Cystic FibrosisPhase 2/3NCT00231686
Effects of a 6-Months Physical Conditioning Program in Patients With Cystic Fibrosis
A Phase 2/3 study testing Supervised aerobic training, Supervised strength training and Unsupervised training in people with Cystic Fibrosis, run by Julius-Maximilians University at 4 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Supervised aerobic training, Supervised strength training and Unsupervised training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2000to May 2003
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of cystic fibrosis
- Able to engage in intense physical activities
Who cannot join
- 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)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Johann Wolfgang Goethe Universität
Frankfurt, 60590
Medizinische Hochschule
Hanover, 30625
Children´s Hospital, Julius Maximilians University
Würzburg, 97080
About this study
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
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.
- Conditions
- Cystic Fibrosis
- Being tested
- Supervised aerobic training, Supervised strength training, Unsupervised training
- Keywords
- Lung function test, Physical conditioning, human, Physical fitness, Quality of life
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised aerobic trainingBehavioural
Supervised strength trainingBehavioural
Unsupervised trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
Change in body fatness at 0,3,6,12,18,24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startNov 2000
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Julius-Maximilians University
- Sponsor type
- University, hospital or other
- Collaborators
- Mukoviszidose eV (German CF society), Schweizer CF-Gesellschaft (Swiss CF society), Hannover Medical School, Goethe University, Triemli Hospital
- Investigators
- Helge U Hebestreit, MD, Principal investigator, Julius-Maximilians University, Würzburg, GermanySusi Kriemler, MD, Principal investigator, Stadtspital Triemli, Zürich Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231686
- Sponsor's protocol ID
- MUKOTRAIN
- Status last verified
- Sep 2005
- First submitted
- 30 Sep 2005
- Last updated
- 4 Oct 2005
- Results posted
- No
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 24571729Kriemler 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 23588193Hebestreit 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00231686
- Acronym / sponsor ID
- MUKOTRAIN
- Conditions
- Cystic Fibrosis
- Keywords
- Lung function test, Physical conditioning, human, Physical fitness, Quality of life
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Julius-Maximilians UniversityUniversity, hospital or other
- Collaborators
- Mukoviszidose eV (German CF society), Schweizer CF-Gesellschaft (Swiss CF society), Hannover Medical School, Goethe University, Triemli Hospital
- Study start
- Nov 2000
- Study completion
- May 2003
- First posted
- 4 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of cystic fibrosis
- Able to engage in intense physical activities
Key exclusion criteria (6 listed)
- FEV1 <35%predicted
- Esophageal varicosis
- Pulmonary bullae
- Drop in arterial oxygen saturation with exercise <80%
- Non-CF related chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised aerobic training | Behavioural | – |
| Supervised strength training | Behavioural | – |
| Unsupervised training | Behavioural | – |
Primary outcome
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
1 secondary outcome
Change in body fatness at 0,3,6,12,18,24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2005.
- Derived from this study: PubMed 24571729Hebestreit 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.
- Derived from this study: PubMed 23588193Kriemler 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.
- Derived from this study: PubMed 19643946Hebestreit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helge U Hebestreit, MD principal investigator
Julius-Maximilians University, Würzburg, Germany
Susi Kriemler, MD principal investigator
Stadtspital Triemli, Zürich Switzerland
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Supervised aerobic training, Supervised strength training and Unsupervised training in people with Cystic Fibrosis, run by Julius-Maximilians University at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lung functions determined at 0,3,6,12,18,24 months. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00231686, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2005.