Back to resultsExercise Training in Asthma
Primary Purpose
Asthma
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional supportive care trial for Asthma focused on measuring Asthma, Asthmatic subjects, Exercise training, Constant load, Alternate load
Eligibility Criteria
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
Sites / Locations
- Service de Physiologie et d'Explorations Fonctionnelles - Pôle de Pathologie Thoracique - Nouvel Hôpital Civil
- Service de Pneumologie - Pôle de Pathologie Thoracique - Nouvel Hôpital Civil
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CA
CC
Arm Description
Exercise training with alternate load
Exercise training with constant load
Outcomes
Primary Outcome Measures
Maximal oxygen consumption (VO2max)
Maximal power output (Pmax)
Secondary Outcome Measures
Exhaled NO (eNO)
Heart rate variability
Force Expiratory Volume in one second (FEV1)
Full Information
NCT ID
NCT00820716
First Posted
January 9, 2009
Last Updated
July 9, 2020
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT00820716
Brief Title
Exercise Training in Asthma
Official Title
Comparison of Two Types of Exercise Training for Asthmatic Subjects : Interests and Limits
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in recruiting patient
Study Start Date
September 21, 2009 (Actual)
Primary Completion Date
October 15, 2010 (Actual)
Study Completion Date
October 15, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Asthmatic subjects, Exercise training, Constant load, Alternate load
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CA
Arm Type
Experimental
Arm Description
Exercise training with alternate load
Arm Title
CC
Arm Type
Active Comparator
Arm Description
Exercise training with constant load
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
Comparison of two methods of exercise training: alternate load versus constant load realized at moderate or high intensities
Primary Outcome Measure Information:
Title
Maximal oxygen consumption (VO2max)
Time Frame
At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
Title
Maximal power output (Pmax)
Time Frame
At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
Secondary Outcome Measure Information:
Title
Exhaled NO (eNO)
Time Frame
At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
Title
Heart rate variability
Time Frame
At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelyne LONSDORFER, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Study Director
Facility Information:
Facility Name
Service de Physiologie et d'Explorations Fonctionnelles - Pôle de Pathologie Thoracique - Nouvel Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67 091
Country
France
Facility Name
Service de Pneumologie - Pôle de Pathologie Thoracique - Nouvel Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
12. IPD Sharing Statement
Learn more about this trial
Exercise Training in Asthma
We'll reach out to this number within 24 hrs