Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00792194
Recruitment Status : Completed
First Posted : November 17, 2008
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date  ICMJE November 14, 2008
First Posted Date  ICMJE November 17, 2008
Last Update Posted Date September 30, 2015
Study Start Date  ICMJE December 2008
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2008)
Changing the criteria for assessing aerobic capacity: Variations in VO2 max. [ Time Frame: 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Arms  ICMJE
  • Experimental: training group
    supervised training program 3 times a week with coach.
    Intervention: Other: Exercise training
  • No Intervention: group without training
    a control group, where subjects are asked to continue their normal daily activities and physiotherapy regime.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2008)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Exclusion Criteria:

  • Diabetic patient unbalanced known cardiac pathology
  • Patient on transplant list
  • Patient major protected
  • Patient under guardianship or trusteeship
  • Safeguard patient justice
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00792194
Other Study ID Numbers  ICMJE 2007-A01452-51
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Strasbourg, France
Study Sponsor  ICMJE University Hospital, Strasbourg, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: LONSDORFER Evelyne, MD not affiliated
PRS Account University Hospital, Strasbourg, France
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP