Clinical trial NCT00230984: IRAD2 : Patients With Respiratory Failure at Home
Official title: Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Respiratory Failure
Nutritional Depletion
Keywords: Chronic Respiratory Failure
Pulmonary Rehabilitation
Nutritional Depletion
Home
COPD
Oral Dietary Supplements
Therapeutic Education
Androgens
Exacerbation
Survival
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Societe Francophone de Nutrition Enterale et Parenterale
name: Association ANTADIR ,
name: Ministry of Health, France
name: Association AGIR à Dom,
name: Nutricia France, swizerland),
name: Organon
First posted: 2005-10-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: An increase of the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life.
Secondary outcomes:
measure: Reduction in exacerbation rates by 25%
measure: Quality of life assessed by generic QOL.
measure: Reduction in health-related costs
measure: Increase in survival during the year following intervention.
Other outcomes:
Locations:
city: Limoges
country: France
facility: University Hospital Dominique Larrey
city: Loos
country: France
facility: Rehabilitation Department of Cyr Voisin
city: Montpellier
country: France
facility: University Hospital Arnaud de Villeneuve
city: Paris
country: France
facility: Hospital la Pitiè-Salpétrière
city: Poitiers
country: France
facility: University Hospital of Poitiers
city: Rouen
country: France
facility: University Hospital Bois Guillaume
city: St Etienne
country: France
facility: North University Hospital of St Etienne
city: Genève
country: Switzerland
facility: Departement of Medicine, University Hospital of Genève
Study officials:
affiliation: Pneumology Department, University Hospital of Grenoble
name: Christophe PISON, MD
role: PRINCIPAL_INVESTIGATOR
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