Improvement of Aerobic Capacity in Cystic Fibrosis Patients With a One-year Home Training Period
| Tracking Information | |||||
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| First Received Date ICMJE | November 14, 2008 | ||||
| Last Updated Date | June 28, 2012 | ||||
| Start Date ICMJE | December 2008 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Changing the criteria for assessing aerobic capacity: Variations in VO2 max. [ Time Frame: 4 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00792194 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Improvement of Aerobic Capacity in Cystic Fibrosis Patients With a One-year Home Training Period | ||||
| Official Title ICMJE | Improvement of Aerobic Capacity in Cystic Fibrosis Patients With a One-year Home Training Period | ||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE | Cystic Fibrosis | ||||
| Intervention ICMJE | Other: Exercise training
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. Other Name: no applicable |
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| Study Arm (s) | Experimental: training group
supervised training program 3 times a week with coach.
Intervention: Other: Exercise training |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 15 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00792194 | ||||
| Other Study ID Numbers ICMJE | 2007-A01452-51 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University Hospital, Strasbourg, France | ||||
| Study Sponsor ICMJE | University Hospital, Strasbourg, France | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Strasbourg, France | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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