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Effects of a 6-Months Physical Conditioning Program in Patients With Cystic Fibrosis

NCT ID: NCT00231686

Last Updated: 2005-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-11-30

Study Completion Date

2003-05-31

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis

Keywords

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Lung function test Physical conditioning, human Physical fitness Quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Supervised aerobic training

Intervention Type BEHAVIORAL

Supervised strength training

Intervention Type BEHAVIORAL

Unsupervised training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mukoviszidose eV (German CF society)

UNKNOWN

Sponsor Role collaborator

Schweizer CF-Gesellschaft (Swiss CF society)

UNKNOWN

Sponsor Role collaborator

Hannover Medical School

OTHER

Sponsor Role collaborator

Goethe University

OTHER

Sponsor Role collaborator

Triemli Hospital

OTHER

Sponsor Role collaborator

Julius-Maximilians University

OTHER

Sponsor Role lead

Principal Investigators

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Helge U Hebestreit, MD

Role: PRINCIPAL_INVESTIGATOR

Julius-Maximilians University, Würzburg, Germany

Susi Kriemler, MD

Role: PRINCIPAL_INVESTIGATOR

Stadtspital Triemli, Zürich Switzerland

Locations

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Johann Wolfgang Goethe Universität

Frankfurt, , Germany

Site Status

Medizinische Hochschule

Hanover, , Germany

Site Status

Children´s Hospital, Julius Maximilians University

Würzburg, , Germany

Site Status

Stadtspital Triemli

Zurich, , Switzerland

Site Status

Countries

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Germany Switzerland

References

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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.

Reference Type DERIVED
PMID: 24571729 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23588193 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19643946 (View on PubMed)

Other Identifiers

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MUKOTRAIN

Identifier Type: -

Identifier Source: org_study_id