IRAD2 : Patients With Respiratory Failure at Home

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Completed

CT.gov ID

NCT00230984

Collaborator

Societe Francophone de Nutrition Enterale et Parenterale (Other), Association ANTADIR , (Other), Ministry of Health, France (Other), Association AGIR à Dom, (Other), Nutricia France, swizerland), (Other), Organon (Industry)

200

Enrollment

Locations

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Phase 3

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion.

Study Start Date :

Apr 1, 2003

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Outcome Measures

Primary Outcome Measures

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

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University Hospital Dominique Larrey	Limoges	France	87042
2	Rehabilitation Department of Cyr Voisin	Loos	France	59374
3	University Hospital Arnaud de Villeneuve	Montpellier	France	34295
4	Hospital la Pitiè-Salpétrière	Paris	France	75000
5	University Hospital of Poitiers	Poitiers	France	86021
6	University Hospital Bois Guillaume	Rouen	France	76230
7	North University Hospital of St Etienne	St Etienne	France	42055
8	Departement of Medicine, University Hospital of Genève	Genève	Switzerland	1211