NCT07092969

Brief Summary

This study aims to compare the effects of aerobic and anaerobic exercise on hormonal, immunological, and metabolic biomarkers in young individuals using blood and saliva samples. It will also assess participants' physical activity levels, depression levels, and general lifestyle habits to explore their relationship with biomarker profiles. Biomarkers such as testosterone, progesterone, cortisol, IgA, alpha-amylase, insulin, lactate, and various inflammatory cytokines will be measured using ELISA. The study seeks to evaluate the physiological and psychosocial effects of different types of exercise in a holistic manner.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Sep 2025

Status
not yet recruiting

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

Study Progress64%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

July 21, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Expected
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 21, 2025

Last Update Submit

July 28, 2025

Conditions

Keywords

Exercise physiologyAerobic and anaerobic exercisHormonal and immunological responsesPhysical activity

Outcome Measures

Primary Outcomes (7)

  • Change in Salivary Testosterone Level

    Measurement of testosterone concentration in saliva pre- and post-exercise.

    Time Frame: Baseline and immediately post-exercise Unit of Measure: pg/mL

  • Change in Salivary Cortisol Level

    Measurement of cortisol concentration in saliva before and after aerobic and anaerobic exercise protocols.

    Time Frame: Baseline (pre-exercise) and immediately post-exercise (within 1 hour) Unit of Measure: ng/mL

  • Change in Salivary Progesterone Level

    Salivary progesterone levels before and after exercise.

    Time Frame: Baseline and immediately post-exercise Unit of Measure: pg/mL

  • Change in Salivary Alpha-Amylase Activity

    Enzymatic activity of salivary alpha-amylase as a stress marker.

    Time Frame: Baseline and post-exercise Unit of Measure: U/mL

  • Change in Blood Lactate Level

    Lactate concentration in blood samples collected before and after exercise.

    Time Frame: Baseline and post-exercise Unit of Measure: µIU/mL

  • Change in Serum Cytokine Levels (e.g., IL-6, TNF-α)

    Evaluation of pro- and anti-inflammatory cytokines in serum.

    Time Frame: Baseline and immediately post-exercise Unit of Measure: pg/mL

  • Change in Salivary Immunoglobulin A (IgA)

    Level of IgA in saliva as a marker of mucosal immune response.

    Time Frame: Baseline and post-exercise Unit of Measure: µg/mL

Secondary Outcomes (2)

  • Change in Depression Score (Beck Depression Inventory-II)

    Time Frame: Baseline (pre-intervention) and post-intervention (within 1 hour after final session) Unit of Measure: Score (range: 0-63) Method of Measurement: Self-reported questionnaire

  • Change in Physical Activity Level (IPAQ-Short Form)

    Time Frame: Baseline and post-intervention Unit of Measure: MET-minutes/week

Study Arms (3)

Group I - Control Group:

NO INTERVENTION

This group will not receive any training intervention. Participants will only undergo the Bruce Protocol and Wingate tests to serve as a baseline reference for physiological responses, allowing comparison with the other two groups.

Group II - Treadmill Exercise (Bruce Protocol):

EXPERIMENTAL

Participants will perform the Bruce Protocol on a treadmill, which involves progressive stages of increasing speed and incline to challenge cardiovascular endurance. At each stage, heart rate, blood pressure, and fatigue level will be recorded. The session will end with a cool-down phase.

Device: Treadmill Exercise

Group III - Bicycle Exercise (Wingate Anaerobic Test):

EXPERIMENTAL

This group will perform the Wingate Anaerobic Test using a stationary exercise bike. Following a warm-up, participants will cycle at maximum effort for 30 seconds to assess anaerobic performance. Data collected will include pedaling speed, power output, heart rate, and oxygen saturation.

Device: Bicycle Exercise

Interventions

Participants in this group will perform an aerobic exercise using the Bruce Protocol on a treadmill. The test involves walking or running with gradually increasing speed and incline in predefined stages to assess cardiovascular endurance. Heart rate, blood pressure, and fatigue levels will be recorded at each stage. The session will conclude with a low-intensity cool-down phase.

Group II - Treadmill Exercise (Bruce Protocol):

The Wingate Anaerobic Test will be conducted using an ergometer bike. After a standardized warm-up, participants will pedal all-out for 30 seconds against a preset resistance, aiming to evaluate their anaerobic performance. Physiological parameters including power output, heart rate, and oxygen saturation will be monitored throughout the test.

Group III - Bicycle Exercise (Wingate Anaerobic Test):

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being a university student,
  • Being between the ages of 18 and 25.

You may not qualify if:

  • Having orthopedic problems that prevent exercise,
  • Having cognitive or mental health problems that prevent participation in exercise,
  • Having chronic systemic diseases such as cardiac, pulmonary, or nephrological.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Guest NS, VanDusseldorp TA, Nelson MT, Grgic J, Schoenfeld BJ, Jenkins NDM, Arent SM, Antonio J, Stout JR, Trexler ET, Smith-Ryan AE, Goldstein ER, Kalman DS, Campbell BI. International society of sports nutrition position stand: caffeine and exercise performance. J Int Soc Sports Nutr. 2021 Jan 2;18(1):1. doi: 10.1186/s12970-020-00383-4.

    PMID: 33388079BACKGROUND
  • Pedersen BK, Hoffman-Goetz L. Exercise and the immune system: regulation, integration, and adaptation. Physiol Rev. 2000 Jul;80(3):1055-81. doi: 10.1152/physrev.2000.80.3.1055.

    PMID: 10893431BACKGROUND
  • Gleeson M. Immune function in sport and exercise. J Appl Physiol (1985). 2007 Aug;103(2):693-9. doi: 10.1152/japplphysiol.00008.2007. Epub 2007 Feb 15.

    PMID: 17303714BACKGROUND
  • Mikkelsen K, Stojanovska L, Polenakovic M, Bosevski M, Apostolopoulos V. Exercise and mental health. Maturitas. 2017 Dec;106:48-56. doi: 10.1016/j.maturitas.2017.09.003. Epub 2017 Sep 7.

    PMID: 29150166BACKGROUND
  • Schuch FB, Vancampfort D, Firth J, Rosenbaum S, Ward PB, Silva ES, Hallgren M, Ponce De Leon A, Dunn AL, Deslandes AC, Fleck MP, Carvalho AF, Stubbs B. Physical Activity and Incident Depression: A Meta-Analysis of Prospective Cohort Studies. Am J Psychiatry. 2018 Jul 1;175(7):631-648. doi: 10.1176/appi.ajp.2018.17111194. Epub 2018 Apr 25.

    PMID: 29690792BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Abdurrahim Yıldız, Doc.Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study will be conducted in 2025 with 90 voluntary university students from the Department of Physiotherapy and Rehabilitation at Sakarya University of Applied Sciences. Participants will be aged 18-25 and free of chronic illnesses. Inclusion criteria are being a university student and within the specified age range. Exclusion criteria include orthopedic, cognitive, mental health problems, or chronic systemic diseases. Eligible students will be informed about the study's purpose, duration, potential risks, and methods, and will sign informed consent. Participants will be randomly divided into three equal groups, each receiving a different intervention, allowing comparison of physiological responses across groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doç.Dr

Study Record Dates

First Submitted

July 21, 2025

First Posted

July 30, 2025

Study Start

September 15, 2025

Primary Completion

March 15, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share