IRAD2 : Patients With Respiratory Failure at Home

This study has been completed.
Sponsor:
Collaborators:
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
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00230984
First received: September 30, 2005
Last updated: July 7, 2009
Last verified: July 2006
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion.

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

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.

Estimated Enrollment: 200
Study Start Date: April 2003
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230984

Locations
France
University Hospital Dominique Larrey
Limoges, France, 87042
Rehabilitation Department of Cyr Voisin
Loos, France, 59374
University Hospital Arnaud de Villeneuve
Montpellier, France, 34295
Hospital la Pitiè-Salpétrière
Paris, France, 75000
University Hospital of Poitiers
Poitiers, France, 86021
University Hospital Bois Guillaume
Rouen, France, 76230
North University Hospital of St Etienne
St Etienne, France, 42055
Switzerland
Departement of Medicine, University Hospital of Genève
Genève, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Grenoble
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
Investigators
Principal Investigator: Christophe PISON, MD Pneumology Department, University Hospital of Grenoble
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00230984     History of Changes
Other Study ID Numbers: DCIC 01 05
Study First Received: September 30, 2005
Last Updated: July 7, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Chronic Respiratory Failure
Pulmonary Rehabilitation
Nutritional Depletion
Home
COPD
Oral Dietary Supplements
Therapeutic Education
Androgens
Exacerbation
Survival

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on April 21, 2014