NCT06574893

Brief Summary

Mental health is defined as a state of well-being in which a person can realize their talents, cope with the normal stresses of life, and support society by working efficiently and productively. In other words, mental health is a dynamic internal balance that enables individuals to use their diversity of skills in harmony with the universal values of society.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable schizophrenia

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

May 4, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2024

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2025

Completed
Last Updated

August 19, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

August 23, 2024

Last Update Submit

August 13, 2025

Conditions

SchizophreniaPhysical Exercise

Outcome Measures

Primary Outcomes (2)

  • sociodemographic characteristics.

    It will be asked to fill out a structured questionnaire covering their sociodemographic characteristics.

    12 weeks

  • simple inflammatory markers

    Index Calculation Based on Complete Blood Count

    12 weeks

Secondary Outcomes (1)

  • Positive and Negative Syndrome Scale

    12 weeks

Study Arms (2)

physical exercise group

EXPERIMENTAL

physical exercise

Other: physical exercise

control group

NO INTERVENTION

no intervention

Interventions

physical exerciseOTHER

physical exercise

physical exercise group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals diagnosed with schizophrenia by a physician according to DSM-V criteria
  • Individuals with schizophrenia who are 18 -55 years

You may not qualify if:

  • Those who do not consent to participate in the study Patients with a diagnosis other than schizophrenia Pregnancy Patients with chronic metabolic diseases such as diabetes, heart problems and cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Dr Lütfi Kırdar Şehir Hastanesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SchizophreniaMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 23, 2024

First Posted

August 28, 2024

Study Start

May 4, 2024

Primary Completion

August 26, 2024

Study Completion

March 12, 2025

Last Updated

August 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)