AsthmaNCT06449573
Evaluation of Cardiopulmonary Parameters in Individuals With Asthma
An observational study of Asthma, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study compare the cardiopulmonary parameters of individuals with asthma with healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Exercise capacity
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to Mar 2025
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include asthma patients followed up by Hacettepe University Faculty of Medicine, Department of Chest Diseases, Immunology and Allergy Branch and healthy individuals.
Who may be able to join
- No respiratory, cardiovascular and metabolic diseases
- Regular non-smoker
Who cannot join
- Non-consenting
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara
Aydan Aslı Aksel Uylar, +90312 ext. 3051576, aydanaaksel@gmail.com
About this study
The aim of the study compare the cardiopulmonary parameters of individuals with asthma with healthy subjects.
Read the detailed description
It is thought that aerobic capacity of asthmatic individuals decreases due to chronic respiratory disease, especially oxygen consumption. Detailed investigation will be provided with this research.
- Conditions
- Asthma
- Being tested
- Exercise capacity
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise capacityOther
cardiopulmonary exercise test used assessment of exercise capacity
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Inclusion Criteria:
* Patients receiving step 5 asthma treatment
* 18-65 years
* Asthma under control (asthma control test ≥20)
* No more than 2 exacerbations in the last 1 year
Exclusion Criteria:
* Non-consenting
* Patients with asthma exacerbation requiring systemic steroid use for at least 3 days in the last 1 month
* Being an active smoker Receives: Other: Exercise capacity | |
| Healthy Individuals | Inclusion Criteria:
* No respiratory, cardiovascular and metabolic diseases
* Regular non-smoker
Exclusion Criteria:
* Non-consenting
* Pregnant women Receives: Other: Exercise capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
Exercise capacity will be assessed by Cardiopulmonary Exercise Test. The test will be performed on a bicycle ergometer. The test will be terminated when the target heart rate is reached or when the patient indicates that they are unable to continue the test. maximal oxygen consumption and the workload achieved will be recorded.
Measured: 20 minutes
Secondary outcomes (5)
Respiratory muscle strength
Inspiratory and expiratory muscle strength will be measured with a mouth pressure measuring device. Measurements will be made in a sitting position with the hip and knee at 90 degrees and the trunk upright.
Measured: 8 minutes
Peripheral muscle strength
It will be evaluated with a portable manual muscle strength measuring device. Muscle strength of knee extensors will be measured. The measurement will be performed with the patient sitting with his/her back unsupported and his/her hands crossed on his/her chest.
Measured: 5 minutes
Grip strength
It will be evaluated with a portable hand dynamometer. Measurements will be made in a sitting position with the hip and knee at 90 degrees and the trunk upright. The measurement will be performed with the arm adjacent to the side of the trunk and the forearm parallel to the ground.
Measured: 3 minutes
Kinesiophobia
Tampa Kinesiophobia Scale will be used. A total of 17 questions will be answered in 4-point Likert form. In total, the patient scores between 17-68. A high score indicates high kinesiophobia.
Measured: 3 minutes
Quality of Life (symptoms, mood, activity limitation, environmental exposure)
Asthma Quality of Life Scale will be used for the evaluation. This scale consists of 4 sub-headings including symptoms, mood, activity limitation, environmental exposure and 32 questions. Each item is scored between 1-7. The total score of the scale is calculated by averaging the scores given to the items. The higher the score, the better the quality of life.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Mar 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
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.
- More trials run by Hacettepe UniversityThe 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-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aydan Aslı Aksel Uylar, Hacettepe University
- Investigators
- Naciye Vardar Yagli, Study director, Hacettepe UniversityMelda Saglam, Study chair, Hacettepe UniversityEbru Damadoglu, Study chair, Hacettepe UniversityMerve Firat, Study chair, Kirsehir Ahi Evran UniversitesiAydan Aslı Aksel Uylar, Principal investigator, Hacettepe UniversityMelek Cihanbeylerden, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449573
- Sponsor's protocol ID
- GO 23/533
- Status last verified
- Aug 2024
- First submitted
- 3 Mar 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiopulmonary Parameters in Individuals With Asthma
- ClinicalTrials.gov ID
- NCT06449573
- Acronym / sponsor ID
- GO 23/533
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 10 Jun 2024 (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 the study compare the cardiopulmonary parameters of individuals with asthma with healthy subjects.
Detailed description
It is thought that aerobic capacity of asthmatic individuals decreases due to chronic respiratory disease, especially oxygen consumption. Detailed investigation will be provided with this research.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | Other: Exercise capacityInclusion Criteria: * Patients receiving step 5 asthma treatment * 18-65 years * Asthma under control (asthma control test ≥20) * No more than 2 exacerbations in the last 1 year Exclusion Criteria: * Non-consenting * Patients with asthma exacerbation requiring systemic steroid use for at least 3 days in the last 1 month * Being an active smoker |
| Healthy Individuals | – | Other: Exercise capacityInclusion Criteria: * No respiratory, cardiovascular and metabolic diseases * Regular non-smoker Exclusion Criteria: * Non-consenting * Pregnant women |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include asthma patients followed up by Hacettepe University Faculty of Medicine, Department of Chest Diseases, Immunology and Allergy Branch and healthy individuals.
Key inclusion criteria (2 listed)
- No respiratory, cardiovascular and metabolic diseases
- Regular non-smoker
Key exclusion criteria (2 listed)
- Non-consenting
- Pregnant women
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 capacitycardiopulmonary exercise test used assessment of exercise capacity | Other | Asthma, Healthy Individuals |
Primary outcome
Exercise capacity
Time frame: 20 minutes
Exercise capacity will be assessed by Cardiopulmonary Exercise Test. The test will be performed on a bicycle ergometer. The test will be terminated when the target heart rate is reached or when the patient indicates that they are unable to continue the test. maximal oxygen consumption and the workload achieved will be recorded.
5 secondary outcomes
Respiratory muscle strength
Time frame: 8 minutes
Peripheral muscle strength
Time frame: 5 minutes
Grip strength
Time frame: 3 minutes
Kinesiophobia
Time frame: 3 minutes
Quality of Life (symptoms, mood, activity limitation, environmental exposure)
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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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.
Naciye Vardar Yagli study director
Hacettepe University
Melda Saglam study chair
Hacettepe University
Ebru Damadoglu study chair
Hacettepe University
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 Asthma, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 2 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: status not confirmed, as of the sponsor's last update on 27 Aug 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aydan Aslı Aksel Uylar (+90312 ext. 3051576, aydanaaksel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: 20 minutes). 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 27 Aug 2024.