IRAD2 : Patients With Respiratory Failure at Home

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Completed

Phase 3

Conditions

Chronic Respiratory Failure

Nutritional Depletion

Treatments

Drug: 160 mg/d of oral testosterone undecanoate in men, 80 mg/d in women

Behavioral: education

Behavioral: exercises on an ergometric bicycle 3 to 5 times a week

Drug: Oral dietary supplements (563 kcal/d), RESPIFOR

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00230984

DCIC 01 05

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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