Chronic Respiratory Failure, Nutritional Depletion
Conditions
Keywords
Chronic Respiratory Failure, Pulmonary Rehabilitation, Nutritional Depletion, Home, COPD, Oral Dietary Supplements, Therapeutic Education, Androgens, Exacerbation, Survival
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.
Interventions
BEHAVIORALeducation
DRUGOral dietary supplements (563 kcal/d), RESPIFOR
BEHAVIORALexercises on an ergometric bicycle 3 to 5 times a week
DRUG160 mg/d of oral testosterone undecanoate in men, 80 mg/d in women
Sponsors
Societe Francophone de Nutrition Enterale et Parenterale
Association ANTADIR ,
Ministry of Health, France
Association AGIR à Dom,
Nutricia France, swizerland),
Organon
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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. | — |
Countries
France, Switzerland
Outcome results
None listed