Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chronic Respiratory Failure
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 200
- Locations
- 8
- Primary Endpoint
- An increase of the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life.
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief 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.
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
An increase of the six-minute walking distance by more than 50 m with an improvement in health-related quality-of-life.
Secondary Outcomes
- 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.