A Community-Based Swimming and Inspiratory Muscle Training Intervention to Promote Physical Activity and Asthma Control in Children With Mild Asthma (IMT-SWIM-ASTHM)

August 7, 2026 updated by: Coşkun YILMAZ, Gümüşhane Universıty
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Asthma-related airway obstruction and respiratory muscle dysfunction may limit exercise tolerance and disease control in children. Swimming is considered a safe and beneficial exercise modality for pediatric asthma due to its humid environment and controlled breathing patterns. Inspiratory muscle training specifically targets respiratory muscle weakness and may further enhance pulmonary adaptations. This parallel-group randomized controlled trial examined whether combining IMT with swimming training yields superior improvements in lung function, respiratory muscle strength, ventilatory capacity, perceived exertion, and asthma control compared with swimming training alone. The intervention lasted four weeks, with objective pulmonary and respiratory muscle assessments conducted pre- and post-intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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.
Other: 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.
Other: Swimming + Inspiratory Muscle Training (Experimental Group)
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.
Experimental: Swimming + Inspiratory Muscle Training (Experimental Group)
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)
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 + Inspiratory Muscle Training (Experimental Group)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximal Inspiratory Pressure (MIP)
Time Frame: 4 weeks
Measured using a handheld respiratory pressure device to assess inspiratory muscle strength.
4 weeks
Forced Expiratory Volume in 1 Second (FEV₁)
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum Voluntary Ventilation (MVV)
Time Frame: 4 week
Assessed via spirometry to evaluate pulmonary function. Maximum Voluntary Ventilation (MVV)
4 week
Peak Expiratory Flow (PEF)
Time Frame: 4 week
Assessed via spirometry to evaluate pulmonary function. Peak Expiratory Flow (PEF)
4 week
Forced Vital Capacity (FVC)
Time Frame: 4 week
Assessed via spirometry to evaluate pulmonary function. Forced Vital Capacity (FVC)
4 week
Rating of Perceived Exertion (Borg Scale)
Time Frame: 4 week
Rating of Perceived Exertion (Borg Scale), The Borg Rating of Perceived Exertion Scale (Borg Scale; 6-20) is a validated and reliable measure used to assess the level of exertion individuals perceive during exercise or physical activity over the past 4 weeks. Scale scores range from 6 to 20, with higher scores indicating a higher level of perceived exertion and, consequently, a poorer outcome.
4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gümüşhane Universıty

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Coşkun YILMAZ, associate professor, Gümüşhane Universıty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 25, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026/024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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