NCT07062783

Brief 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 stress (TAS, TOS, MDA, and F2-isoprostane) that are thought to play a role in the pathophysiology of depression.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

August 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

September 5, 2025

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

July 3, 2025

Last Update Submit

September 4, 2025

Conditions

Keywords

DepressionAerobic exerciseOxidative stressGrowth factors

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From enrollment to the end of treatment at 3 weeks

Study Arms (2)

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.

Other: Breathing exerciseOther: Aerobic Exercise

Control group

NO INTERVENTION

The control group continued their routine lives, and at the end of three weeks

Interventions

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.

Exercise Group

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.

Exercise Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals with chronic conditions accompanying depression,
  • Those with walking difficulties
  • Those with respiratory system disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Merkez, 43020, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Breathing ExercisesExercise

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Hatice Solak, Assos. Prof

CONTACT

Vedat Kurt, Assos. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 14, 2025

Study Start

August 1, 2024

Primary Completion

August 31, 2025

Study Completion

September 30, 2025

Last Updated

September 5, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations