-03
• Status Verified: 2006-07
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Last Update Submitted: 2009-07-07
• Last Update Posted: 2009-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
An increase of the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

Rehabilitation Department of Cyr Voisin; 🇫🇷 Loos, France

University Hospital Dominique Larrey; 🇫🇷 Limoges, France

Departement of Medicine, University Hospital of Genève; 🇨🇭 Genève, Switzerland

University Hospital of Poitiers; 🇫🇷 Poitiers, France

North University Hospital of St Etienne; 🇫🇷 St Etienne, France

University Hospital Arnaud de Villeneuve; 🇫🇷 Montpellier, France

Hospital la Pitiè-Salpétrière; 🇫🇷 Paris, France

University Hospital Bois Guillaume; 🇫🇷 Rouen, France