Improvement of Aerobic Capacity in Cystic Fibrosis Patients With a One-year Home Training Period

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Completed

CT.gov ID

NCT00792194

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Other: Exercise training	N/A

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

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

Improvement of Aerobic Capacity in Cystic Fibrosis Patients With a One-year Home Training Period

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: no applicable
No Intervention: group without training a control group, where subjects are asked to continue their normal daily activities and physiotherapy regime.

Arm

Intervention/Treatment

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 Names:

no applicable

No Intervention: group without training

a control group, where subjects are asked to continue their normal daily activities and physiotherapy regime.

Outcome Measures

Primary Outcome Measures

Changing the criteria for assessing aerobic capacity: Variations in VO2 max. [4 years]

Secondary Outcome Measures

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 [4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
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.