NCT06572657

Brief Summary

Schizophrenia is a chronic mental disorder characterized by the occurrence of both positive symptoms, such as hallucinations and delusions, and negative symptoms, such as apathy and withdrawal, repetition of cognitive skills and disorganization. There are approximately 20 million people with schizophrenia worldwide and this number will continue to increase every year.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Feb 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

February 2, 2024

Completed
7 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
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2024

Completed
Last Updated

September 19, 2025

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

August 23, 2024

Last Update Submit

September 15, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Montreal Cognitive Assessment Scale

    MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.

    12 weeks

  • Frontal Assessment Battery

    Frontal Assessment Battery consists of six subtests for assessing executive functions; the scale is scored from 0 to 18, with higher scores indicating better frontal functions.

    12 weeks

Study Arms (3)

cognitive stimulation group

EXPERIMENTAL

cognitive stimulation

Other: cognitive stimulation

physical exercise group

EXPERIMENTAL

physical exercise

Other: physical exercise

control group

NO INTERVENTION

no intervention

Interventions

cognitive stimulation

cognitive stimulation group

physical exercise

physical exercise group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals diagnosed with schizophrenia by a physician according to DSM-V criteria Patients treated at TRSM Individuals diagnosed with schizophrenia between the ages of 20-60

You may not qualify if:

  • Those who did not give 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 27, 2024

Study Start

February 2, 2024

Primary Completion

August 26, 2024

Study Completion

September 6, 2024

Last Updated

September 19, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations