- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00820716
Exercise Training in Asthma
July 9, 2020 updated by: University Hospital, Strasbourg, France
Comparison of Two Types of Exercise Training for Asthmatic Subjects : Interests and Limits
The aim of the study is to compare two methods of exercise training: alternate load versus constant load realized at moderate or high intensities, in order to define the interests and the limits of each one of these two methods.
The finality is to make possible to the expert to choose what exercise training induces the best results quickly and to make its choice according to the therapeutic objectives which it lays down.We also evaluate the effects of these exercises training on the vagal response and the bronchial tone of the asthmatics.
From a clinical point of view, a close attention will be paid to the effects of these exercises training on the control of asthma and the quality of life of the subjects
Study Overview
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Strasbourg, France, 67 091
- Service de Physiologie et d'Explorations Fonctionnelles - Pôle de Pathologie Thoracique - Nouvel Hôpital Civil
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Strasbourg, France, 67091
- Service de Pneumologie - Pôle de Pathologie Thoracique - Nouvel Hôpital Civil
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 to 45 years old
- mild to moderate persistent asthma (GINA classification)
- stabilized asthma
- physical activity level between 5 and 11 (Baecke and coll, 1982)
- no contra-indication for physical training
Exclusion Criteria:
- cardiovascular pathology
- metabolic pathology
- traumatic pathology
- BMI≥30
- tobacco
- diabetes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CA
Exercise training with alternate load
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Comparison of two methods of exercise training: alternate load versus constant load realized at moderate or high intensities
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Active Comparator: CC
Exercise training with constant load
|
Comparison of two methods of exercise training: alternate load versus constant load realized at moderate or high intensities
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximal oxygen consumption (VO2max)
Time Frame: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
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At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
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Maximal power output (Pmax)
Time Frame: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
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At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Exhaled NO (eNO)
Time Frame: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
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At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
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Heart rate variability
Time Frame: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
|
At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
|
Force Expiratory Volume in one second (FEV1)
Time Frame: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
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At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Evelyne LONSDORFER, MD, Hôpitaux Universitaires de Strasbourg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 21, 2009
Primary Completion (Actual)
October 15, 2010
Study Completion (Actual)
October 15, 2010
Study Registration Dates
First Submitted
January 9, 2009
First Submitted That Met QC Criteria
January 9, 2009
First Posted (Estimate)
January 12, 2009
Study Record Updates
Last Update Posted (Actual)
July 14, 2020
Last Update Submitted That Met QC Criteria
July 9, 2020
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3825 (Other Identifier: VA Portland Health Care System)
- 2006-A00090-51
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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