IRAD2 : Patients With Respiratory Failure at Home

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Respiratory Failure, Nutritional Depletion

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: education|nan|
|Drug: Oral dietary supplements (563 kcal/d), RESPIFOR|nan|
|Behavioral: exercises on an ergometric bicycle 3 to 5 times a week|nan|
|Drug: 160 mg/d of oral testosterone undecanoate in men, 80 mg/d in women|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Respiratory Failure, Pulmonary Rehabilitation, Nutritional Depletion, Home, COPD, Oral Dietary Supplements, Therapeutic Education, Androgens, Exacerbation, Survival