NCT06573320

Brief Summary

This prospective study aims to investigate the effects of exercise on clinical symptoms, cognitive performance, and quality of life in schizophrenia patients treated with Clozapine.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable schizophrenia

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

March 14, 2024

Completed
5 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
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

August 23, 2024

Last Update Submit

August 24, 2024

Conditions

SchizophreniaClozapineExercise

Outcome Measures

Primary Outcomes (2)

  • Montreal Cognitive Assessment (MOCA)

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

    12 weeks

  • Positive and Negative Syndrome Scale (PANSS)

    To evaluate clinical symptoms, both the exercise and control groups will be assessed by using the Positive and Negative Syndrome Scale (PANSS)

    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 - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients treated who were diagnosed with schizophrenia according to DSM-V criteria by psychiatrist at the Turkish Ministry of Health Kartal Dr. Lütfi Kırdar City Hospital
  • using a therapeutic dose of 300-500 mg/day of clozapine,

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Dr Lütfi Kırdar Şehir Hastanesi

Istanbul, Turkey (Türkiye)

RECRUITING

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

Central Study Contacts

Ebru Akbuga Koc

CONTACT

0216ebruakbuga@gmail.com

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

March 14, 2024

Primary Completion

August 26, 2024

Study Completion

August 31, 2024

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)