Effects of a 6-Months Physical Conditioning Program in Patients With Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Supervised aerobic training
Supervised strength training
Unsupervised training
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Lung function test, Physical conditioning, human, Physical fitness, Quality of life
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of cystic fibrosis Able to engage in intense physical activities Exclusion Criteria: FEV1 <35%predicted Esophageal varicosis Pulmonary bullae Drop in arterial oxygen saturation with exercise <80% Non-CF related chronic diseases Signs of pulmonary hypertension (ECG and echocardiogram)
Sites / Locations
- Johann Wolfgang Goethe Universität
- Medizinische Hochschule
- Children´s Hospital, Julius Maximilians University
- Stadtspital Triemli
Outcomes
Primary Outcome Measures
Change in lung functions determined at 0,3,6,12,18,24 months
Change in exercise capacity determined at 0,3,6,12,18,24
months
Change in physical activity determined at 0,3,6,12,18,24 months
Change in quality of life determined at 0,3,6,12,18,24 months
Secondary Outcome Measures
Change in body fatness at 0,3,6,12,18,24 months
Full Information
NCT ID
NCT00231686
First Posted
September 30, 2005
Last Updated
September 30, 2005
Sponsor
Julius-Maximilians University
Collaborators
Mukoviszidose eV (German CF society), Schweizer CF-Gesellschaft (Swiss CF society), Hannover Medical School, Goethe University, Triemli Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00231686
Brief Title
Effects of a 6-Months Physical Conditioning Program in Patients With Cystic Fibrosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Julius-Maximilians University
Collaborators
Mukoviszidose eV (German CF society), Schweizer CF-Gesellschaft (Swiss CF society), Hannover Medical School, Goethe University, Triemli Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Lung function test, Physical conditioning, human, Physical fitness, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Supervised aerobic training
Intervention Type
Behavioral
Intervention Name(s)
Supervised strength training
Intervention Type
Behavioral
Intervention Name(s)
Unsupervised training
Primary Outcome Measure Information:
Title
Change in lung functions determined at 0,3,6,12,18,24 months
Title
Change in exercise capacity determined at 0,3,6,12,18,24
Title
months
Title
Change in physical activity determined at 0,3,6,12,18,24 months
Title
Change in quality of life determined at 0,3,6,12,18,24 months
Secondary Outcome Measure Information:
Title
Change in body fatness at 0,3,6,12,18,24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of cystic fibrosis
Able to engage in intense physical activities
Exclusion Criteria:
FEV1 <35%predicted
Esophageal varicosis
Pulmonary bullae
Drop in arterial oxygen saturation with exercise <80%
Non-CF related chronic diseases
Signs of pulmonary hypertension (ECG and echocardiogram)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helge U Hebestreit, MD
Organizational Affiliation
Julius-Maximilians University, Würzburg, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susi Kriemler, MD
Organizational Affiliation
Stadtspital Triemli, Zürich Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johann Wolfgang Goethe Universität
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medizinische Hochschule
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Children´s Hospital, Julius Maximilians University
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Stadtspital Triemli
City
Zurich
ZIP/Postal Code
8057
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
24571729
Citation
Hebestreit H, Schmid K, Kieser S, Junge S, Ballmann M, Roth K, Hebestreit A, Schenk T, Schindler C, Posselt HG, Kriemler S. Quality of life is associated with physical activity and fitness in cystic fibrosis. BMC Pulm Med. 2014 Feb 27;14:26. doi: 10.1186/1471-2466-14-26.
Results Reference
derived
PubMed Identifier
23588193
Citation
Kriemler S, Kieser S, Junge S, Ballmann M, Hebestreit A, Schindler C, Stussi C, Hebestreit H. Effect of supervised training on FEV1 in cystic fibrosis: a randomised controlled trial. J Cyst Fibros. 2013 Dec;12(6):714-20. doi: 10.1016/j.jcf.2013.03.003. Epub 2013 Apr 13.
Results Reference
derived
PubMed Identifier
19643946
Citation
Hebestreit H, Kieser S, Junge S, Ballmann M, Hebestreit A, Schindler C, Schenk T, Posselt HG, Kriemler S. Long-term effects of a partially supervised conditioning programme in cystic fibrosis. Eur Respir J. 2010 Mar;35(3):578-83. doi: 10.1183/09031936.00062409. Epub 2009 Jul 30.
Results Reference
derived
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Effects of a 6-Months Physical Conditioning Program in Patients With Cystic Fibrosis
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