AsthmaNCT00820716
Exercise Training in Asthma
A study testing Exercise training in people with Asthma, run by University Hospital, Strasbourg, France at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Asthma
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Sep 2009to 15 Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- cardiovascular pathology
- metabolic pathology
- traumatic pathology
- BMI≥30
- tobacco
- diabetes
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de Physiologie et d'Explorations Fonctionnelles - Pôle de Pathologie Thoracique - Nouvel Hôpital Civil
Strasbourg, 67 091
Service de Pneumologie - Pôle de Pathologie Thoracique - Nouvel Hôpital Civil
Strasbourg, 67091
About this study
Official title: 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
- Conditions
- Asthma
- Being tested
- Exercise training
- Keywords
- Asthma, Asthmatic subjects, Exercise training, Constant load, Alternate load
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Comparison of two methods of exercise training: alternate load versus constant load realized at moderate or high intensities
| Study group | Role | What they receive |
|---|---|---|
| CA | Experimental | Exercise training with alternate load Receives: Other: Exercise training |
| CC | Active comparator | Exercise training with constant load Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen consumption (VO2max)
Measured: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
Maximal power output (Pmax)
Measured: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
Secondary outcomes (3)
Exhaled NO (eNO)
Measured: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
Heart rate variability
Measured: 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)
Measured: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study start21 Sep 2009
- Primary completion15 Oct 2010
- Study completion15 Oct 2010
Why it stopped: Difficulties in recruiting patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evelyne LONSDORFER, MD, Study director, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820716
- Sponsor's protocol ID
- 3825
- Other IDs
- 2006-A00090-51
- Status last verified
- Aug 2011
- First submitted
- 9 Jan 2009
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Types of Exercise Training for Asthmatic Subjects : Interests and Limits
- ClinicalTrials.gov ID
- NCT00820716
- Acronym / sponsor ID
- 3825
- Conditions
- Asthma
- Keywords
- Asthma, Asthmatic subjects, Exercise training, Constant load, Alternate load
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruiting patient
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 21 Sep 2009 (actual)
- Primary completion
- 15 Oct 2010 (actual)
- Study completion
- 15 Oct 2010 (actual)
- First posted
- 12 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CA | Experimental | Other: Exercise trainingExercise training with alternate load |
| CC | Active comparator | Other: Exercise trainingExercise training with constant load |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- cardiovascular pathology
- metabolic pathology
- traumatic pathology
- BMI≥30
- tobacco
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingComparison of two methods of exercise training: alternate load versus constant load realized at moderate or high intensities | Other | CA, CC |
Primary outcome
Maximal oxygen consumption (VO2max)
Time frame: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
Maximal power output (Pmax)
Time frame: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
3 secondary outcomes
Exhaled NO (eNO)
Time frame: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training
Heart rate variability
Time frame: 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
Results and safety
The study was stopped early (reason given: Difficulties in recruiting patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evelyne LONSDORFER, MD study director
Hôpitaux Universitaires de Strasbourg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Asthma, run by University Hospital, Strasbourg, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruiting patient). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal oxygen consumption (VO2max) (time frame: At T-1 = eight weeks before training - At T0 = beginning of training - At T1 = eight weeks after training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.