Inspiratory Muscle TrainingNCT07246655
Inspiratory Muscle Training in American Football Players
A study testing High-Intensity Inspiratory Muscle Training in people with Inspiratory Muscle Training, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the randomized controlled study is to investigate the effects of high-intensity inspiratory muscle training on respiratory strength, balance, and core endurance in American Football (Tackle Football) athletes. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inspiratory Muscle Training
- What is being tested?
- High-Intensity Inspiratory Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2025to 21 Jan 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-identified male American football athletes
- Ages 18 to 35 years
- Actively participating in team-based training at the time of study enrollment
- Minimum 1 year of organized American football training experience
- Able to perform high-intensity inspiratory muscle training (IMT)
- No history of acute respiratory infection in the past 4 weeks
- Voluntary agreement to participate and ability to provide informed consent
Who cannot join
- Acute or chronic respiratory disease (e.g., uncontrolled asthma, COPD)
- History of major cardiovascular, neurological, or musculoskeletal disorders affecting performance
- Current rib, spine, abdominal, or core muscle injury
- Diagnosed pulmonary hypertension or unstable cardiac conditions
- Recent surgery (within the past 3 months)
- Inability to correctly perform inspiratory muscle training (IMT) device technique
- Participation in another interventional study within the last 30 days
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tekirdağ Namık Kemal Univercity
Tekirdağ, Süleymanpaşa, 59100
About this study
Official title: Effects of High-Intensity Inspiratory Muscle Training on Respiratory Muscle Strength, Balance, and Core Endurance in American Football Players
The aim of the randomized controlled study is to investigate the effects of high-intensity inspiratory muscle training on respiratory strength, balance, and core endurance in American Football (Tackle Football) athletes.
Read the detailed description
After completing baseline assessments, participants will be randomly assigned to either the High-Intensity Inspiratory Muscle Training group (IMT Group) or the Control Group (CG) using simple randomization procedures.
All athletes in both groups will continue their regular team-based strength and conditioning routines throughout the 8-week study period. Participants in the IMT Group will additionally perform a high-intensity inspiratory muscle training protocol three times per week, with training loads set at approximately 80% of each athlete's measured maximal inspiratory pressure (MIP). Training intensity will be reassessed bi-weekly and adjusted according to updated MIP values to ensure that the prescribed load is maintained throughout the intervention. The Control Group will not receive inspiratory muscle training and will perform only their routine training program.
All athletes will be evaluated at baseline and at the end of the 8-week intervention. Outcome measures will include respiratory muscle strength (MIP/MEP), dynamic and static balance performance, core muscle endurance (McGill core endurance tests), and sport-specific performance parameters relevant to American football. Assessments will be carried out by the same researcher to minimize inter-rater variability, and all training sessions will be supervised to ensure protocol adherence.
Data will be collected and recorded systematically at both time points, and all procedures will follow established ATS/ERS guidelines for respiratory muscle testing and standard sports science assessment protocols.
- Conditions
- Inspiratory Muscle Training
- Being tested
- High-Intensity Inspiratory Muscle Training, Control Group
- Keywords
- inspiratory muscle training, tackle football, core endurance, balance, performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Inspiratory Muscle TrainingBehavioural
Participants in the IMT Group will perform an 8-week high-intensity inspiratory muscle training protocol in addition to their routine team-based strength and conditioning program. Training loads will be individualized based on each athlete's maximal inspiratory pressure (MIP) and set at approximately 80% of MIP. Loads will be reassessed every two weeks, and the resistance will be adjusted to maintain the prescribed intensity.
Control GroupBehavioural
Participants in the Control Group will continue their standard team-based strength, conditioning, and field training sessions throughout the 8-week study period. They will not receive inspiratory muscle training or any additional respiratory intervention.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Inspiratory Muscle Training Group | Experimental | Inspiratory muscle training Team strength and conditioning training Receives: Behavioral: High-Intensity Inspiratory Muscle Training |
| Control Group | Active comparator | Team strength and conditioning training Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Inspiratory Pressure test
Maximal inspiratory pressure (MIP) will be measured at the mouth using a handheld pressure manometer in accordance with ATS/ERS recommendations. Participants will perform at least three maximal inspiratory efforts from residual volume, and the highest reproducible value will be recorded in cmH₂O.
Measured: Baseline and after 8 weeks of training
Maximal Expiratory Pressure (MEP)
Maximal expiratory pressure (MEP) will be assessed with a handheld pressure manometer according to ATS/ERS standards. Participants will perform at least three maximal expiratory efforts from total lung capacity, and the highest reproducible value will be recorded in cmH₂O.
Measured: Baseline and after 8 weeks of training
Secondary outcomes (5)
Core muscle endurance
Core muscle endurance will be evaluated using the McGill core endurance tests (trunk flexor endurance, trunk extensor endurance, and right/left lateral plank endurance). During each test, participants will maintain the required test position as long as possible, and endurance time will be recorded in seconds.
Measured: Baseline and after 8 weeks of training
Balance Performance (Static and Dynamic)
Balance performance will be evaluated using a computerized balance analysis system. Standardized static and dynamic balance tasks will be performed, and stability indices/output parameters provided by the system will be recorded.
Measured: Baseline and after 8 weeks
Vertical Jump Height
Vertical jump performance will be assessed using a validated force platform or jump measurement device. Participants will perform three maximal countermovement jumps with hands on hips, and the highest reproducible jump height will be recorded in centimeters.
Measured: Baseline and after 8 weeks
Isometric Leg Strength
Isometric leg strength will be measured using an isometric dynamometer (e.g., Takei Back and Leg Dynamometer). Participants will perform three maximal isometric leg extension or leg-back pulling efforts following standardized testing instructions. The highest reproducible value (kg or Newtons) will be recorded.
Measured: Baseline and after 8 weeks
Yo-Yo Intermittent Recovery Test Level 1 Performance (Yo-Yo IR1)
The Yo-Yo Intermittent Recovery Test Level 1 will be administered following the standard protocol. Total distance completed (meters) before volitional exhaustion or failure to meet audio cues will be recorded.
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start20 Nov 2025
- Primary completion20 Jan 2026
- Study completion21 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inspiratory Muscle TrainingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Namik Kemal University
- Responsible party
- Sponsor
- Investigators
- Elif Develi, PhD., Principal investigator, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246655
- Sponsor's protocol ID
- YeditepeU 312
- Status last verified
- Jan 2026
- First submitted
- 17 Nov 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this study is a graduate thesis project involving a limited sample of athletes, and data cannot be publicly released to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Intensity Inspiratory Muscle Training on Respiratory Muscle Strength, Balance, and Core Endurance in American Football Players
- ClinicalTrials.gov ID
- NCT07246655
- Acronym / sponsor ID
- YeditepeU 312
- Conditions
- Inspiratory Muscle Training
- Keywords
- inspiratory muscle training, tackle football, core endurance, balance, performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Collaborators
- Namik Kemal University
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 24 Nov 2025 (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.
The aim of the randomized controlled study is to investigate the effects of high-intensity inspiratory muscle training on respiratory strength, balance, and core endurance in American Football (Tackle Football) athletes.
Detailed description
After completing baseline assessments, participants will be randomly assigned to either the High-Intensity Inspiratory Muscle Training group (IMT Group) or the Control Group (CG) using simple randomization procedures.
All athletes in both groups will continue their regular team-based strength and conditioning routines throughout the 8-week study period. Participants in the IMT Group will additionally perform a high-intensity inspiratory muscle training protocol three times per week, with training loads set at approximately 80% of each athlete's measured maximal inspiratory pressure (MIP). Training intensity will be reassessed bi-weekly and adjusted according to updated MIP values to ensure that the prescribed load is maintained throughout the intervention. The Control Group will not receive inspiratory muscle training and will perform only their routine training program.
All athletes will be evaluated at baseline and at the end of the 8-week intervention. Outcome measures will include respiratory muscle strength (MIP/MEP), dynamic and static balance performance, core muscle endurance (McGill core endurance tests), and sport-specific performance parameters relevant to American football. Assessments will be carried out by the same researcher to minimize inter-rater variability, and all training sessions will be supervised to ensure protocol adherence.
Data will be collected and recorded systematically at both time points, and all procedures will follow established ATS/ERS guidelines for respiratory muscle testing and standard sports science assessment protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Inspiratory Muscle Training Group | Experimental | Behavioral: High-Intensity Inspiratory Muscle TrainingInspiratory muscle training Team strength and conditioning training |
| Control Group | Active comparator | Behavioral: Control GroupTeam strength and conditioning training |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Self-identified male American football athletes
- Ages 18 to 35 years
- Actively participating in team-based training at the time of study enrollment
- Minimum 1 year of organized American football training experience
- Able to perform high-intensity inspiratory muscle training (IMT)
Key exclusion criteria (7 listed)
- Acute or chronic respiratory disease (e.g., uncontrolled asthma, COPD)
- History of major cardiovascular, neurological, or musculoskeletal disorders affecting performance
- Current rib, spine, abdominal, or core muscle injury
- Diagnosed pulmonary hypertension or unstable cardiac conditions
- Recent surgery (within the past 3 months)
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 |
|---|---|---|
| High-Intensity Inspiratory Muscle TrainingParticipants in the IMT Group will perform an 8-week high-intensity inspiratory muscle training protocol in addition to their routine team-based strength and conditioning program. Training loads will be individualized based on each athlete's maximal inspiratory pressure (MIP) and set at approximately 80% of MIP. Loads will be reassessed every two weeks, and the resistance will be adjusted to maintain the prescribed intensity. | Behavioural | High-Intensity Inspiratory Muscle Training Group |
| Control GroupParticipants in the Control Group will continue their standard team-based strength, conditioning, and field training sessions throughout the 8-week study period. They will not receive inspiratory muscle training or any additional respiratory intervention. | Behavioural | Control Group |
Primary outcome
Maximum Inspiratory Pressure test
Time frame: Baseline and after 8 weeks of training
Maximal inspiratory pressure (MIP) will be measured at the mouth using a handheld pressure manometer in accordance with ATS/ERS recommendations. Participants will perform at least three maximal inspiratory efforts from residual volume, and the highest reproducible value will be recorded in cmH₂O.
Maximal Expiratory Pressure (MEP)
Time frame: Baseline and after 8 weeks of training
Maximal expiratory pressure (MEP) will be assessed with a handheld pressure manometer according to ATS/ERS standards. Participants will perform at least three maximal expiratory efforts from total lung capacity, and the highest reproducible value will be recorded in cmH₂O.
5 secondary outcomes
Core muscle endurance
Time frame: Baseline and after 8 weeks of training
Balance Performance (Static and Dynamic)
Time frame: Baseline and after 8 weeks
Vertical Jump Height
Time frame: Baseline and after 8 weeks
Isometric Leg Strength
Time frame: Baseline and after 8 weeks
Yo-Yo Intermittent Recovery Test Level 1 Performance (Yo-Yo IR1)
Time frame: Baseline and after 8 weeks
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 22 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this study is a graduate thesis project involving a limited sample of athletes, and data cannot be publicly released to protect participant privacy.
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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.
Elif Develi, PhD. principal investigator
Yeditepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Inspiratory Muscle Training in people with Inspiratory Muscle Training, run by Yeditepe University 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 7 inclusion and 7 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 22 Jan 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?
Maximum Inspiratory Pressure test (time frame: Baseline and after 8 weeks of training). The study lists 2 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 22 Jan 2026.