CClinicalTrials.gg
CompletedNCT00231686Updated Oct 4, 2005

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

A Phase 2/3 interventional study of Supervised aerobic training and Supervised strength training in Cystic Fibrosis, sponsored by Julius-Maximilians University. Completed at 4 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2005-10-04.

Sponsored by Julius-Maximilians University · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cystic Fibrosis

Keywords

  • Lung function test
  • Physical conditioning, human
  • Physical fitness
  • Quality of life
03

In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 80 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Julius-Maximilians University is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical diagnosis of cystic fibrosis
  • Able to engage in intense physical activities

Exclusion criteria

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)
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants

Interventions

  • BehavioralSupervised aerobic training
  • BehavioralSupervised strength training
  • BehavioralUnsupervised training
06

What researchers measure

Primary outcomes

  1. Change in lung functions determined at 0,3,6,12,18,24 months

  2. Change in exercise capacity determined at 0,3,6,12,18,24

  3. months

  4. Change in physical activity determined at 0,3,6,12,18,24 months

  5. Change in quality of life determined at 0,3,6,12,18,24 months

Secondary outcomes

  1. Change in body fatness at 0,3,6,12,18,24 months

07

Study locations

4 sites
  • Johann Wolfgang Goethe Universität
    Frankfurt, 60590, Germany
  • Medizinische Hochschule
    Hannover, 30625, Germany
  • Children´s Hospital, Julius Maximilians University
    Wuerzburg, 97080, Germany
  • Stadtspital Triemli
    Zurich, 8057, Switzerland
08

References and documents

Publications

  • 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. PubMed 24571729 ↗
  • 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. PubMed 23588193 ↗
  • 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. PubMed 19643946 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00231686
Lead sponsor
Julius-Maximilians University
Collaborators
Mukoviszidose eV (German CF society), Schweizer CF-Gesellschaft (Swiss CF society), Hannover Medical School, Goethe University, Triemli Hospital
First posted
Oct 4, 2005
Start date
Nov 2000
Completion
May 2003
Last update
Oct 4, 2005

Study contacts

Helge U Hebestreit, MD
principal investigator · Julius-Maximilians University, Würzburg, Germany
Susi Kriemler, MD
principal investigator · Stadtspital Triemli, Zürich Switzerland
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion