Asthma ControlIMT-SWIM-ASTHMNCT07394127
A Community-Based Swimming and Inspiratory Muscle Training Intervention to Promote Physical Activity and Asthma Control in Children With Mild Asthma
A study testing Swimming + Inspiratory Muscle Training (Experimental Group) in people with Asthma Control and Asthma, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Asthma Control, Asthma, Asthma Chronic
- What is being tested?
- Swimming + Inspiratory Muscle Training (Experimental Group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2026to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gumushane Univetsity
Gümüşhane, Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane, 29600
About this study
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.
Read the 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.
- Conditions
- Asthma Control, Asthma, Asthma Chronic
- Being tested
- Swimming Training Only (Control Group), Swimming + Inspiratory Muscle Training (Experimental Group)
- Keywords
- asthma control, pulmonary function, swimming, inspiratory muscle training, children, asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Swimming + Inspiratory Muscle Training (Experimental Group)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Swimming Training Only (Control Group); Other: Swimming + Inspiratory Muscle Training (Experimental Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure (MIP)
Measured using a handheld respiratory pressure device to assess inspiratory muscle strength.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (4)
Rating of Perceived Exertion (Borg Scale)
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.
Measured: 4 week
Maximum Voluntary Ventilation (MVV)
Assessed via spirometry to evaluate pulmonary function. Maximum Voluntary Ventilation (MVV)
Measured: 4 week
Peak Expiratory Flow (PEF)
Assessed via spirometry to evaluate pulmonary function. Peak Expiratory Flow (PEF)
Measured: 4 week
Forced Vital Capacity (FVC)
Assessed via spirometry to evaluate pulmonary function. Forced Vital Capacity (FVC)
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start15 Feb 2026
- Primary completion25 Feb 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Model Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gümüşhane Universıty
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Coşkun YILMAZ, Gümüşhane Universıty
- Investigators
- Coşkun YILMAZ, associate professor, Principal investigator, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394127
- Sponsor's protocol ID
- 2026/024
- Acronym
- IMT-SWIM-ASTHM
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-Based Swimming and Inspiratory Muscle Training Intervention to Promote Physical Activity and Asthma Control in Children With Mild Asthma
- ClinicalTrials.gov ID
- NCT07394127
- Acronym / sponsor ID
- IMT-SWIM-ASTHM / 2026/024
- Conditions
- Asthma Control, Asthma, Asthma Chronic
- Keywords
- asthma control, pulmonary function, swimming, inspiratory muscle training, children, asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gümüşhane UniversıtyUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention Model Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Swimming Training Only (Control Group) | Other | Other: Swimming Training Only (Control Group), Other: Swimming + Inspiratory Muscle Training (Experimental 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) | Experimental | Other: Swimming Training Only (Control Group), 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. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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), Swimming Training Only (Control Group) |
| 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 + Inspiratory Muscle Training (Experimental Group), Swimming Training Only (Control Group) |
Primary outcome
Maximal Inspiratory Pressure (MIP)
Time frame: 4 weeks
Measured using a handheld respiratory pressure device to assess inspiratory muscle strength.
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.
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 secondary outcomes
Rating of Perceived Exertion (Borg Scale)
Time frame: 4 week
Maximum Voluntary Ventilation (MVV)
Time frame: 4 week
Peak Expiratory Flow (PEF)
Time frame: 4 week
Forced Vital Capacity (FVC)
Time frame: 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Coşkun YILMAZ, associate professor principal investigator
Gümüşhane Universıty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swimming + Inspiratory Muscle Training (Experimental Group) in people with Asthma Control and Asthma, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Inspiratory Pressure (MIP) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.