IRAD2 : Patients With Respiratory Failure at Home

Last updated: July 7, 2009
Sponsor: University Hospital, Grenoble
Overall Status: Completed

Phase

3

Condition

Lung Injury

Respiratory Failure

Treatment

N/A

Clinical Study ID

NCT00230984
DCIC 01 05
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 dayand/or assisted ventilation > 6 hours per day.

  • PaO2 without oxygenotherapy ≤ 8 kPa or 60 mmHg on ambient air at the beginning ofassisted respiratory treatment.

  • Affection : chronic obstructive bronchopneumopathy, diffuse bronchial dilatation, nonneuromuscular restrictive syndrome (pulmonary diffuse infiltration, parietal lesion)obstructive and restrictive syndrome.

  • malnourished person, one of following criteria :Body Mass Index ≤ 21kg/m2 or weightloss (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

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), pathologicProstate Specific Antigen.

  • Inability to follow a rehabilitation program

Study Design

Total Participants: 200
Study Start date:
April 01, 2003
Estimated Completion Date:
June 30, 2008

Study 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.

Connect with a study center

  • University Hospital Dominique Larrey

    Limoges, 87042
    France

    Site Not Available

  • Rehabilitation Department of Cyr Voisin

    Loos, 59374
    France

    Site Not Available

  • University Hospital Arnaud de Villeneuve

    Montpellier, 34295
    France

    Site Not Available

  • Hospital la Pitiè-Salpétrière

    Paris, 75000
    France

    Site Not Available

  • University Hospital of Poitiers

    Poitiers, 86021
    France

    Site Not Available

  • University Hospital Bois Guillaume

    Rouen, 76230
    France

    Site Not Available

  • North University Hospital of St Etienne

    St Etienne, 42055
    France

    Site Not Available

  • Departement of Medicine, University Hospital of Genève

    Genève, 1211
    Switzerland

    Site Not Available

  • Departement of Medicine, University Hospital of Genève

    Genève, 1211
    Switzerland

    Site Not Available

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