NCT04208022

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

December 16, 2019

Last Update Submit

February 7, 2020

Conditions

Keywords

MusiciansRespiratoryHypermobility

Outcome Measures

Primary Outcomes (5)

  • The Upper Limb Hypermobility Assessment Tool

    Hypermobility

    10 minutes

  • St. George Respiratory Questionnaire

    respiratory quality

    5 minutes

  • European Respiratory Health Survey, Phase 1

    assess the risk of asthma

    5 minutes

  • Respiratory function test

    FEV1,FVC

    15minutes

  • mouth pressure measurement

    MIP, MEP

    15minutes

Secondary Outcomes (1)

  • Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians

    10 minutes

Study Arms (2)

Healthy Musician

At least 15 hypermobile musicians and at least 15 non-hypermobile musicians will be included in the study.

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.

Other: Respiratory evaluation

Interventions

Hypermobility and Respiratory evaluation

Healthy IndividualsHealthy Musician

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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
  • Be between 18-35 years No diagnosed health problems For the hypermobile subgroup; Obtaining ≥7 / 12 points from the Upper Extremity Hypermobility Assessment Questionnaire

You may not qualify if:

  • Having a specific respiratory problem diagnosed Symptoms of nerve impingement in upper extremity Smoking
  • Symptoms of nerve impingement in upper extremity Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Kultur University

Istanbul, E5 Highway Bakırköy, İstanbul, 34158, Turkey (Türkiye)

RECRUITING

Study Officials

  • Esra Pehlivan, Asst.Prof.Dr

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR
  • Gulsah Karaca, Researcher

    Istanbul Kültür University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 16, 2019

First Posted

December 23, 2019

Study Start

August 1, 2019

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

February 10, 2020

Record last verified: 2020-02

Locations