NCT07394127

Brief Summary

This randomized controlled trial investigated the effects of adding inspiratory muscle training (IMT) to a structured swimming program on pulmonary function, respiratory muscle strength, ventilatory capacity, perceived exertion, and asthma control in children with mild persistent asthma. Thirty children aged 8-11 years were randomly assigned to either a swimming plus IMT group or a swimming-only group. Both groups participated in a supervised 4-week swimming program, while the experimental group additionally performed IMT twice daily. Pulmonary function tests, respiratory muscle strength, and Childhood Asthma Control Test (C-ACT) scores were assessed before and after the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

January 25, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

February 2, 2026

Last Update Submit

April 12, 2026

Conditions

Keywords

asthma controlpulmonary functionswimminginspiratory muscle trainingchildrenasthma

Outcome Measures

Primary Outcomes (3)

  • Maximal Inspiratory Pressure (MIP)

    Measured using a handheld respiratory pressure device to assess inspiratory muscle strength.

    4 weeks

  • Forced Expiratory Volume in 1 Second (FEV₁)

    Assessed via spirometry to evaluate pulmonary function. Forced expiratory volume in one second (FEV₁) was measured using the spirometry method to assess lung function. FEV₁ values were reported as a percentage of the predicted value (% predicted) based on reference values. While there is no theoretical minimum or maximum limit for the measurement, higher FEV₁ values indicate better pulmonary function.

    4 weeks

  • Childhood Asthma Control Test (C-ACT) Score

    Validated questionnaire assessing asthma symptom control in children. The Childhood Asthma Control Test (C-ACT) is a self-report questionnaire used to assess the level of asthma symptom control in children over the past 4 weeks, with proven validity and reliability. The total scale score ranges from 0 to 27, with higher scores indicating better asthma control.

    4 weeks

Secondary Outcomes (4)

  • Rating of Perceived Exertion (Borg Scale)

    4 week

  • Maximum Voluntary Ventilation (MVV)

    4 week

  • Peak Expiratory Flow (PEF)

    4 week

  • Forced Vital Capacity (FVC)

    4 week

Study Arms (2)

Swimming Training Only (Control Group)

OTHER

Participants completed a supervised swimming training program for 4 weeks, consisting of three 60-minute sessions per week. Sessions included warm-up, main swimming exercises, and cool-down breathing exercises. Exercise intensity was maintained at approximately 65% of maximal heart rate.

Other: Swimming Training Only (Control Group)Other: Swimming + Inspiratory Muscle Training (Experimental Group)

Swimming + Inspiratory Muscle Training (Experimental Group)

EXPERIMENTAL

Participants completed the same swimming training program as the control group. In addition, inspiratory muscle training was performed using a threshold pressure-loading device. IMT was conducted twice daily, starting at 30% of maximal inspiratory pressure and progressively increased by 5% weekly, over a 4-week period.

Other: Swimming Training Only (Control Group)Other: Swimming + Inspiratory Muscle Training (Experimental Group)

Interventions

Participants completed the same swimming training program as the control group. In addition, inspiratory muscle training was performed using a threshold pressure-loading device. IMT was conducted twice daily, starting at 30% of maximal inspiratory pressure and progressively increased by 5% weekly, over a 4-week period.

Swimming + Inspiratory Muscle Training (Experimental Group)Swimming Training Only (Control Group)

Participants completed a supervised swimming training program for 4 weeks, consisting of three 60-minute sessions per week. Sessions included warm-up, main swimming exercises, and cool-down breathing exercises. Exercise intensity was maintained at approximately 65% of maximal heart rate.

Swimming + Inspiratory Muscle Training (Experimental Group)Swimming Training Only (Control Group)

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 8-11 years
  • Clinically diagnosed mild persistent asthma according to GINA guidelines
  • Baseline FEV₁ ≥ 80% predicted
  • Stable asthma treatment for at least 4 weeks
  • Written informed consent from parents or guardians

You may not qualify if:

  • Mild intermittent, moderate, or severe persistent asthma
  • Acute asthma exacerbation during the study
  • Other chronic respiratory, cardiovascular, or neuromuscular diseases
  • Recent upper respiratory tract infection
  • Use of medications affecting pulmonary function other than standard asthma therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gumushane Univetsity

Gümüşhane, Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane, 29600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Asthma

Interventions

Control GroupsSwimming

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Coşkun YILMAZ, associate professor

    Gümüşhane Universıty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Intervention Model Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 6, 2026

Study Start

January 25, 2025

Primary Completion

February 25, 2025

Study Completion

February 28, 2025

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to ethical restrictions and the inclusion of pediatric participants. Data sharing was not explicitly included in the informed consent, and sharing raw data could compromise participant confidentiality.

Locations