Clinical trial NCT00231686: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cystic Fibrosis
Keywords: Lung function test
Physical conditioning, human
Physical fitness
Quality of life
Lead sponsor: Julius-Maximilians University
Sponsor class: OTHER
Collaborators: name: Mukoviszidose eV (German CF society)
name: Schweizer CF-Gesellschaft (Swiss CF society)
name: Hannover Medical School
name: Goethe University
name: Triemli Hospital
First posted: 2005-10-04
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in lung functions determined at 0,3,6,12,18,24 months
measure: Change in exercise capacity determined at 0,3,6,12,18,24
measure: months
measure: Change in physical activity determined at 0,3,6,12,18,24 months
measure: Change in quality of life determined at 0,3,6,12,18,24 months
Secondary outcomes:
measure: Change in body fatness at 0,3,6,12,18,24 months
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe Universität
city: Hannover
country: Germany
facility: Medizinische Hochschule
city: Wuerzburg
country: Germany
facility: Children´s Hospital, Julius Maximilians University
city: Zurich
country: Switzerland
facility: Stadtspital Triemli
Study officials:
affiliation: Julius-Maximilians University, Würzburg, Germany
name: Helge U Hebestreit, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stadtspital Triemli, Zürich Switzerland
name: Susi Kriemler, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.