IRAD2 : Patients With Respiratory Failure at Home

This study has been completed.
Sponsor:
Collaborators:
Societe Francophone de Nutrition Enterale et Parenterale
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

September 30, 2005
July 7, 2009
April 2003
June 2008   (final data collection date for primary outcome measure)
An increase of the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life.
Same as current
Complete list of historical versions of study NCT00230984 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
IRAD2 : Patients With Respiratory Failure at Home
Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion.

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Switzerland
 
NCT00230984
DCIC 01 05
Not Provided
Not Provided
University Hospital, Grenoble
  • Societe Francophone de Nutrition Enterale et Parenterale
  • Association ANTADIR ,
  • Ministry of Health, France
  • Association AGIR à Dom,
  • Nutricia France, swizerland),
  • Organon
Principal Investigator: Christophe PISON, MD Pneumology Department, University Hospital of Grenoble
University Hospital, Grenoble
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP