Respiratory Muscle Function and Football PerformanceNCT07907510
Acute Effects of Breathing Resistance During Exercise in Football Players
A study testing Breathing-Resistance Exercise Mask and No-Mask Exercise in people with Respiratory Muscle Function and Football Performance, run by Karabuk University.
Trial summary
This randomized crossover study will examine the immediate effects of breathing resistance during exercise in 35 active football players aged 18-30 years. Each participant will perform the same football-related field tests under two conditions: wearing an exercise mask that adds mechanical resistance to breathing, and… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Muscle Function and Football Performance
- What is being tested?
- Breathing-Resistance Exercise Mask and No-Mask Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-30 years.
- Actively playing football and undertaking regular football training during the preceding six months.
- Regular participation in team and/or individual football training.
- Physically able to perform repeated-sprint and change-of-direction tests safely and complete testing with a breathing-resistance exercise mask.
- Able to understand and follow study assessment and exercise instructions.
- Voluntary participation and written informed consent.
Who cannot join
- Acute cardiopulmonary disease.
- Uncontrolled chronic disease or a chronic condition posing a risk during intense exercise.
- Serious lower-limb injury affecting football performance or testing within the preceding three months.
- Lower-limb surgery within the preceding three months.
- Musculoskeletal impairment preventing safe sprint or change-of-direction testing.
- Medical contraindication to intense exercise.
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- Stopping and Analysis Criteria:
- Testing will stop for chest pain, marked dizziness, presyncope, unusual breathlessness, or any finding judged unsafe by the researcher.
- Inability to complete either session or missing measurements that prevent valid paired assessment will preclude the affected paired analysis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Exercise-Induced Breathing Resistance on Respiratory Muscle Function, Physiological Responses, and Football-Specific Physical Performance in Football Players
This randomized crossover study will examine the immediate effects of breathing resistance during exercise in 35 active football players aged 18-30 years. Each participant will perform the same football-related field tests under two conditions: wearing an exercise mask that adds mechanical resistance to breathing, and without the mask. The order will be randomized, with at least 72 hours between sessions. Respiratory muscle strength will be assessed before and after exercise using maximal inspiratory and expiratory mouth pressures. Heart rate, oxygen saturation, perceived exertion, breathlessness, repeated-sprint performance, and change-of-direction performance will be compared between conditions. The mask is considered a breathing-resistance device, not a method of producing genuine altitude exposure or hypoxia.
Read the detailed description
Prospective randomized-sequence, two-condition crossover study involving 35 active football players aged 18-30 years with regular football training over the preceding six months. The target allows for loss or incomplete data, with at least 32 completers sought based on a paired comparison with two-sided alpha 0.05, power 0.90, and standardized effect size 0.60.
Participants will provide written informed consent. Age, height, weight, dominant side, football experience, weekly training duration, and playing position will be recorded. Standardized preparation and familiarization will precede testing. Each participant completes a respiratory-resistance exercise-mask condition and a no-mask control condition. Condition order is computer randomized, with at least 72 hours between sessions. Participants will avoid strenuous exercise before test days and maintain comparable sleep and nutritional routines. All field testing will use the same surface, comparable environmental conditions, and standardized warm-up.
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured before and after exercise using a calibrated mouth-pressure device and repeated acceptable and reproducible maneuvers. These are noninvasive measures of respiratory muscle function.
Heart rate and peripheral oxygen saturation (SpO2) will be monitored at standardized time points. Motion artifact, peripheral perfusion, sensor placement, and signal quality will be considered when recording pulse oximetry. Perceived exertion and breathlessness will be rated separately with the Borg category-ratio scale.
Repeated-sprint testing consists of five 30-meter linear sprints with 30-second active recovery intervals. Electronic timing records each sprint, with best, total/mean time, and performance decrement derived. The 505 change-of-direction test involves crossing the timing line, running 5 meters to a turning line, making a 180-degree turn, and returning through the timing line. Right and left turns will be standardized and electronically timed.
Testing will stop for chest pain, marked dizziness, presyncope, unusual breathlessness, or any finding judged unsafe by the researcher. No blood collection, invasive procedure, or therapeutic intervention is planned. Assessments will be conducted by the research team in an appropriate sports-field/laboratory setting.
Paired analyses will compare conditions. Repeated-measures analyses or linear mixed models will assess condition, time, and condition-by-time effects for pre/post variables including MIP and MEP. Heart rate, SpO2, perceived exertion, breathlessness, repeated-sprint performance and decrement, and 505 performance will be compared between conditions. Relationships between acute respiratory pressure changes and performance will be explored with Pearson or Spearman correlations. Sequence and period effects will be included where appropriate, and effect sizes and 95% confidence intervals will accompany inferential results. Two-sided p<0.05 will be used.
The mask condition uses the Elevation Training Mask 2.0 (Training Mask, Inc., USA), with the original manufacturer-labeled 9,000 ft valve configuration throughout field testing. This label identifies airflow resistance, not actual altitude or verified hypoxia. The same configuration is used across participants, with fit adjusted individually. The selected setting is based on published acute crossover research (Ozdemir et al., 2026; doi:10.1186/s13102-026-01892-6). Total repeated-sprint time is the primary outcome.
- Being tested
- Breathing-Resistance Exercise Mask, No-Mask Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing-Resistance Exercise MaskDevice
Elevation Training Mask 2.0 (Training Mask, Inc., USA), using the original manufacturer-labeled 9,000 ft resistance configuration during standardized repeated-sprint and 505 change-of-direction testing. Fit is adjusted individually; the same valve configuration is used for all participants. The label represents mechanical airflow resistance and does not establish hypoxia or altitude equivalence.
No-Mask ExerciseOther
The same standardized warm-up, five 30-meter sprints with 30-second active recovery, and 505 change-of-direction testing are performed without a breathing-resistance mask. Sessions are separated by at least 72 hours and use comparable testing conditions.
| Study group | Role | What they receive |
|---|---|---|
| Mask Then No-Mask Sequence | Experimental | Participants complete standardized football field tests wearing the Elevation Training Mask 2.0 at the manufacturer-labeled 9,000 ft airflow-resistance setting, then repeat the tests without a mask at least 72 hours later. The setting denotes mechanical resistance, not actual altitude or hypoxia. Receives: Device: Breathing-Resistance Exercise Mask; Other: No-Mask Exercise |
| No-Mask Then Mask Sequence | Experimental | Participants complete standardized football field tests without a mask, then repeat the tests wearing the Elevation Training Mask 2.0 at the manufacturer-labeled 9,000 ft airflow-resistance setting at least 72 hours later. Receives: Device: Breathing-Resistance Exercise Mask; Other: No-Mask Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Repeated-Sprint Time
Sum of electronically timed completion times, in seconds, for five 30-meter linear sprints separated by 30-second active recovery. Lower values indicate better performance. Mask and no-mask conditions are compared within participants.
Measured: During repeated-sprint testing in each of two sessions separated by at least 72 hours.
Secondary outcomes (8)
Best and Mean Sprint Time
Best (minimum) and arithmetic mean electronically timed 30-meter sprint completion times, reported separately in seconds across five sprints. Lower values indicate better performance.
Measured: During repeated-sprint testing in each session; sessions at least 72 hours apart.
Repeated-Sprint Performance Decrement
Percentage decrement calculated as 100 x [(total sprint time / (best sprint time x 5)) - 1]. Higher percentages indicate greater performance decrement.
Measured: During repeated-sprint testing in each session; sessions at least 72 hours apart.
Maximal Inspiratory Pressure
Maximal inspiratory mouth pressure (MIP), in cmH2O, obtained with a calibrated pressure device using acceptable, reproducible maneuvers. Pre-to-post exercise changes are compared between conditions.
Measured: Before and immediately after exercise in each of two sessions at least 72 hours apart.
Maximal Expiratory Pressure
Maximal expiratory mouth pressure (MEP), in cmH2O, obtained with a calibrated pressure device using acceptable, reproducible maneuvers. Pre-to-post exercise changes are compared between conditions.
Measured: Before and immediately after exercise in each of two sessions at least 72 hours apart.
505 Change-of-Direction Time
Electronically timed 505 test completion time, in seconds, with right and left turning directions recorded separately. Lower values indicate better performance.
Measured: During 505 testing in each session; sessions at least 72 hours apart.
Heart Rate
Heart rate in beats per minute recorded before exercise, during testing where signal quality permits, and immediately after exercise. Corresponding assessment points are compared between conditions.
Measured: Before, during and immediately after exercise in each session; sessions at least 72 hours apart.
Peripheral Oxygen Saturation
Peripheral oxygen saturation (SpO2), expressed as a percentage, measured by pulse oximetry. Valid signals at corresponding assessment points are compared between conditions.
Measured: Before, during and immediately after exercise in each session; sessions at least 72 hours apart.
Perceived Exertion and Breathlessness
Perceived exertion and breathlessness are rated separately using the Borg category-ratio 0-10 scale; higher scores indicate greater exertion or breathlessness.
Measured: Immediately after each field test in each session; sessions at least 72 hours apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Muscle Function and Football PerformanceStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant completes mask and no-mask conditions in a computer-randomized sequence (mask then no-mask or no-mask then mask), with at least 72 hours between sessions. The same repeated-sprint and change-of-direction tests are performed in both conditions.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece ACAR, Karabuk University
- Investigators
- Ece Acar, PhD, PT, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907510
- Sponsor's protocol ID
- KBU-FOOTBALL-RESP-2026
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise-Induced Breathing Resistance on Respiratory Muscle Function, Physiological Responses, and Football-Specific Physical Performance in Football Players
- ClinicalTrials.gov ID
- NCT07907510
- Acronym / sponsor ID
- KBU-FOOTBALL-RESP-2026
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Oct 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 crossover study will examine the immediate effects of breathing resistance during exercise in 35 active football players aged 18-30 years. Each participant will perform the same football-related field tests under two conditions: wearing an exercise mask that adds mechanical resistance to breathing, and without the mask. The order will be randomized, with at least 72 hours between sessions. Respiratory muscle strength will be assessed before and after exercise using maximal inspiratory and expiratory mouth pressures. Heart rate, oxygen saturation, perceived exertion, breathlessness, repeated-sprint performance, and change-of-direction performance will be compared between conditions. The mask is considered a breathing-resistance device, not a method of producing genuine altitude exposure or hypoxia.
Detailed description
Prospective randomized-sequence, two-condition crossover study involving 35 active football players aged 18-30 years with regular football training over the preceding six months. The target allows for loss or incomplete data, with at least 32 completers sought based on a paired comparison with two-sided alpha 0.05, power 0.90, and standardized effect size 0.60.
Participants will provide written informed consent. Age, height, weight, dominant side, football experience, weekly training duration, and playing position will be recorded. Standardized preparation and familiarization will precede testing. Each participant completes a respiratory-resistance exercise-mask condition and a no-mask control condition. Condition order is computer randomized, with at least 72 hours between sessions. Participants will avoid strenuous exercise before test days and maintain comparable sleep and nutritional routines. All field testing will use the same surface, comparable environmental conditions, and standardized warm-up.
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured before and after exercise using a calibrated mouth-pressure device and repeated acceptable and reproducible maneuvers. These are noninvasive measures of respiratory muscle function.
Heart rate and peripheral oxygen saturation (SpO2) will be monitored at standardized time points. Motion artifact, peripheral perfusion, sensor placement, and signal quality will be considered when recording pulse oximetry. Perceived exertion and breathlessness will be rated separately with the Borg category-ratio scale.
Repeated-sprint testing consists of five 30-meter linear sprints with 30-second active recovery intervals. Electronic timing records each sprint, with best, total/mean time, and performance decrement derived. The 505 change-of-direction test involves crossing the timing line, running 5 meters to a turning line, making a 180-degree turn, and returning through the timing line. Right and left turns will be standardized and electronically timed.
Testing will stop for chest pain, marked dizziness, presyncope, unusual breathlessness, or any finding judged unsafe by the researcher. No blood collection, invasive procedure, or therapeutic intervention is planned. Assessments will be conducted by the research team in an appropriate sports-field/laboratory setting.
Paired analyses will compare conditions. Repeated-measures analyses or linear mixed models will assess condition, time, and condition-by-time effects for pre/post variables including MIP and MEP. Heart rate, SpO2, perceived exertion, breathlessness, repeated-sprint performance and decrement, and 505 performance will be compared between conditions. Relationships between acute respiratory pressure changes and performance will be explored with Pearson or Spearman correlations. Sequence and period effects will be included where appropriate, and effect sizes and 95% confidence intervals will accompany inferential results. Two-sided p<0.05 will be used.
The mask condition uses the Elevation Training Mask 2.0 (Training Mask, Inc., USA), with the original manufacturer-labeled 9,000 ft valve configuration throughout field testing. This label identifies airflow resistance, not actual altitude or verified hypoxia. The same configuration is used across participants, with fit adjusted individually. The selected setting is based on published acute crossover research (Ozdemir et al., 2026; doi:10.1186/s13102-026-01892-6). Total repeated-sprint time is the primary outcome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant completes mask and no-mask conditions in a computer-randomized sequence (mask then no-mask or no-mask then mask), with at least 72 hours between sessions. The same repeated-sprint and change-of-direction tests are performed in both conditions.
| Arm | Type | Receives |
|---|---|---|
| Mask Then No-Mask Sequence | Experimental | Device: Breathing-Resistance Exercise Mask, Other: No-Mask ExerciseParticipants complete standardized football field tests wearing the Elevation Training Mask 2.0 at the manufacturer-labeled 9,000 ft airflow-resistance setting, then repeat the tests without a mask at least 72 hours later. The setting denotes mechanical resistance, not actual altitude or hypoxia. |
| No-Mask Then Mask Sequence | Experimental | Device: Breathing-Resistance Exercise Mask, Other: No-Mask ExerciseParticipants complete standardized football field tests without a mask, then repeat the tests wearing the Elevation Training Mask 2.0 at the manufacturer-labeled 9,000 ft airflow-resistance setting at least 72 hours later. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 18-30 years.
- Actively playing football and undertaking regular football training during the preceding six months.
- Regular participation in team and/or individual football training.
- Physically able to perform repeated-sprint and change-of-direction tests safely and complete testing with a breathing-resistance exercise mask.
- Able to understand and follow study assessment and exercise instructions.
Key exclusion criteria (9 listed)
- Acute cardiopulmonary disease.
- Uncontrolled chronic disease or a chronic condition posing a risk during intense exercise.
- Serious lower-limb injury affecting football performance or testing within the preceding three months.
- Lower-limb surgery within the preceding three months.
- Musculoskeletal impairment preventing safe sprint or change-of-direction testing.
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 |
|---|---|---|
| Breathing-Resistance Exercise MaskElevation Training Mask 2.0 (Training Mask, Inc., USA), using the original manufacturer-labeled 9,000 ft resistance configuration during standardized repeated-sprint and 505 change-of-direction testing. Fit is adjusted individually; the same valve configuration is used for all participants. The label represents mechanical airflow resistance and does not establish hypoxia or altitude equivalence. | Device | Mask Then No-Mask Sequence, No-Mask Then Mask Sequence |
| No-Mask ExerciseThe same standardized warm-up, five 30-meter sprints with 30-second active recovery, and 505 change-of-direction testing are performed without a breathing-resistance mask. Sessions are separated by at least 72 hours and use comparable testing conditions. | Other | Mask Then No-Mask Sequence, No-Mask Then Mask Sequence |
Primary outcome
Total Repeated-Sprint Time
Time frame: During repeated-sprint testing in each of two sessions separated by at least 72 hours.
Sum of electronically timed completion times, in seconds, for five 30-meter linear sprints separated by 30-second active recovery. Lower values indicate better performance. Mask and no-mask conditions are compared within participants.
8 secondary outcomes
Best and Mean Sprint Time
Time frame: During repeated-sprint testing in each session; sessions at least 72 hours apart.
Repeated-Sprint Performance Decrement
Time frame: During repeated-sprint testing in each session; sessions at least 72 hours apart.
Maximal Inspiratory Pressure
Time frame: Before and immediately after exercise in each of two sessions at least 72 hours apart.
Maximal Expiratory Pressure
Time frame: Before and immediately after exercise in each of two sessions at least 72 hours apart.
505 Change-of-Direction Time
Time frame: During 505 testing in each session; sessions at least 72 hours apart.
Heart Rate
Time frame: Before, during and immediately after exercise in each session; sessions at least 72 hours apart.
Peripheral Oxygen Saturation
Time frame: Before, during and immediately after exercise in each session; sessions at least 72 hours apart.
Perceived Exertion and Breathlessness
Time frame: Immediately after each field test in each session; sessions at least 72 hours apart.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Ece Acar, PhD, PT principal investigator
Karabuk University
Questions about this trial
What is this clinical trial studying?
A study testing Breathing-Resistance Exercise Mask and No-Mask Exercise in people with Respiratory Muscle Function and Football Performance, run by Karabuk University.
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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ece Acar, PhD, PT (+905457925035, eceacar@karabuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Repeated-Sprint Time (time frame: During repeated-sprint testing in each of two sessions separated by at least 72 hours.). 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 30 Oct 2026.