Respiratory MusclesNCT06745869
Effects of Aerobic and Diaphragmatic Exercises on Choir Singers
A study testing Diaphragmatic breathing exercise training and Aerobic exercise training in people with Respiratory Muscles and Cardiorespiratory Fitness, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized-controlled study is to compare the effects of diaphragmatic breathing exercise training provided by a physiotherapist and aerobic exercise training applied in addition to diaphragmatic breathing exercise training provided by a physiotherapist on respiratory functions and voice performance… Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Muscles, Cardiorespiratory Fitness
- What is being tested?
- Diaphragmatic breathing exercise training and Aerobic exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Dec 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a chorist in an active choir that rehearses at least once a week for an average of 2 hours
- Having an inactive or minimally active physical activity level according to the International Physical Activity Questionnaire-Short Form
- Being between the ages of 25-60
- Being willing to participate in the study
Who cannot join
- Having a neurological or orthopedic disease
- Having a condition related to the cardiopulmonary system that would prevent exercise according to the Physical Activity Readiness Questionnaire (PAR-Q)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Choric Culture Association
Istanbul
Choric Culture Association, info@korokulturu.org
About this study
Official title: Effects of Aerobic and Diaphragmatic Breathing Exercises on Respiratory Functions and Voice Performance of Choir Singers
The goal of this randomized-controlled study is to compare the effects of diaphragmatic breathing exercise training provided by a physiotherapist and aerobic exercise training applied in addition to diaphragmatic breathing exercise training provided by a physiotherapist on respiratory functions and voice performance in choir singers.
The main questions this study aims to answer are:
Read more
- Is diaphragmatic breathing exercise training provided by a physiotherapist effective in improving the respiratory functions of choir singers?
- Is diaphragmatic breathing exercise training provided by a physiotherapist effective in improving the vocal performance of choir singers?
- Does aerobic exercise training applied in addition to diaphragmatic breathing exercise training provided by a physiotherapist have a greater effect on improving the respiratory functions of choir singers compared to diaphragmatic breathing exercise training applied alone?
- Does aerobic exercise training applied in addition to diaphragmatic breathing exercise training provided by a physiotherapist have a greater effect on improving the vocal performance of choir singers compared to diaphragmatic breathing exercise training applied alone?
The research data are going to be collected by Sociodemographic Information Form, International Physical Activity Questionnaire-Short Form, Self-Performance Evaluation Questionnaire, Vocal Fatigue Index, Singing Voice Handicap Index, measurement of maximum phonation time, pulmonary function test, maximal inspiratory and expiratory pressure measurement, and 6-minute walk test.
Read the detailed description
In this study, it will be examined whether aerobic exercise training applied in addition to diaphragmatic breathing exercise training provided by a physiotherapist improves respiratory functions and voice performance in choir singers more, when compared to diaphragmatic breathing exercise training applied alone.
The participants will be randomly divided into three groups: diaphragmatic breathing exercise training group, aerobic exercise training group applied in addition to diaphragmatic breathing exercise training, and control group.
- Conditions
- Respiratory Muscles, Cardiorespiratory Fitness
- Being tested
- Diaphragmatic breathing exercise training, Aerobic exercise training
- Keywords
- Singing, Respiratory Function Tests, Voice, Diaphragm, Exercise, aerobic
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic breathing exercise trainingBehavioural
At the end of the training, participants will be asked to do an exercise session and this session will be observed. Training will continue until participants learn and apply the exercise correctly.
5-minute warm-up and cool-down periods will be applied at the beginning and end of each exercise session. Exercises will be done twice a day, morning and evening, for 8 weeks.
In order to follow the exercise, participants will be given diaphragmatic breathing exercise tracking cards with date and session information. In addition, participants will be followed up weekly on one of the rehearsal days to ensure their adaptation to the exercise.
Aerobic exercise trainingBehavioural
The intensity of the aerobic exercise program will be calculated for each participant using the Karvonen formula. Accordingly, each participant will be given a brisk walking program on a suitable surface, which will be created specifically for the individual to reach the target heart rate range within the scope of the aerobic exercise program; they will apply a 45-minute session, 3 days a week, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| diaphragmatic breathing exercise training group | Active comparator | Participants included in the diaphragmatic breathing exercise training group will be provided diaphragmatic breathing training by a physiotherapist before starting the exercise program. Receives: Behavioral: Diaphragmatic breathing exercise training |
| aerobic exercise training group | Experimental | The protocol given to the diaphragmatic breathing exercise training group will also be included in the exercise program of participants included in the aerobic exercise training group. Receives: Behavioral: Diaphragmatic breathing exercise training; Behavioral: Aerobic exercise training |
| Control group | No intervention | Participants included in the control group will be asked to continue their daily routines without changing their lifestyles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1/FVC
Pulmonary function test with a spirometer will be performed on all participants to assess forced expiratory volume in 1 second and forced vital capacity.
Measured: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
Slow vital capacity
Pulmonary function test with a spirometer will be performed on all participants to assess slow vital capacity.
Measured: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
Maximal voluntary ventilation
Pulmonary function test with a spirometer will be performed on all participants to assess maximal voluntary ventilation.
Measured: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
Maximal inspiratory and expiratory pressure
An electronic respiratory pressure meter will be used to calculate maximal inspiratory and expiratory pressure
Measured: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
Maximum phonation time
Each participant will be asked to say the vowels "a, e, i, o, u" at their most comfortable pitch for as long as possible, and the time they can say them will be determined by a stopwatch.
Measured: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
Secondary outcomes (4)
Aerobic capacity and endurance
6 Minute Walk Test will be performed on all participants to assess aerobic capacity and endurance.
Measured: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
Vocal fatigue
Vocal Fatigue Index which is a self-report questionnaire for identifying individuals with vocal fatigue and characterizing their complaints will be used to assess the vocal fatigue of all participants.
Measured: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
Singing voice and voice-related problems
Singing Voice Handicap Index will be used to assess the voice-related handicaps of all participants.
Measured: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
Voice performance
The Self-Performance Evaluation Questionnaire, which is created by the researcher and is a scale in which the participant evaluates his/her own musical performance by scoring it between from 1 to 10, will be used to evaluate the performance.
Measured: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start23 Dec 2024
- Primary completion31 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory MusclesStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sıla YILMAZ, Medipol University
- Investigators
- Ayşe Nur TUNALI VAN DEN BERG, Prof., Study chair, İstanbul Medipol UniversitySıla YILMAZ, PhD (c.), Principal investigator, İstanbul Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745869
- Sponsor's protocol ID
- E-10840098-772.02-197
- Status last verified
- Feb 2025
- First submitted
- 10 Dec 2024
- Last updated
- 24 Feb 2025
- 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 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic and Diaphragmatic Breathing Exercises on Respiratory Functions and Voice Performance of Choir Singers
- ClinicalTrials.gov ID
- NCT06745869
- Acronym / sponsor ID
- E-10840098-772.02-197
- Conditions
- Respiratory Muscles, Cardiorespiratory Fitness
- Keywords
- Singing, Respiratory Function Tests, Voice, Diaphragm, Exercise, aerobic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 20 Dec 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 goal of this randomized-controlled study is to compare the effects of diaphragmatic breathing exercise training provided by a physiotherapist and aerobic exercise training applied in addition to diaphragmatic breathing exercise training provided by a physiotherapist on respiratory functions and voice performance in choir singers.
The main questions this study aims to answer are:
- Is diaphragmatic breathing exercise training provided by a physiotherapist effective in improving the respiratory functions of choir singers?
- Is diaphragmatic breathing exercise training provided by a physiotherapist effective in improving the vocal performance of choir singers?
- Does aerobic exercise training applied in addition to diaphragmatic breathing exercise training provided by a physiotherapist have a greater effect on improving the respiratory functions of choir singers compared to diaphragmatic breathing exercise training applied alone?
- Does aerobic exercise training applied in addition to diaphragmatic breathing exercise training provided by a physiotherapist have a greater effect on improving the vocal performance of choir singers compared to diaphragmatic breathing exercise training applied alone?
The research data are going to be collected by Sociodemographic Information Form, International Physical Activity Questionnaire-Short Form, Self-Performance Evaluation Questionnaire, Vocal Fatigue Index, Singing Voice Handicap Index, measurement of maximum phonation time, pulmonary function test, maximal inspiratory and expiratory pressure measurement, and 6-minute walk test.
Detailed description
In this study, it will be examined whether aerobic exercise training applied in addition to diaphragmatic breathing exercise training provided by a physiotherapist improves respiratory functions and voice performance in choir singers more, when compared to diaphragmatic breathing exercise training applied alone.
The participants will be randomly divided into three groups: diaphragmatic breathing exercise training group, aerobic exercise training group applied in addition to diaphragmatic breathing exercise training, and control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized-controlled trial
| Arm | Type | Receives |
|---|---|---|
| diaphragmatic breathing exercise training group | Active comparator | Behavioral: Diaphragmatic breathing exercise trainingParticipants included in the diaphragmatic breathing exercise training group will be provided diaphragmatic breathing training by a physiotherapist before starting the exercise program. |
| aerobic exercise training group | Experimental | Behavioral: Diaphragmatic breathing exercise training, Behavioral: Aerobic exercise trainingThe protocol given to the diaphragmatic breathing exercise training group will also be included in the exercise program of participants included in the aerobic exercise training group. |
| Control group | No intervention | –Participants included in the control group will be asked to continue their daily routines without changing their lifestyles. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being a chorist in an active choir that rehearses at least once a week for an average of 2 hours
- Having an inactive or minimally active physical activity level according to the International Physical Activity Questionnaire-Short Form
- Being between the ages of 25-60
- Being willing to participate in the study
Key exclusion criteria (2 listed)
- Having a neurological or orthopedic disease
- Having a condition related to the cardiopulmonary system that would prevent exercise according to the Physical Activity Readiness Questionnaire (PAR-Q)
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 |
|---|---|---|
| Diaphragmatic breathing exercise trainingAt the end of the training, participants will be asked to do an exercise session and this session will be observed. Training will continue until participants learn and apply the exercise correctly. 5-minute warm-up and cool-down periods will be applied at the beginning and end of each exercise session. Exercises will be done twice a day, morning and evening, for 8 weeks. In order to follow the exercise, participants will be given diaphragmatic breathing exercise tracking cards with date and session information. In addition, participants will be followed up weekly on one of the rehearsal days to ensure their adaptation to the exercise. | Behavioural | aerobic exercise training group, diaphragmatic breathing exercise training group |
| Aerobic exercise trainingThe intensity of the aerobic exercise program will be calculated for each participant using the Karvonen formula. Accordingly, each participant will be given a brisk walking program on a suitable surface, which will be created specifically for the individual to reach the target heart rate range within the scope of the aerobic exercise program; they will apply a 45-minute session, 3 days a week, for 8 weeks. | Behavioural | aerobic exercise training group |
Primary outcome
FEV1/FVC
Time frame: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
Pulmonary function test with a spirometer will be performed on all participants to assess forced expiratory volume in 1 second and forced vital capacity.
Slow vital capacity
Time frame: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
Pulmonary function test with a spirometer will be performed on all participants to assess slow vital capacity.
Maximal voluntary ventilation
Time frame: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
Pulmonary function test with a spirometer will be performed on all participants to assess maximal voluntary ventilation.
Maximal inspiratory and expiratory pressure
Time frame: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
An electronic respiratory pressure meter will be used to calculate maximal inspiratory and expiratory pressure
Maximum phonation time
Time frame: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
Each participant will be asked to say the vowels "a, e, i, o, u" at their most comfortable pitch for as long as possible, and the time they can say them will be determined by a stopwatch.
4 secondary outcomes
Aerobic capacity and endurance
Time frame: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
Vocal fatigue
Time frame: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
Singing voice and voice-related problems
Time frame: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
Voice performance
Time frame: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
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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.
Ayşe Nur TUNALI VAN DEN BERG, Prof. study chair
İstanbul Medipol University
Sıla YILMAZ, PhD (c.) principal investigator
İstanbul Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic breathing exercise training and Aerobic exercise training in people with Respiratory Muscles and Cardiorespiratory Fitness, run by Medipol 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 4 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: looking for participants now, as of the sponsor's last update on 24 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sıla YILMAZ, PhD (c.) (4448544, yilmazsila18@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1/FVC (time frame: This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.). 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 24 Feb 2025.