Physical ActivityAsthmeactNCT03232606
Physical Activity of Asthmatic Children
An observational study of Physical Activity and Asthma, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Physical activity is mandatory to the optimal development and health of children. The presence of asthmatic manifestations may influence the comportment of children and its family toward exercise and practice of sports. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Physical Activity, Asthma, Child Development
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2017to 10 Nov 2017
- Phase
- Observational
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Asthmatic cohort of the asthma clinic of the children hospital
Who may be able to join
- Asthmatic children coming for regular follow-up
- Good control of asthma
Who cannot join
- Previous pathologies with significant impact on physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity of Asthmatic School Children and Teenagers: Evaluation and Perspectives
Physical activity is mandatory to the optimal development and health of children. The presence of asthmatic manifestations may influence the comportment of children and its family toward exercise and practice of sports. There no scientific argument to advice a reduction of physical activity in asthmatic children, but previous studies showed that physical activity is reduced in asthmatic children.
The aim of this observational study is to evaluate the existing factors leading to this reduction of physical activity in asthmatic children and their families.
Read the detailed description
Physical activity is mandatory to the optimal development and health of children. The presence of asthmatic manifestations may influence the behaviour of children and its family with a significant reduction of exercise and practice of sports.
There no scientific argument to advice such a reduction of physical activity in asthmatic children.
The aim of this observational study is to evaluate the existing factors leading to this reduction of physical activity in asthmatic children and their families.
To evaluate the factors explaining this behaviour the investigator design an observational study, based on a questionnaire.
The evaluation of the number of sujets to complete this study is 50 asthmatic children. The whole population will be considered as the same group. This study may be further completed by a comparative and new study including asthmatic and non-asthmatic children.
- Conditions
- Physical Activity, Asthma, Child Development
- Medical subject headings
- Motor Activity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthmatic children | Asthmatic children aged 6 to 17 year old coming to follow-up at asthma clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity of children
Score
Measured: inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start25 Sep 2017
- Primary completion10 Nov 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lorraine
- Responsible party
- Sponsor
- Investigators
- Cyril E SCHWEITZER, MD,PhD, Principal investigator, University of Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232606
- Sponsor's protocol ID
- N°ID-RCB: 2017-A01483-50
- Acronym
- Asthmeact
- Status last verified
- Aug 2019
- First submitted
- 27 Jun 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity of Asthmatic School Children and Teenagers: Evaluation and Perspectives
- ClinicalTrials.gov ID
- NCT03232606
- Acronym / sponsor ID
- Asthmeact / N°ID-RCB: 2017-A01483-50
- Conditions
- Physical Activity, Asthma, Child Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- University of Lorraine
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 28 Jul 2017 (actual)
- 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.
Physical activity is mandatory to the optimal development and health of children. The presence of asthmatic manifestations may influence the comportment of children and its family toward exercise and practice of sports. There no scientific argument to advice a reduction of physical activity in asthmatic children, but previous studies showed that physical activity is reduced in asthmatic children.
The aim of this observational study is to evaluate the existing factors leading to this reduction of physical activity in asthmatic children and their families.
Detailed description
Physical activity is mandatory to the optimal development and health of children. The presence of asthmatic manifestations may influence the behaviour of children and its family with a significant reduction of exercise and practice of sports.
There no scientific argument to advice such a reduction of physical activity in asthmatic children.
The aim of this observational study is to evaluate the existing factors leading to this reduction of physical activity in asthmatic children and their families.
To evaluate the factors explaining this behaviour the investigator design an observational study, based on a questionnaire.
The evaluation of the number of sujets to complete this study is 50 asthmatic children. The whole population will be considered as the same group. This study may be further completed by a comparative and new study including asthmatic and non-asthmatic children.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthmatic children | – | –Asthmatic children aged 6 to 17 year old coming to follow-up at asthma clinic |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Asthmatic cohort of the asthma clinic of the children hospital
Key inclusion criteria (2 listed)
- Asthmatic children coming for regular follow-up
- Good control of asthma
Key exclusion criteria (1 listed)
- Previous pathologies with significant impact on physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical activity of children
Time frame: inclusion visit
Score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Cyril E SCHWEITZER, MD,PhD principal investigator
University of Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity and Asthma, run by Central Hospital, Nancy, France at 1 site 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical activity of children (time frame: inclusion visit). 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 13 Aug 2019.