NCT07459153

Brief Summary

This study were to investigate the effects of multiple breathing training on pulmonary function, respiratory muscle strength, chest expansion, fractional exhaled nitric oxide (FeNO), aerobic capacity, and dyspnea symptoms in older adults.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 4, 2026

Last Update Submit

March 4, 2026

Conditions

Keywords

Multiple breathing trainingPulmonary functionRespiratory muscle strengthChest ExpansionFractional Exhaled Nitric Oxide

Outcome Measures

Primary Outcomes (5)

  • Forced Vital Capacity; FVC

    Participants were seated in a chair and wore a nasal clip during the assessment. They first performed three cycles of slow, normal breathing, followed by a demonstration of forced inspiration and expiration, and then returned to normal breathing.

    Change from Baseline FVC at 8 weeks.

  • Forced Expiratory Volume in One second; FEV1

    Participants were seated in a chair and wore a nasal clip during the assessment. They first performed three cycles of slow, normal breathing, followed by a demonstration of forced inspiration and expiration, and then returned to normal breathing.

    Change from Baseline FEV1 at 8 weeks.

  • Maximum Voluntary Ventilation; MVV

    Participants were instructed to breathe in and out as quickly and forcefully as possible for 15 seconds.

    Change from Baseline MVV at 8 weeks.

  • Maximal Inspiratory Pressure; MIP

    Participants were instructed to exhale fully to functional residual capacity (FRC), then place the mouthpiece securely and perform a maximal inspiratory effort sustained for 1-2 seconds.

    Change from Baseline MIP at 8 weeks.

  • Maximal expiratory pressure; MEP

    Participants inhaled fully to total lung capacity (TLC), maintained a tight seal on the mouthpiece, and then performed a maximal expiratory effort for 1-2 seconds.

    Change from Baseline MEP at 8 weeks.

Secondary Outcomes (4)

  • Chest expansion

    Change from Baseline Chest expansion at 8 weeks.

  • Fraction exhaled nitric oxide; FeNO

    Change from Baseline FeNO at 8 weeks.

  • Six minutes walk test (6MWT)

    Change from Baseline 6MWT at 8 weeks.

  • The University of California, SanDiego Shorthess of Breath Questionnaire (SOBQ)

    Change from Baseline SOBQ at 8 weeks.

Study Arms (2)

Multiple breathing training

EXPERIMENTAL

The multiple breathing training program consisted of five structured breathing exercises designed to improve inspiratory muscle strength, expiratory muscle strength, and breath control. Each exercise was performed for three sets, and the total training duration was approximately 40 minutes per session. The program included the following components: Inspiratory Muscle Training (PowerBreathe device): Participants performed resisted inhalation to strengthen the inspiratory muscles (10 repetitions per set). Expiratory Muscle Training (Balloon with control device): Participants exhaled into a balloon while maintaining pressure according to their measured maximal expiratory pressure (MEP) (10 repetitions per set). Inspiratory Training (Tri-Flow device): Participants inhaled through the device to elevate and maintain the floating balls, promoting sustained inspiratory effort (10 repetitions per set). Expiratory Training (Windmill device): Participants exhaled to rotate the windmill,

Other: Multiple breathing training

Control group (Normal daily life)

NO INTERVENTION

Interventions

The multiple breathing training program consisted of five structured breathing exercises designed to improve inspiratory muscle strength, expiratory muscle strength, and breath control. Each exercise was performed for three sets, and the total training duration was approximately 40 minutes per session. The program included the following components: Inspiratory Muscle Training (PowerBreathe device): Participants performed resisted inhalation to strengthen the inspiratory muscles (10 repetitions per set). Expiratory Muscle Training (Balloon with control device): Participants exhaled into a balloon while maintaining pressure according to their measured maximal expiratory pressure (MEP) (10 repetitions per set). Inspiratory Training (Tri-Flow device): Participants inhaled through the device to elevate and maintain the floating balls, promoting sustained inspiratory effort (10 repetitions per set). Expiratory Training (Windmill device): Participants exhaled to rotate the windmill, e

Multiple breathing training

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older adults aged 60-75 years, both male and female.
  • Not regularly physically active (exercising fewer than 2 times per week) during the 6 months prior to the study.
  • Cooperative, without communication problems, and able to follow instructions from the trainer.
  • No history of cardiovascular disease and no respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), etc.
  • No hypertension, or if diagnosed with hypertension, it must be well controlled, with resting blood pressure not exceeding 140 mmHg systolic and 90 mmHg diastolic.
  • Able to ambulate independently without assistance or assistive devices.
  • Willing to participate in the study and able to provide written informed consent.

You may not qualify if:

  • Any unforeseen events preventing continued participation in the study, such as injury from an accident or illness.
  • Attendance of less than 80% of the training sessions (fewer than 19 out of 24 sessions, including the basic training period).
  • Withdrawal of consent or unwillingness to continue participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sports Science, Chulalongkorn University

Bangkok, Bangkok, 10330, Thailand

Location

Related Publications (5)

  • Jansang S, Mickleborough T, Suksom D. Effects of Pursed-Lip Breathing Exercise Using Windmill Toy on Lung Function and Respiratory Muscle Strength in the Elderly. J Med Assoc Thai. 2016 Sep;99(9):1046-51.

    PMID: 29927211BACKGROUND
  • Jun HJ, Kim KJ, Nam KW, Kim CH. Effects of breathing exercises on lung capacity and muscle activities of elderly smokers. J Phys Ther Sci. 2016 Jun;28(6):1681-5. doi: 10.1589/jpts.28.1681. Epub 2016 Jun 28.

    PMID: 27390394BACKGROUND
  • Gosselink R. Breathing techniques in patients with chronic obstructive pulmonary disease (COPD). Chron Respir Dis. 2004;1(3):163-72. doi: 10.1191/1479972304cd020rs.

    PMID: 16281658BACKGROUND
  • Chung Y, Huang TY, Liao YH, Kuo YC. 12-Week Inspiratory Muscle Training Improves Respiratory Muscle Strength in Adult Patients with Stable Asthma: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Mar 22;18(6):3267. doi: 10.3390/ijerph18063267.

    PMID: 33809922BACKGROUND
  • Hess A, Yu L, Klein I, De Mazancourt M, Jebrak G, Mal H, Brugiere O, Fournier M, Courbage M, Dauriat G, Schouman-Clayes E, Clerici C, Mangin L. Neural mechanisms underlying breathing complexity. PLoS One. 2013 Oct 3;8(10):e75740. doi: 10.1371/journal.pone.0075740. eCollection 2013.

    PMID: 24098396BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 9, 2026

Study Start

November 1, 2025

Primary Completion

March 30, 2026

Study Completion

March 30, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations