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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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.
Show all 9Show fewer
  • 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.

Ece Acar, PhD, PT contact

+905457925035

eceacar@karabuk.edu.tr

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 groups in NCT07907510
Study groupRoleWhat they receive
Mask Then No-Mask SequenceExperimentalParticipants 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 SequenceExperimentalParticipants 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.

  1. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  1. First posted30 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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)
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

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.

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