IRAD2 : Patients With Respiratory Failure at Home

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.

Conditions

• Chronic Respiratory Failure
• Nutritional Depletion

Interventions

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

Sponsors & Collaborators

• Societe Francophone de Nutrition Enterale et Parenterale

  collaborator OTHER

• Association ANTADIR ,

  collaborator UNKNOWN

• Ministry of Health, France

  collaborator OTHER_GOV

• Association AGIR à Dom,

  collaborator UNKNOWN

• Nutricia France, swizerland),

  collaborator UNKNOWN

• Organon

  collaborator INDUSTRY

• University Hospital, Grenoble

  lead OTHER

Principal Investigators

• Christophe PISON, MD · Pneumology Department, University Hospital of Grenoble

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-04-30

Primary Completion

2008-06-30

Completion

2008-06-30

Countries

• France
• Switzerland

Study Locations