NCT07175844

Brief Summary

The goal of this randomized clinical trial is to investigate whether vocal exercises or breathing exercises improve respiratory function and trunk stability in healthy adult women aged 18-65. The main questions it aims to answer are: Do vocal exercises improve respiratory function, respiratory muscle strength, endurance, and trunk stability? Do breathing exercises improve respiratory function, respiratory muscle strength, and endurance? Researchers will compare the vocal exercises group to the breathing exercises group to determine if one intervention has a superior effect on lung function, respiratory muscle performance, and trunk stability. Participants will: Perform a 6-week program of either vocal exercises or breathing exercises, with sessions twice per week, 30 minutes each. Complete pre- and post-intervention assessments including thoracic excursion, breath-hold tests, spirometry, Dynamic Neuromuscular Stabilization (DNS) tests, and trunk stability tests using the Stabilizer pressure biofeedback device. Engage with instructional videos and guidance through a closed social media group, allowing questions and feedback to ensure correct technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

December 10, 2024

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

2 days

First QC Date

September 2, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

womenvocal exercisesbreathing exercisescore stabilityspirometry

Outcome Measures

Primary Outcomes (5)

  • Forced expiratory volume (FEV₁)

    Forced expiratory volume (FEV₁) was measured in liters in one second (L/s) using the Contec Spirometer SP80B. Three trials were performed per participant, with the mean used for analysis.

    6 weeks

  • Stange test

    The Stange test (breath-hold after maximal inhalation) was performed in a seated position. Before testing, participants were instructed to breathe calmly, and breath-hold duration (in seconds) was recorded using a stopwatch.

    6 weeks

  • Forced vital capacity (FVC)

    Forced vital capacity (FVC) was measured in liters (L) with Contec Spirometer SP80B. Three trials were performed per participant, with the mean used for analysis.

    6 weeks

  • Peak expiratory flow (PEF)

    Peak expiratory flow (PEF) was measured in liters per one second (L/s) using the Contec Spirometer SP80B. Three trials were performed per participant, with the mean used for analysis.

    6 weeks

  • Genchi test

    The Genchi test (breath-hold after maximal exhalation) waas performed in a seated position. Before testing, participants were instructed to breathe calmly, and breath-hold duration (in seconds) was recorded using a stopwatch.

    6 weeks

Secondary Outcomes (2)

  • Dynamic Neuromuscular Stabilization (DNS)

    6 weeks

  • Trunk Stability Tests

    6 weeks

Study Arms (2)

VE group

EXPERIMENTAL

Participants performed six weekly sessions of 30 minutes, guided by videos focusing on diaphragmatic breathing and contemporary singing techniques. Initial exercises (weeks 1-2) included sustained "s" sounds, lip trills, humming, melodic vowel sequences, and "Ja" exercises. Weeks 3-6 included advanced solo exercises such as short and long "S", humming variations, "mum" vocalizations, rhythmic patterns ("cha-cha-cha"), melodic sequences ("Niemak 1-3"), and counting exercises. Exercises were performed standing, preferably in front of a mirror.

Other: Vocal exercises

BE group

ACTIVE COMPARATOR

Participants in the breathing exercises group were given access to a 30-minute instructional video, in which a licensed physiotherapist demonstrated how to perform the exercises. Participants were instructed to complete the exercises twice per week at a time convenient for them. They could reflect on the exercises and submit questions to the physiotherapist within a closed social media group. Two weeks after the start of the intervention, participants were advised to increase the intensity of the exercises: lengthening inhalation, exhalation, and breath-holding during square breathing, and increasing the number of exhalations during "Kapalabhati" breathing from 20 to 60 per series, while respecting individual comfort and tolerance.

Other: Breathing exercises

Interventions

Participants performed six weekly sessions of 30 minutes, guided by videos focusing on diaphragmatic breathing and contemporary singing techniques. Initial exercises (weeks 1-2) included sustained "s" sounds, lip trills, humming, melodic vowel sequences, and "Ja" exercises. Weeks 3-6 included advanced solo exercises such as short and long "S", humming variations, "mum" vocalizations, rhythmic patterns ("cha-cha-cha"), melodic sequences ("Niemak 1-3"), and counting exercises. Exercises were performed standing, preferably in front of a mirror.

VE group

Participants in the breathing exercises group were given access to a 30-minute instructional video, in which a licensed physiotherapist demonstrated how to perform the exercises. Participants were instructed to complete the exercises twice per week at a time convenient for them. They could reflect on the exercises and submit questions to the physiotherapist within a closed social media group. Two weeks after the start of the intervention, participants were advised to increase the intensity of the exercises: lengthening inhalation, exhalation, and breath-holding during square breathing, and increasing the number of exhalations during "Kapalabhati" breathing from 20 to 60 per series, while respecting individual comfort and tolerance.

BE group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female sex;
  • age 18-65 years;
  • no engagement in breathing exercises for at least six months;
  • no engagement in vocal training for at least six months;

You may not qualify if:

  • acute respiratory diseases.
  • chronic respiratory diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Health Promotion and Rehabilitation

Kaunas, Lithuania, LT - 44221, Lithuania

Location

Lithuanian Sports University

Kaunas, Lithuania, LT - 44221, Lithuania

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Eirida S Kudirkienė, MSc

    Lithuanian Sports University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2025

First Posted

September 16, 2025

Study Start

December 10, 2024

Primary Completion

December 12, 2024

Study Completion

May 1, 2025

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations