AsthmaNCT05900128
Impact of Exercise on Ashtma in Adults
A study testing workshop and no workshop in people with Asthma and Physical Inactivity, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
The aim of this study is to evaluate if physical activity could improve asthma control and management in adults. With this purpose we enroll asthmatic patients between 18-64 years old, and randomized them into 2 groups: in the first, patients will receive some workshops about asthma en physical exercise; in the second… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Asthma, Physical Inactivity
- What is being tested?
- workshop and no workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2023to 28 Feb 2024
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- asthma well controlled
- sedentarism (<150 min physical activity/day and/or <7000 daily steps)
Who cannot join
- pregnancy
- cardiological, not well controlled deseases
- other cronic pulmonary deseases
- bad asthma control
- not sign IC
- unable to practice physical activity (for cognitive or physical conditions)
- no devices able to count steps and physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Exercise on Asthma Control and Management in Adults
The aim of this study is to evaluate if physical activity could improve asthma control and management in adults. With this purpose we enroll asthmatic patients between 18-64 years old, and randomized them into 2 groups: in the first, patients will receive some workshops about asthma en physical exercise; in the second no educational intervention will be done. All patients will use a step counter in order to evaluate their activity during the study. Spirometric values and questionnaries about asthma control and quality of life will be recorded for all patients. Finally 2 groups will be comparated in order to search any difference in quality of life and asthma control.
Read the detailed description
52 asthmatic will be enrolled and randomized into 2 groups. All patients will send a weekly summary of their physical activity (mean number of steps and time of physical activity). All patients will be undergone to a medical visit at month 1 and 3 since study start. In each visit a spirometry, a FeNo, ACQ and AQLQ questionnaires will be done.
The patients of the intervention group will receive 3 workshops about asthma and physical exercise in order to provide information, medical support, and to resolve any question or difficulty about it. The workshops will be al week 1, 2 and 4 since study start.
- Conditions
- Asthma, Physical Inactivity
- Being tested
- workshop, no workshop
- Keywords
- asthma, sedentarism, spirometry, physical excercise
- Medical subject headings
- Asthma, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
workshopBehavioural
Patients will receive workshops and they will encourage to practice physical activity
no workshopOther
patients won't receive educative workshops
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | asthmatic patients who receive the educative intervention Receives: Behavioral: workshop |
| no intervention | Placebo comparator | asthmatic patients who don't receive the educative intervention Receives: Other: no workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of asthma control
change of 0.5 points in Asthma Control Questionnaire (0-6; higher score means worse result)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jun 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sarah micozzi, MD, Principal investigator, Hospital Rey Juan Carlos-Instituto de Investigación FJD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900128
- Sponsor's protocol ID
- EC075-23_HRJC
- Status last verified
- Apr 2024
- First submitted
- 2 Jun 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pending to decide if share the final report with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise on Asthma Control and Management in Adults
- ClinicalTrials.gov ID
- NCT05900128
- Acronym / sponsor ID
- EC075-23_HRJC
- Conditions
- Asthma, Physical Inactivity
- Keywords
- asthma, sedentarism, spirometry, physical excercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 12 Jun 2023 (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.
The aim of this study is to evaluate if physical activity could improve asthma control and management in adults. With this purpose we enroll asthmatic patients between 18-64 years old, and randomized them into 2 groups: in the first, patients will receive some workshops about asthma en physical exercise; in the second no educational intervention will be done. All patients will use a step counter in order to evaluate their activity during the study. Spirometric values and questionnaries about asthma control and quality of life will be recorded for all patients. Finally 2 groups will be comparated in order to search any difference in quality of life and asthma control.
Detailed description
52 asthmatic will be enrolled and randomized into 2 groups. All patients will send a weekly summary of their physical activity (mean number of steps and time of physical activity). All patients will be undergone to a medical visit at month 1 and 3 since study start. In each visit a spirometry, a FeNo, ACQ and AQLQ questionnaires will be done.
The patients of the intervention group will receive 3 workshops about asthma and physical exercise in order to provide information, medical support, and to resolve any question or difficulty about it. The workshops will be al week 1, 2 and 4 since study start.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: workshopasthmatic patients who receive the educative intervention |
| no intervention | Placebo comparator | Other: no workshopasthmatic patients who don't receive the educative intervention |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- asthma well controlled
- sedentarism (<150 min physical activity/day and/or <7000 daily steps)
Key exclusion criteria (7 listed)
- pregnancy
- cardiological, not well controlled deseases
- other cronic pulmonary deseases
- bad asthma control
- not sign IC
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 |
|---|---|---|
| workshopPatients will receive workshops and they will encourage to practice physical activity | Behavioural | Intervention |
| no workshoppatients won't receive educative workshops | Other | no intervention |
Primary outcome
Improvement of asthma control
Time frame: 3 months
change of 0.5 points in Asthma Control Questionnaire (0-6; higher score means worse result)
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 12 Jul 2024.
- Individual participant dataSharing planned: No. Pending to decide if share the final report with other researchers
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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.
sarah micozzi, MD principal investigator
Hospital Rey Juan Carlos-Instituto de Investigación FJD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing workshop and no workshop in people with Asthma and Physical Inactivity, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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 7 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 12 Jul 2024. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Improvement of asthma control (time frame: 3 months). 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 12 Jul 2024.