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Activity, MotorBiomarkersNCT07092969

Comparison of the Effects of Aerobic-Anaerobic Exercises on Hormonal and Immune Biomarkers

A study testing Treadmill Exercise and Bicycle Exercise in people with Activity, Motor and Biomarkers, run by Sakarya Applied Sciences 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 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. Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Activity, Motor, Biomarkers, Exercise
What is being tested?
Treadmill Exercise and Bicycle Exercise
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
15 Sep 2025to 15 Sep 2026
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 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Abdurrahim Yıldız, Doc.Dr. contact

+90 507 751 63 63

abdurrahimyildiz@subu.edu.tr

About this study

Official title: Comparison of the Effects of Aerobic and Anaerobic Exercises on Hormonal and Immune Biomarkers Measured by Blood and Saliva in Young Individuals

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.

Read the detailed description

Exercise is a complex stimulus that induces multifaceted effects on an individual's physiological and psychological systems. Aerobic and anaerobic types of exercise differ in terms of their energy production pathways and metabolic responses in the body. Aerobic exercises are long-duration, oxygen-dependent activities, while anaerobic exercises are short-duration, high-intensity activities that activate oxygen-independent energy systems.

These types of exercise cause various hormonal, immunological, and metabolic changes in the body. After exercise, significant changes are observed in biomarkers such as stress hormones (cortisol, progesterone), anabolic hormones (testosterone), immune system markers (IgA, TNF-α, IL-6, IL-10, IL-1β, IL-1RA, IL-4), and metabolic parameters (amylase, insulin, lactate). The fact that these parameters can be measured from both blood and saliva samples has increased the use of non-invasive methods in exercise physiology studies.

The level of physical activity is directly related not only to biological systems but also to an individual's psychological health and lifestyle habits. Research shows that regular physical activity reduces levels of depression and improves quality of life. The positive effects of exercise on the immune system become more significant when considered in conjunction with an individual's general lifestyle habits (nutrition, sleep, stress levels, substance use, etc.). It is particularly known that individuals with depression have high cortisol levels and suppressed IgA levels. Therefore, depression levels and lifestyle habits are important variables that affect the physiological responses to exercise.

This study will compare the effects of aerobic and anaerobic exercise on hormonal, immunological, and metabolic biomarkers measured via blood and saliva samples in young individuals. Additionally, the participants' physical activity levels, depression levels, and general lifestyle habits will be evaluated to explore the relationship between these variables and biomarker profiles. Measurements will include levels of testosterone, progesterone, cortisol, IgA, alpha-amylase, insulin, lactate, and various inflammatory cytokines, assessed using the ELISA method. In this way, the biological effects of different types of exercise will be evaluated from both physiological and psychosocial perspectives.

The main aim of this study is to comparatively examine the effects of aerobic and anaerobic exercises on hormonal, immunological, and metabolic biomarkers measured through blood and saliva samples in young individuals. Additionally, the relationship between the participants' physical activity level, depression level, and general lifestyle habits (nutrition, sleep patterns, substance use, etc.) with these biomarkers will be investigated, as well as the potential modulatory effects on the physiological responses to exercise.

Being tested
Treadmill Exercise, Bicycle Exercise
Keywords
Exercise physiology, Aerobic and anaerobic exercis, Hormonal and immunological responses, Physical activity
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treadmill ExerciseDevice

    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.

  • Bicycle ExerciseDevice

    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.

Study groups in NCT07092969
Study groupRoleWhat they receive
Group I - Control Group:No interventionThis 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):ExperimentalParticipants 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.
Receives: Device: Treadmill Exercise
Group III - Bicycle Exercise (Wingate Anaerobic Test):ExperimentalThis 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.
Receives: Device: Bicycle Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Salivary Testosterone Level

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

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

  2. Change in Salivary Cortisol Level

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

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

  3. Change in Salivary Progesterone Level

    Salivary progesterone levels before and after exercise.

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

  4. Change in Salivary Alpha-Amylase Activity

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

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

  5. Change in Blood Lactate Level

    Lactate concentration in blood samples collected before and after exercise.

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

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

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

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

  7. Change in Salivary Immunoglobulin A (IgA)

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

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

Secondary outcomes (2)
  1. Change in Depression Score (Beck Depression Inventory-II)

    Assessment of participants' depressive symptoms using the validated Beck Depression Inventory-II (BDI-II).

    Measured: 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

  2. Change in Physical Activity Level (IPAQ-Short Form)

    Evaluation of participants' physical activity levels using the International Physical Activity Questionnaire - Short Form (IPAQ-SF), which estimates physical activity over the last 7 days in MET-minutes/week.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2025
  2. Study start15 Sep 2025 (estimated)
  3. Primary completion15 Mar 2026 (estimated)
  4. Study completion15 Sep 2026 (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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07092969
Sponsor's protocol ID
2
Other IDs
308-2025
Acronym
Biomarkers
Status last verified
Jul 2025
First submitted
21 Jul 2025
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33388079
  • 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.

    PubMed 10893431
  • 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.

    PubMed 17303714
  • 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.

    PubMed 29150166
  • 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.

    PubMed 29690792

Questions about this trial

What is this clinical trial studying?

A study testing Treadmill Exercise and Bicycle Exercise in people with Activity, Motor and Biomarkers, run by Sakarya Applied Sciences 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 2 inclusion and 3 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 Jul 2025. 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 Abdurrahim Yıldız, Doc.Dr. (+90 507 751 63 63, abdurrahimyildiz@subu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Salivary Testosterone Level (time frame: Time Frame: Baseline and immediately post-exercise Unit of Measure: pg/mL). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07092969, which also lists 5 linked publications.

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 Jul 2025.

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