Major DepressionNCT07062783
Effect of Aerobic Exercise on Biomarkers in Depression
A study testing Breathing exercise and Aerobic Exercise in people with Major Depression, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate changes in the levels of biomarkers (IGF-1, FGF2, and EGF) involved in neuron development in patients diagnosed with major depression through the effects of breathing exercises and aerobic exercise, as well as to examine the levels of biomarkers (TNF-α, IL-6, and IL-1) and oxidative… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Breathing exercise and Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals who volunteer to participate in the study,
- Between the ages of 18 and 40,
- Have been diagnosed with clinical depression by a psychiatrist according to DSM-5 criteria
Who cannot join
- Individuals with chronic conditions accompanying depression,
- Those with walking difficulties
- Those with respiratory system disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, Merkez, 43020
About this study
Official title: The Effect of Respiratory and Aerobic Exercises on Neuroprotective and Inflammation Biomarkers in Patients Diagnosed With Major Depression
This study aims to investigate changes in the levels of biomarkers (IGF-1, FGF2, and EGF) involved in neuron development in patients diagnosed with major depression through the effects of breathing exercises and aerobic exercise, as well as to examine the levels of biomarkers (TNF-α, IL-6, and IL-1) and oxidative stress (TAS, TOS, MDA, and F2-isoprostane) that are thought to play a role in the pathophysiology of depression.
- Conditions
- Major Depression
- Being tested
- Breathing exercise, Aerobic Exercise
- Keywords
- Depression, Aerobic exercise, Oxidative stress, Growth factors
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exerciseOther
Volunteers participating in the study who were included in the experimental group performed breathing exercises every day for three weeks. They were taught to focus their attention on the hand on their abdominal area while breathing slowly through their nose and to increase abdominal movement while reducing chest movement. They were warned that during inspiration, as air filled their lungs, the hand on their abdomen should rise upward and the hand on their chest should not move excessively. Participants continued the training until they performed the exercise correctly. The diaphragmatic breathing exercise was performed for 10 minutes in the supine position during the first week, in the semi-sitting and/or sitting position during the second week, and in the standing position during the final week.
Aerobic ExerciseOther
The ratios determined as reference values for walking training in healthy adults (reference value for women = (2.11*height) - (2.29*body weight) - (5.78*age) + 667 meters - reference value for men = (7.57*height) - (1.76*body weight) - (5.0 2*age) - 309 meters) was performed at 80% intensity for at least 30 minutes on at least 3 days a week for 3 weeks. Aerobic exercise was considered for 3 weeks to facilitate adaptation to exercise and sustainability.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Those included in the experimental group continued diaphragmatic breathing exercises every day for three weeks and walking exercises at least three days a week. Receives: Other: Breathing exercise; Other: Aerobic Exercise |
| Control group | No intervention | The control group continued their routine lives, and at the end of three weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress biomarkers
It has been reported that the interaction between oxidative stress and the immune system is important, and that activated immune inflammatory pathways can trigger oxidative stress. In our study, an ELISA test will be conducted to investigate how exercise affects the levels of oxidative stress (TAS, TOS, MDA, and F2-isoprostane) biomarkers, which play a role in the pathophysiology of depression.
Measured: From enrollment to the end of treatment at 3 weeks
Proinflmatuar sytokines
It is believed that increased production of key proinflammatory cytokines such as interleukin tumor necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), and interleukin-1 (IL-1) and acute phase reactants plays an important role in the development of depression as a result of immune system involvement.
In our study, an ELISA test will be conducted to investigate how exercise affects the levels of inflammation (TNF-α, IL-6, IL-1) which play a role in the pathophysiology of depression.
Measured: From enrollment to the end of treatment at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Aug 2024
- Primary completion31 Aug 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Kutahya Health Sciences University Scientific Research Projects Coordination Unit
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062783
- Sponsor's protocol ID
- DAE1
- Status last verified
- May 2025
- First submitted
- 3 Jul 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Respiratory and Aerobic Exercises on Neuroprotective and Inflammation Biomarkers in Patients Diagnosed With Major Depression
- ClinicalTrials.gov ID
- NCT07062783
- Acronym / sponsor ID
- DAE1
- Conditions
- Major Depression
- Keywords
- Depression, Aerobic exercise, Oxidative stress, Growth factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Collaborators
- Kutahya Health Sciences University Scientific Research Projects Coordination Unit
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate changes in the levels of biomarkers (IGF-1, FGF2, and EGF) involved in neuron development in patients diagnosed with major depression through the effects of breathing exercises and aerobic exercise, as well as to examine the levels of biomarkers (TNF-α, IL-6, and IL-1) and oxidative stress (TAS, TOS, MDA, and F2-isoprostane) that are thought to play a role in the pathophysiology of depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Breathing exercise, Other: Aerobic ExerciseThose included in the experimental group continued diaphragmatic breathing exercises every day for three weeks and walking exercises at least three days a week. |
| Control group | No intervention | –The control group continued their routine lives, and at the end of three weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals who volunteer to participate in the study,
- Between the ages of 18 and 40,
- Have been diagnosed with clinical depression by a psychiatrist according to DSM-5 criteria
Key exclusion criteria (3 listed)
- Individuals with chronic conditions accompanying depression,
- Those with walking difficulties
- Those with respiratory system disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing exerciseVolunteers participating in the study who were included in the experimental group performed breathing exercises every day for three weeks. They were taught to focus their attention on the hand on their abdominal area while breathing slowly through their nose and to increase abdominal movement while reducing chest movement. They were warned that during inspiration, as air filled their lungs, the hand on their abdomen should rise upward and the hand on their chest should not move excessively. Participants continued the training until they performed the exercise correctly. The diaphragmatic breathing exercise was performed for 10 minutes in the supine position during the first week, in the semi-sitting and/or sitting position during the second week, and in the standing position during the final week. | Other | Exercise Group |
| Aerobic ExerciseThe ratios determined as reference values for walking training in healthy adults (reference value for women = (2.11*height) - (2.29*body weight) - (5.78*age) + 667 meters - reference value for men = (7.57*height) - (1.76*body weight) - (5.0 2*age) - 309 meters) was performed at 80% intensity for at least 30 minutes on at least 3 days a week for 3 weeks. Aerobic exercise was considered for 3 weeks to facilitate adaptation to exercise and sustainability. | Other | Exercise Group |
Primary outcome
Oxidative stress biomarkers
Time frame: From enrollment to the end of treatment at 3 weeks
It has been reported that the interaction between oxidative stress and the immune system is important, and that activated immune inflammatory pathways can trigger oxidative stress. In our study, an ELISA test will be conducted to investigate how exercise affects the levels of oxidative stress (TAS, TOS, MDA, and F2-isoprostane) biomarkers, which play a role in the pathophysiology of depression.
Proinflmatuar sytokines
Time frame: From enrollment to the end of treatment at 3 weeks
It is believed that increased production of key proinflammatory cytokines such as interleukin tumor necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), and interleukin-1 (IL-1) and acute phase reactants plays an important role in the development of depression as a result of immune system involvement. In our study, an ELISA test will be conducted to investigate how exercise affects the levels of inflammation (TNF-α, IL-6, IL-1) which play a role in the pathophysiology of depression.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercise and Aerobic Exercise in people with Major Depression, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative stress biomarkers (time frame: From enrollment to the end of treatment at 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026.