IRAD2 : Patients With Respiratory Failure at Home

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Collaborators: Association AGIR à Dom,; Association ANTADIR ,; Ministry of Health, France; Nutricia France, swizerland),; Organon; Societe Francophone de Nutrition Enterale et Parenterale
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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