- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07394127
Effects of Inspiratory Muscle Training Added to a Swimming Program in Children With Asthma (IMT-SWIM-ASTHM)
April 12, 2026 updated by: Coşkun YILMAZ, Gümüşhane Universıty
Effects of Inspiratory Muscle Training Combined With a Structured Swimming Program on Pulmonary Function and Asthma Control in Children With Mild Asthma: A Randomized Controlled Trial
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
Completed
Conditions
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
Interventional
Enrollment (Actual)
30
Phase
- 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
-
-
Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
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.
|
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.
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
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
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
Investigators
- 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)
January 25, 2025
Primary Completion (Actual)
February 25, 2025
Study Completion (Actual)
February 28, 2025
Study Registration Dates
First Submitted
February 2, 2026
First Submitted That Met QC Criteria
February 2, 2026
First Posted (Actual)
February 6, 2026
Study Record Updates
Last Update Posted (Actual)
April 15, 2026
Last Update Submitted That Met QC Criteria
April 12, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity, Immediate
- Hypersensitivity
- Asthma
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Exercise
- Locomotion
- Control Groups
- Swimming
Other Study ID Numbers
- 2025/024
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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