Improvement of Aerobic Capacity in Cystic Fibrosis Patients With a One-year Home Training Period
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Improvement of Aerobic Capacity in Cystic Fibrosis Patients With a One-year Home Training Period|
- Changing the criteria for assessing aerobic capacity: Variations in VO2 max. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: training group
supervised training program 3 times a week with coach.
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792194
|Contact: LONSDORFER Evelyne, MD||33388128331||Evelyne.Lonsdorfer@chru-strasbourg.fr|
|CHRU, Hôpital Civile, Service de Physiologie et Explorations Fonctionnelles||Recruiting|
|Contact: LONSDORFER Evelyne, MD 33388128331 Evelyne.Lonsdorfer@chru-strasbourg.fr|
|Sub-Investigator: KESSLER Romain, MD|
|Sub-Investigator: ROSNER Vincent, MD|
|Sub-Investigator: WEISS Laurence, MD|
|Sub-Investigator: OSWALD MAMMOSSER Monique, MD|
|Sub-Investigator: CHARLOUX Anne, MD|
|Sub-Investigator: DOUTRELEAU Stéphane, MD|
|Sub-Investigator: RICHARD Ruddy, MD|
|Principal Investigator:||LONSDORFER Evelyne, MD||not affiliated|