Cystic FibrosisNCT00792194
Improvement of Aerobic Capacity in Cystic Fibrosis Patients With a One-year Home Training Period
A study testing Exercise training in people with Cystic Fibrosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Life expectancy of patients with cystic fibrosis has improved dramatically the last few years. Respiratory complications remain the main contributory factor to the morbidity and mortality associated with the disease. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to Dec 2014
- Phase
- Interventional
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Man or woman with cystic fibrosis whose diagnosis was documented on clinical history and a test for detecting genetic or sweat test positive
- Patient who signed the informed consent (or parents for patients minors)
- Elderly aged 15 and over
- Patient affiliated with a social security
- Patient against non-cardiac indication of physical
- Patient in stable condition on a respirator with a higher FEV to 1000 ml
Show all 9Show fewer
- In the case of insulin-dependent diabetes, it must be balanced
- Patient had been informed of the results of the medical examination
- Women of childbearing age have achieved a pregnancy test on urine negative.
Who cannot join
- Diabetic patient unbalanced known cardiac pathology
- Patient on transplant list
- Patient major protected
- Patient under guardianship or trusteeship
- Safeguard patient justice
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU, Hôpital Civile, Service de Physiologie et Explorations Fonctionnelles
Strasbourg
About this study
Life expectancy of patients with cystic fibrosis has improved dramatically the last few years. Respiratory complications remain the main contributory factor to the morbidity and mortality associated with the disease. Exercise tolerance is reduced as the disease progresses, and peak aerobic capacity seems to be linked with survival. Regular physical activity has positive benefits, including a better body image, an improvement of pulmonary function, of exercise capacity and a possible improvement of quality of life.But because of the considerable variability of the subjects, exercise programs should be tailored to individual needs, and easy included in their cumbersome treatment routines and professional activities. In the cystic fibrosis center of Strasbourg we are able to propose to the patients a one-year physical exercise program, partly supervised with coaches, at home. Electronically braked cycle ergometer and heart rate monitoring system are at patients disposal, for one year, at home. Thus, patients can choose, during the day, the best moment to work out .Subjects will be randomised in two groups:1. a control group, where subjects are asked to continue their normal daily activities and physiotherapy regime.2. a training group, where subjects are asked to exercise three times a week. For the training group, three times a week, patients will train for 30 minutes. Heart rate will be continuously monitored and send to the medical staff every week-end . A correction of exercise intensity, if needed, is weekly proposed to maintain a maximal training efficiency, and coaches can help them, if necessary. For the two groups, quality of life will be measured with a disease-specific questionnaire (CFQ14+) (Henry, 1998, Quittner, 2000), and a generic questionnaire (SF 36) (Gee, 2002) before the program, and after 6 and 12 months. After a one year training program, and compared to the control group, we should expected an improvement in aerobic capacity and peak oxygen consumption, both associated with improved prognosis in cystic fibrosis. We also expected to observe an improvement in quality of life measurement, shorter hospital stays and fewer exacerbations. With this kind of program, we also would like to improve the degree of adherence in daily life exercise.
Read the detailed description
We hope that regular contact with the coaches or the medical staff will provide self-confidence. Thus, patients will probably be more able to choose a physical activity which will be enjoyable, shared with others (family, friends), and give real benefits in term of health status.
- Conditions
- Cystic Fibrosis
- Being tested
- Exercise training
- Keywords
- Cystic fibrosis, Exercise training, Home training, Aerobic capacity
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Also called no applicable
Subjects will be randomised in two groups:
a control group, where subjects are asked to continue their normal daily activities and physiotherapy regime.
a training group, where subjects are asked to exercise three times a week, whenever they want during the day.
| Study group | Role | What they receive |
|---|---|---|
| training group | Experimental | supervised training program 3 times a week with coach. Receives: Other: Exercise training |
| group without training | No intervention | a control group, where subjects are asked to continue their normal daily activities and physiotherapy regime. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing the criteria for assessing aerobic capacity: Variations in VO2 max.
Measured: 4 years
Secondary outcomes (1)
Assess the impact of retraining at home Going on the frequency of exacerbations, length of hospital stays, daily energy expenditure. Assess the impact of retraining at home
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LONSDORFER Evelyne, MD, Principal investigator, not affiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792194
- Sponsor's protocol ID
- 2007-A01452-51
- Status last verified
- Sep 2015
- First submitted
- 14 Nov 2008
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Aerobic Capacity in Cystic Fibrosis Patients With a One-year Home Training Period
- ClinicalTrials.gov ID
- NCT00792194
- Acronym / sponsor ID
- 2007-A01452-51
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Exercise training, Home training, Aerobic capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Nov 2008 (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.
Life expectancy of patients with cystic fibrosis has improved dramatically the last few years. Respiratory complications remain the main contributory factor to the morbidity and mortality associated with the disease. Exercise tolerance is reduced as the disease progresses, and peak aerobic capacity seems to be linked with survival. Regular physical activity has positive benefits, including a better body image, an improvement of pulmonary function, of exercise capacity and a possible improvement of quality of life.But because of the considerable variability of the subjects, exercise programs should be tailored to individual needs, and easy included in their cumbersome treatment routines and professional activities. In the cystic fibrosis center of Strasbourg we are able to propose to the patients a one-year physical exercise program, partly supervised with coaches, at home. Electronically braked cycle ergometer and heart rate monitoring system are at patients disposal, for one year, at home. Thus, patients can choose, during the day, the best moment to work out .Subjects will be randomised in two groups:1. a control group, where subjects are asked to continue their normal daily activities and physiotherapy regime.2. a training group, where subjects are asked to exercise three times a week. For the training group, three times a week, patients will train for 30 minutes. Heart rate will be continuously monitored and send to the medical staff every week-end . A correction of exercise intensity, if needed, is weekly proposed to maintain a maximal training efficiency, and coaches can help them, if necessary. For the two groups, quality of life will be measured with a disease-specific questionnaire (CFQ14+) (Henry, 1998, Quittner, 2000), and a generic questionnaire (SF 36) (Gee, 2002) before the program, and after 6 and 12 months. After a one year training program, and compared to the control group, we should expected an improvement in aerobic capacity and peak oxygen consumption, both associated with improved prognosis in cystic fibrosis. We also expected to observe an improvement in quality of life measurement, shorter hospital stays and fewer exacerbations. With this kind of program, we also would like to improve the degree of adherence in daily life exercise.
Detailed description
We hope that regular contact with the coaches or the medical staff will provide self-confidence. Thus, patients will probably be more able to choose a physical activity which will be enjoyable, shared with others (family, friends), and give real benefits in term of health status.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training group | Experimental | Other: Exercise trainingsupervised training program 3 times a week with coach. |
| group without training | No intervention | –a control group, where subjects are asked to continue their normal daily activities and physiotherapy regime. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Man or woman with cystic fibrosis whose diagnosis was documented on clinical history and a test for detecting genetic or sweat test positive
- Patient who signed the informed consent (or parents for patients minors)
- Elderly aged 15 and over
- Patient affiliated with a social security
- Patient against non-cardiac indication of physical
Key exclusion criteria (5 listed)
- Diabetic patient unbalanced known cardiac pathology
- Patient on transplant list
- Patient major protected
- Patient under guardianship or trusteeship
- Safeguard patient justice
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 |
|---|---|---|
| Exercise trainingAlso: no applicableSubjects will be randomised in two groups: a control group, where subjects are asked to continue their normal daily activities and physiotherapy regime. a training group, where subjects are asked to exercise three times a week, whenever they want during the day. | Other | training group |
Primary outcome
Changing the criteria for assessing aerobic capacity: Variations in VO2 max.
Time frame: 4 years
1 secondary outcome
Assess the impact of retraining at home Going on the frequency of exacerbations, length of hospital stays, daily energy expenditure. Assess the impact of retraining at home
Time frame: 4 years
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 30 Sep 2015.
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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.
LONSDORFER Evelyne, MD principal investigator
not affiliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Cystic Fibrosis, run by University Hospital, Strasbourg, France at 1 site in France.
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 9 inclusion and 5 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 30 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
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?
Changing the criteria for assessing aerobic capacity: Variations in VO2 max. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2015.