NCT07246655

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

November 20, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

November 17, 2025

Last Update Submit

January 21, 2026

Conditions

Keywords

inspiratory muscle trainingtackle footballcore endurancebalanceperformance

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and after 8 weeks of training

Secondary Outcomes (5)

  • Core muscle endurance

    Baseline and after 8 weeks of training

  • Balance Performance (Static and Dynamic)

    Baseline and after 8 weeks

  • Vertical Jump Height

    Baseline and after 8 weeks

  • Isometric Leg Strength

    Baseline and after 8 weeks

  • Yo-Yo Intermittent Recovery Test Level 1 Performance (Yo-Yo IR1)

    Baseline and after 8 weeks

Study Arms (2)

High-Intensity Inspiratory Muscle Training Group

EXPERIMENTAL

Inspiratory muscle training Team strength and conditioning training

Behavioral: High-Intensity Inspiratory Muscle Training

Control Group

ACTIVE COMPARATOR

Team strength and conditioning training

Behavioral: Control Group

Interventions

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.

High-Intensity Inspiratory Muscle Training Group
Control GroupBEHAVIORAL

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.

Control Group

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must be self-identified male American football athletes actively participating in team training.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tekirdağ Namık Kemal Univercity

Tekirdağ, Süleymanpaşa, 59100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Elif Develi, PhD.

    Yeditepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 24, 2025

Study Start

November 20, 2025

Primary Completion

January 20, 2026

Study Completion

January 21, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations