NCT04280419

Brief Summary

This study aims to investigate the effect of music as an environmental factor on respiratory muscle endurance in healthy individuals.

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
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 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

February 28, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

May 29, 2019

Last Update Submit

February 20, 2020

Conditions

Keywords

Motivational Musicrespiratory muscle enduranceperceived exertion

Outcome Measures

Primary Outcomes (1)

  • Respiratory muscle endurance test

    Primary Outcome Measure: 1.Respiratory muscle endurance test In our study, the muscle endurance test at the fixed threshold load with 24-hour intervals, and the muscle endurance test at the increased threshold load will be performed. Test times will be calculated and calculated in seconds. The result values will be obtained by multiplying the test time and the pressure value corresponding to the time. In the fixed threshold load, the respiratory muscle endurance test will be performed in 60% of the MIP. For testing, the nose will be closed with a clip after the device is placed in the mouth. The respiratory muscle endurance test will be started with 20% of the MIP in the increased threshold load. The pressure will be increased to 40%, 60%, 80%, and 100% respectively in two minutes intervals. The pressure change and the measurements made in this order shall be made without removing the device from the mouth. For testing, the nose will be closed with a clip after the device is placed.

    1st 2 days

Study Arms (1)

Healty Subjects

Healthy Subjects Twenty-five healthy individuals will be included in the study. Physical properties of cases will be recorded. Respiratory functions and respiratory muscle strength will be evaluated. Physical activity will be assessed using the International Physical Activity Survey (IPAQ). Respiratory muscle endurance will be evaluated using an incremental workload test and fixed threshold load test. Tests will be repeated three times as motivational music, slow-paced music, and music. Heart rate, respiratory frequency, perceived exertion will be evaluated before and after the test.

Eligibility Criteria

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

Healthy Subjects

You may qualify if:

  • Being 18-35 years old.
  • Volunteer to participate in the study.
  • Without any health problems.
  • To be cooperative with the tests to be done.

You may not qualify if:

  • To have an orthopedic, neurological, chronic cardiovascular, pulmonary, and systemic disease to prevent the tests from being performed.
  • To have a visual, auditory, or cognitive problem.
  • Not willing to participate in the study.
  • To have previous experience in music and instruments used in the study.
  • In the last three months, there is no history of exercise training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Caner Acartürk, MSc

CONTACT

Deniz İNAL İNCE, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

May 29, 2019

First Posted

February 21, 2020

Study Start

February 28, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

February 21, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations