Respiratory ProblemsNCT04208022
The Effect of Hypermobility Healthy Individuals
An observational study of Respiratory Problems, run by Istanbul Kültür University at 1 site in Turkey (Türkiye).
Trial summary
Benign Joint Hypermobility Syndrome is a hereditary connective tissue problem characterized by the emergence of multiple musculoskeletal problems in hypermobile individuals without a systemic rheumatologic disease. Studies have shown that hypermobility may also affect lung function. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Problems
- What is being tested?
- Respiratory evaluation
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 30 Dec 2020
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The musicians who meet the criteria for inclusion in the study and who play the wind instrument who agree to voluntarily participate in the study and healthy individuals who are not interested in music will be included.
Who may be able to join
- Be between 18-35 years Playing wind instruments for at least one year For the hypermobile subgroup; Obtaining ≥7 / 12 points from the Upper Extremity Hypermobility Assessment Questionnaire
- Inclusion Criteria for Healthy Individuals Not Engaged in Music
- Be between 18-35 years No diagnosed health problems For the hypermobile subgroup; Obtaining ≥7 / 12 points from the Upper Extremity Hypermobility Assessment Questionnaire
Who cannot join
- Having a specific respiratory problem diagnosed Symptoms of nerve impingement in upper extremity Smoking
- Exclusion Criteria for Healthy Individuals Not Engaged in Music
- Symptoms of nerve impingement in upper extremity Smoking
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Kultur University
Istanbul, E5 Highway Bakırköy, İstanbul, 34158
Karaca, 0546 874 4530, karacagulsah92@gmail.com
Esra Pehlivan, Asst.Prof.Dr
About this study
Official title: The Effect of Hypermobility on Respiratory Functions in Musicians Playing Wind Instruments and Healthy Individuals Not Involved in Music
Benign Joint Hypermobility Syndrome is a hereditary connective tissue problem characterized by the emergence of multiple musculoskeletal problems in hypermobile individuals without a systemic rheumatologic disease. Studies have shown that hypermobility may also affect lung function. Playing wind instruments requires tiring breathing activity. The effect of wind instrument on lung function and how it affects lung function is a highly controversial issue. Given the distribution and importance of collagen tissue in the body, multiple effects of hypermobility are inevitable. The aim of this study was to evaluate the presence of hypermobility in young healthy individuals; The aim of the study is to investigate the effects of hypermobility on the cardiovascular system and to provide training to the participants regarding the findings.The aim of this study is to investigate the relationship of hypermobility with respiratory functions in professional hypermobile musicians and to compare this relationship with healthy hypermobile individuals who are not engaged in music.
Read the detailed description
Sociodemographic data and musical backgrounds of all cases will be recorded. In accordance with the objectives, erm Upper Extremity Hypermobility Assessment Questionnaire "was used for hypermobility, pulmonary function test, respiratory and oral pressure measurement and respiratory muscle strength. The George Respiratory Questionnaire (SGRQ) will be used to assess the quality of life associated with respiration and the risk of asthma with the ile European Respiratory Health Survey, Phase 1 "questionnaire.We believe that the effects of hypermobility on pulmonary functions in healthy individuals will be clarified if this study takes place.
- Conditions
- Respiratory Problems
- Being tested
- Respiratory evaluation
- Keywords
- Musicians, Respiratory, Hypermobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory evaluationOther
Hypermobility and Respiratory evaluation
| Study group | Role | What they receive |
|---|---|---|
| Healthy Musician | At least 15 hypermobile musicians and at least 15 non-hypermobile musicians will be included in the study. Receives: Other: Respiratory evaluation | |
| Healthy Individuals | The study will include at least 15 healthy non-hypermobile individuals who do not deal with music and at least 15 healthy hypermobile individuals who do not deal with music. Receives: Other: Respiratory evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Upper Limb Hypermobility Assessment Tool
Hypermobility
Measured: 10 minutes
St. George Respiratory Questionnaire
respiratory quality
Measured: 5 minutes
European Respiratory Health Survey, Phase 1
assess the risk of asthma
Measured: 5 minutes
Respiratory function test
FEV1,FVC
Measured: 15minutes
mouth pressure measurement
MIP, MEP
Measured: 15minutes
Secondary outcomes (1)
Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians
Pain
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 posted23 Dec 2019
- Study start1 Aug 2019
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory ProblemsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Kültür University
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Gülşah Karaca, Istanbul Kültür University
- Investigators
- Esra Pehlivan, Asst.Prof.Dr, Principal investigator, Saglik Bilimleri UniversitesiGulsah Karaca, Researcher, Principal investigator, Istanbul Kültür University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208022
- Sponsor's protocol ID
- IstanbulKulturU
- Status last verified
- Feb 2020
- First submitted
- 16 Dec 2019
- Last updated
- 10 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hypermobility on Respiratory Functions in Musicians Playing Wind Instruments and Healthy Individuals Not Involved in Music
- ClinicalTrials.gov ID
- NCT04208022
- Acronym / sponsor ID
- IstanbulKulturU
- Conditions
- Respiratory Problems
- Keywords
- Musicians, Respiratory, Hypermobility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Kültür UniversityUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 23 Dec 2019 (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.
Benign Joint Hypermobility Syndrome is a hereditary connective tissue problem characterized by the emergence of multiple musculoskeletal problems in hypermobile individuals without a systemic rheumatologic disease. Studies have shown that hypermobility may also affect lung function. Playing wind instruments requires tiring breathing activity. The effect of wind instrument on lung function and how it affects lung function is a highly controversial issue. Given the distribution and importance of collagen tissue in the body, multiple effects of hypermobility are inevitable. The aim of this study was to evaluate the presence of hypermobility in young healthy individuals; The aim of the study is to investigate the effects of hypermobility on the cardiovascular system and to provide training to the participants regarding the findings.The aim of this study is to investigate the relationship of hypermobility with respiratory functions in professional hypermobile musicians and to compare this relationship with healthy hypermobile individuals who are not engaged in music.
Detailed description
Sociodemographic data and musical backgrounds of all cases will be recorded. In accordance with the objectives, erm Upper Extremity Hypermobility Assessment Questionnaire "was used for hypermobility, pulmonary function test, respiratory and oral pressure measurement and respiratory muscle strength. The George Respiratory Questionnaire (SGRQ) will be used to assess the quality of life associated with respiration and the risk of asthma with the ile European Respiratory Health Survey, Phase 1 "questionnaire.We believe that the effects of hypermobility on pulmonary functions in healthy individuals will be clarified if this study takes place.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Musician | – | Other: Respiratory evaluationAt least 15 hypermobile musicians and at least 15 non-hypermobile musicians will be included in the study. |
| Healthy Individuals | – | Other: Respiratory evaluationThe study will include at least 15 healthy non-hypermobile individuals who do not deal with music and at least 15 healthy hypermobile individuals who do not deal with music. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The musicians who meet the criteria for inclusion in the study and who play the wind instrument who agree to voluntarily participate in the study and healthy individuals who are not interested in music will be included.
Key inclusion criteria (3 listed)
- Be between 18-35 years Playing wind instruments for at least one year For the hypermobile subgroup; Obtaining ≥7 / 12 points from the Upper Extremity Hypermobility Assessment Questionnaire
- Inclusion Criteria for Healthy Individuals Not Engaged in Music
- Be between 18-35 years No diagnosed health problems For the hypermobile subgroup; Obtaining ≥7 / 12 points from the Upper Extremity Hypermobility Assessment Questionnaire
Key exclusion criteria (3 listed)
- Having a specific respiratory problem diagnosed Symptoms of nerve impingement in upper extremity Smoking
- Exclusion Criteria for Healthy Individuals Not Engaged in Music
- Symptoms of nerve impingement in upper extremity Smoking
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 |
|---|---|---|
| Respiratory evaluationHypermobility and Respiratory evaluation | Other | Healthy Individuals, Healthy Musician |
Primary outcome
The Upper Limb Hypermobility Assessment Tool
Time frame: 10 minutes
Hypermobility
St. George Respiratory Questionnaire
Time frame: 5 minutes
respiratory quality
European Respiratory Health Survey, Phase 1
Time frame: 5 minutes
assess the risk of asthma
Respiratory function test
Time frame: 15minutes
FEV1,FVC
mouth pressure measurement
Time frame: 15minutes
MIP, MEP
1 secondary outcome
Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians
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 10 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Esra Pehlivan, Asst.Prof.Dr principal investigator
Saglik Bilimleri Universitesi
Gulsah Karaca, Researcher principal investigator
Istanbul Kültür 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 Respiratory Problems, run by Istanbul Kültür 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 3 inclusion and 3 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 10 Feb 2020. 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 Karaca (05468744530, karacagulsah92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Upper Limb Hypermobility Assessment Tool (time frame: 10 minutes). The study lists 5 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 10 Feb 2020.