Improvement of Aerobic Capacity in Cystic Fibrosis Patients With a One-year Home Training Period
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ClinicalTrials.gov Identifier: NCT00792194 |
Recruitment Status
:
Completed
First Posted
: November 17, 2008
Last Update Posted
: September 30, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cystic Fibrosis | Other: Exercise training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
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 : | December 2008 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2014 |

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 Name: no applicable
|
No Intervention: group without training
a control group, where subjects are asked to continue their normal daily activities and physiotherapy regime.
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- Changing the criteria for assessing aerobic capacity: Variations in VO2 max. [ Time Frame: 4 years ]
- 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 ]

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Ages Eligible for Study: | 15 Years to 65 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00792194
France | |
CHRU, Hôpital Civile, Service de Physiologie et Explorations Fonctionnelles | |
Strasbourg, France |
Principal Investigator: | LONSDORFER Evelyne, MD | not affiliated |
Responsible Party: | University Hospital, Strasbourg, France |
ClinicalTrials.gov Identifier: | NCT00792194 History of Changes |
Other Study ID Numbers: |
2007-A01452-51 |
First Posted: | November 17, 2008 Key Record Dates |
Last Update Posted: | September 30, 2015 |
Last Verified: | September 2015 |
Keywords provided by University Hospital, Strasbourg, France:
Cystic fibrosis Exercise training Home training Aerobic capacity |
Additional relevant MeSH terms:
Fibrosis Cystic Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |