NCT06745869

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

December 10, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

December 23, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

December 10, 2024

Last Update Submit

February 20, 2025

Conditions

Keywords

SingingRespiratory Function TestsVoiceDiaphragmExercise, aerobic

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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

    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.

    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

    This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.

  • Vocal fatigue

    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

    This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.

  • Voice performance

    This outcome will be evaluated twice: before starting the exercise program and after implementing the exercise program for 8 weeks.

Study Arms (3)

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.

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.

Behavioral: Diaphragmatic breathing exercise trainingBehavioral: 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.

Interventions

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 training groupdiaphragmatic breathing exercise training group

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.

aerobic exercise training group

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Choric Culture Association

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ayşe Nur TUNALI VAN DEN BERG, Prof.

    İstanbul Medipol University

    STUDY CHAIR
  • Sıla YILMAZ, PhD (c.)

    İstanbul Medipol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sıla YILMAZ, PhD (c.)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The researcher who evaluated the analysis, and the participants are blind to the study
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A randomized-controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 10, 2024

First Posted

December 20, 2024

Study Start

December 23, 2024

Primary Completion

May 31, 2025

Study Completion

July 1, 2025

Last Updated

February 24, 2025

Record last verified: 2025-02

Locations