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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00792194
First received: November 14, 2008
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Cystic Fibrosis
Other: Exercise training
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Changing the criteria for assessing aerobic capacity: Variations in VO2 max. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

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 [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792194

Contacts
Contact: LONSDORFER Evelyne, MD 33388128331 Evelyne.Lonsdorfer@chru-strasbourg.fr

Locations
France
CHRU, Hôpital Civile, Service de Physiologie et Explorations Fonctionnelles Recruiting
Strasbourg, France
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         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: LONSDORFER Evelyne, MD not affiliated
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00792194     History of Changes
Other Study ID Numbers: 2007-A01452-51
Study First Received: November 14, 2008
Last Updated: June 28, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
Cystic fibrosis
Exercise training
Home training
Aerobic capacity

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014