- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07246655
Inspiratory Muscle Training in American Football Players
Effects of High-Intensity Inspiratory Muscle Training on Respiratory Muscle Strength, Balance, and Core Endurance in American Football Players
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Süleymanpaşa
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Tekirdağ, Süleymanpaşa, Turkey (Türkiye), 59100
- Tekirdağ Namık Kemal Univercity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High-Intensity Inspiratory Muscle Training Group
Inspiratory muscle training Team strength and conditioning training
|
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.
|
|
Active Comparator: Control Group
Team strength and conditioning training
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline and after 8 weeks of training
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Maximal Expiratory Pressure (MEP)
Time Frame: Baseline and after 8 weeks of training
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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.
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Baseline and after 8 weeks of training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Core muscle endurance
Time Frame: Baseline and after 8 weeks of training
|
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.
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Baseline and after 8 weeks of training
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Balance Performance (Static and Dynamic)
Time Frame: Baseline and after 8 weeks
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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.
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Baseline and after 8 weeks
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Vertical Jump Height
Time Frame: Baseline and after 8 weeks
|
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.
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Baseline and after 8 weeks
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Isometric Leg Strength
Time Frame: Baseline and after 8 weeks
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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.
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Baseline and after 8 weeks
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Yo-Yo Intermittent Recovery Test Level 1 Performance (Yo-Yo IR1)
Time Frame: Baseline and after 8 weeks
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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.
|
Baseline and after 8 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elif Develi, PhD., Yeditepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YeditepeU 312
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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