NCT07319962

Brief Summary

American football has become an increasingly popular sport in Türkiye, and one of the key determinants of success in this discipline is the development of strong aerobic and anaerobic exercise capacities. Previous research has examined arterial stiffness in various athletic populations, including endurance athletes, wrestlers, badminton players, volleyball players, and soccer players. These studies highlight the importance of detailed cardiovascular and hemodynamic evaluation to identify potential risk groups and to better understand sport-specific physiological adaptations. In sports requiring prolonged physical effort, maximal oxygen uptake is a major determinant of performance, underscoring the need to assess this parameter in elite athletic populations. Although a limited number of studies have investigated aerobic and anaerobic exercise capacities in American football athletes, no research to date has evaluated arterial stiffness or intercostal muscle oxygenation in this group. The present study aims to investigate arterial stiffness, intercostal muscle oxygenation, aerobic and anaerobic exercise capacity, and upper-extremity endurance in elite American football players compared with sedentary individuals. A cross-sectional study design will be used. Elite male athletes from the Gazi University American Football Team who volunteer to participate will be included, and their results will be compared with age- and sex-matched sedentary individuals. A total of 15 elite male athletes and 15 sedentary participants aged 18-30 years will be enrolled. All participants will undergo standardized assessments of arterial stiffness, intercostal muscle oxygenation, aerobic and anaerobic capacity, and upper-extremity endurance. Normality of variables will be assessed using visual inspection and the Kolmogorov-Smirnov and Shapiro-Wilk tests. Descriptive statistics will be reported as means, standard deviations, and 95% confidence intervals for normally distributed variables, and medians with interquartile ranges (25th-75th percentiles) for non-normally distributed variables. Frequencies and percentages will be used for categorical data. Between-group comparisons will be conducted using the independent samples t-test for normally distributed variables and the Mann-Whitney U test for non-normally distributed variables. Categorical variables will be analyzed using the chi-square test. A p-value of \<0.05 will be considered statistically significant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 8, 2025

Last Update Submit

December 20, 2025

Conditions

Keywords

American footballarterial stiffnessmuscle oxygenationaerobic capacityanaerobic capacity

Outcome Measures

Primary Outcomes (11)

  • Arterial stiffness

    Arterial stiffness was assessed noninvasively using the SphygmoCor XCEL® system (AtCor Medical, Sydney, Australia), a device with established validity and reliability for evaluating central hemodynamic parameters. The device provided measures of aortic systolic blood pressure (SBP), aortic pulse pressure (APP), augmentation pressure (AP), augmentation index (AIx), heart rate-corrected augmentation index (AIx@75), aortic diastolic pressure (DBP), mean arterial pressure (MAP), heart rate (HR), and ejection duration (ED).

    First Day

  • Aortic systolic blood pressure (SBP)

    Aortic systolic blood pressure (SBP) was assessed noninvasively using the SphygmoCor XCEL® system (AtCor Medical, Sydney, Australia), a device with established validity and reliability for evaluating central hemodynamic parameters.

    First Day

  • Aortic pulse pressure (APP)

    Aortic pulse pressure (APP)was assessed noninvasively using the SphygmoCor XCEL® system (AtCor Medical, Sydney, Australia), a device with established validity and reliability for evaluating central hemodynamic parameters.

    First Day

  • Augmentation pressure (AP)

    Augmentation pressure (AP) was assessed noninvasively using the SphygmoCor XCEL® system (AtCor Medical, Sydney, Australia), a device with established validity and reliability for evaluating central hemodynamic parameters.

    First Day

  • Heart rate-corrected augmentation index (AIx@75)

    Heart rate-corrected augmentation index (AIx@75) was assessed noninvasively using the SphygmoCor XCEL® system (AtCor Medical, Sydney, Australia), a device with established validity and reliability for evaluating central hemodynamic parameters.

    First Day

  • Aortic diastolic pressure (DBP)

    Aortic diastolic pressure (DBP) was assessed noninvasively using the SphygmoCor XCEL® system (AtCor Medical, Sydney, Australia), a device with established validity and reliability for evaluating central hemodynamic parameters.

    First Day

  • Mean arterial pressure (MAP)

    Arterial stiffness was assessed noninvasively using the SphygmoCor XCEL® system (AtCor Medical, Sydney, Australia), a device with established validity and reliability for evaluating central hemodynamic parameters.

    First Day

  • Heart rate (HR)

    Heart rate (HR) was assessed noninvasively using the SphygmoCor XCEL® system (AtCor Medical, Sydney, Australia), a device with established validity and reliability for evaluating central hemodynamic parameters.

    First Day

  • Ejection duration (ED)

    Ejection duration (ED) was assessed noninvasively using the SphygmoCor XCEL® system (AtCor Medical, Sydney, Australia), a device with established validity and reliability for evaluating central hemodynamic parameters.

    First Day

  • Muscle oxygenation

    Muscle oxygenation was assessed using the Moxy® Monitor (Fortiori Design LLC, Minnesota, USA), a small, lightweight, and wireless near-infrared spectroscopy (NIRS) device that measures local muscle oxygen saturation (SmO₂) and total hemoglobin (THb) in the capillary bed of the underlying muscle tissue.

    First Day

  • Aerobic exercise capacity

    Maximal exercise capacity was evaluated using the ISWT, a standardized, externally paced, symptom-limited field test that progressively increases walking speed at one-minute intervals.

    First day

Secondary Outcomes (2)

  • Anaerobic exercise capacity

    First day

  • Anaerobic power

    First day

Study Arms (2)

Elite male American football players

Demographic characteristics were recorded. Inclusion criteria for the elite American football group were being a male athlete aged 18-30 years and volunteering to participate. Exclusion criteria included having any acute infection, orthopedic, neurological, or sensory problems (hearing, vision, or cooperation difficulties) that could interfere with measurements, a history of smoking, alcohol consumption, or COVID-19 infection, and use of medications or antioxidant supplements. Aerobic exercise capacity was evaluated using the Incremental Shuttle Walking Test (ISWT), anaerobic exercise capacity with the Vertical Jump Test, arterial stiffness using the SphygmoCor® XCEL Pulse Wave Analysis (PWA) Arteriograph, and intercostal muscle oxygenation by the Moxy® Muscle Oxygen Monitor.

Health Controls

Demographic characteristics were recorded. The sedentary group (sedentary individuals were defined as those engaging in less than 150 minutes per week of moderate-intensity physical activity or its equivalent, according to WHO guidelines, inclusion criteria were being a male aged 18-30 years and volunteering to participate, while exclusion criteria included any acute, orthopedic, neurological, or sensory condition that might interfere with the assessments, as well as having a regular exercise habit. Aerobic exercise capacity was evaluated using Incremental Shuttle Walking Test (ISWT), anaerobic exercise capacity with the Vertical Jump Test, arterial stiffness using the SphygmoCor® XCEL Pulse Wave Analysis (PWA) Arteriograph, and intercostal muscle oxygenation by the Moxy® Muscle Oxygen Monitor.

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Thirty participants, including 15 American football players and 15 healthy controls, were evaluated.

You may qualify if:

  • Being a male athlete aged 18-30 years
  • Volunteering to participate

You may not qualify if:

  • Having any acute infection, orthopedic, neurological, or sensory problems (hearing, vision, or cooperation difficulties) that could interfere with measurements
  • A history of smoking
  • A history of alcohol consumption
  • A history of COVID-19 infection
  • Use of medications or antioxidant supplements
  • Being a male aged 18-30 years
  • Volunteering to participate
  • Included any acute, orthopedic, neurological, or sensory condition that might interfere with the assessments
  • Having a regular exercise habit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Health Sciences Department of Cardiopulmonary Physiotherapy and Rehabilitation, Ankara, Çankaya 06490

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location

Related Publications (7)

  • Ross A, Leveritt M. Long-term metabolic and skeletal muscle adaptations to short-sprint training: implications for sprint training and tapering. Sports Med. 2001;31(15):1063-82. doi: 10.2165/00007256-200131150-00003.

  • Mayorga-Vega D, Aguilar-Soto P, Viciana J. Criterion-Related Validity of the 20-M Shuttle Run Test for Estimating Cardiorespiratory Fitness: A Meta-Analysis. J Sports Sci Med. 2015 Aug 11;14(3):536-47. eCollection 2015 Sep.

  • Allen TW, Vogel RA, Lincoln AE, Dunn RE, Tucker AM. Body size, body composition, and cardiovascular disease risk factors in NFL players. Phys Sportsmed. 2010 Apr;38(1):21-7. doi: 10.3810/psm.2010.04.1758.

  • Bangsbo J, Mohr M, Krustrup P. Physical and metabolic demands of training and match-play in the elite football player. J Sports Sci. 2006 Jul;24(7):665-74. doi: 10.1080/02640410500482529.

  • Perrey S, Quaresima V, Ferrari M. Muscle Oximetry in Sports Science: An Updated Systematic Review. Sports Med. 2024 Apr;54(4):975-996. doi: 10.1007/s40279-023-01987-x. Epub 2024 Feb 12.

  • Ashor AW, Lara J, Siervo M, Celis-Morales C, Mathers JC. Effects of exercise modalities on arterial stiffness and wave reflection: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2014 Oct 15;9(10):e110034. doi: 10.1371/journal.pone.0110034. eCollection 2014.

  • Kresnajati S, Lin YY, Mundel T, Bernard JR, Lin HF, Liao YH. Changes in Arterial Stiffness in Response to Various Types of Exercise Modalities: A Narrative Review on Physiological and Endothelial Senescence Perspectives. Cells. 2022 Nov 9;11(22):3544. doi: 10.3390/cells11223544.

Study Officials

  • Betül Yoleri, MSc

    Gazi University

    STUDY CHAIR
  • Meral Boşnak Güçlü, Prof

    Gazi University

    STUDY DIRECTOR
  • Neslişah Tunçay, Pt

    Gazi University

    PRINCIPAL INVESTIGATOR
  • Aleyna Gökdeniz, Pt

    Gazi University

    PRINCIPAL INVESTIGATOR
  • Bünyamin Ertuş, Pt

    Gazi University

    PRINCIPAL INVESTIGATOR
  • Esin Yağmur Kart, Pt

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

December 8, 2025

First Posted

January 6, 2026

Study Start

June 1, 2024

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

January 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations