Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231686
Status:
COMPLETED
Last Update Posted:
2005-10-04
First Post:
2005-09-30
Brief Title:
Effects of a 6-Months Physical Conditioning Program in Patients With Cystic Fibrosis
Sponsor:
Julius-Maximilians University
Organization:
Julius-Maximilians University
Study Overview
Official Title:
Effects of a 6-Months Physical Conditioning Program on Health Status and Physical Activity in Youths and Young Adults With Cystic Fibrosis - MUKOTRAIN
Status:
COMPLETED
Status Verified Date:
2005-09
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:
The purpose of this randomized controlled trial was to determine whether a and if so which physical conditioning program is effective to improve health status physical activity and quality of life in patients with cystic fibrosis A positive effect of physical conditioning was expected
Detailed Description:
A high level of physical activity might be beneficial for patients with cystic fibrosis CF Several studies have indicated that physical training might improve fitness and lung functions or at least slow the decline in lung functions However there are no long-term studies comparing the effects among aerobic training strength training and no training Furthermore motivation to continue a training with little variations between sessions has been shown to decline rapidly Thus adherence with such a program may be low Finally not all patients feel happy with the same program Therefore a home-based individualized sports program might be best suitable to achieve long term benefits The MUKOTRAIN study is a multicenter randomized controlled trial to determine the effects of a home-based physical training in patients with CF
Comparisons
Study A Patients training aerobically 3 30 min per week supervised in a sports club near their homes in addition to their baseline physical activity compared to patients training upper and lower body strength 3 30 min per week supervised in a sports club near their homes compared to patients maintaining their physical activity The supervised intervention lasted 6 months thereafter patients were followed for an additional 18 months
Study B Patients asked to participate in sport activities at least 3 60 min per week free choice of activities in addition to their baseline physical activity compared with patients asked to maintain their baseline physical activity
Comparisons
Study A Patients training aerobically 3 30 min per week supervised in a sports club near their homes in addition to their baseline physical activity compared to patients training upper and lower body strength 3 30 min per week supervised in a sports club near their homes compared to patients maintaining their physical activity The supervised intervention lasted 6 months thereafter patients were followed for an additional 18 months
Study B Patients asked to participate in sport activities at least 3 60 min per week free choice of activities in addition to their baseline physical activity compared with patients asked to maintain their baseline 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