IRAD2 : Patients With Respiratory Failure at Home

• 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.

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.

• 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

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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

• The Francophone Society of Enteral and Parenteral Nutrition (Société Francophone de Nutrition Entérale et Parentérale),
• Association ANTADIR ,
• Ministry of Health, France
• Association AGIR à Dom,
• Nutricia France, swizerland),
• Organon