Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230984
Status:
COMPLETED
Last Update Posted:
2009-07-08
First Post:
2005-09-30
Brief Title:
IRAD2 Patients With Respiratory Failure at Home
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 mgd of oral testosterone undecanoate in men 80 mgd in women oral dietary supplements 563 kcald 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
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 mgd of oral testosterone undecanoate in men 80 mgd in women oral dietary supplements 563 kcald 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None