Effect of Exercise on Clinical Symptoms, Cognitive Performance, and Quality of Life in Schizophrenia Patients Treated With Clozapine

Not Applicable

Recruiting

• Conditions: Exercise; Clozapine; Schizophrenia
• Interventions: Other: physical exercise

• Registration Number: NCT06573320
• Lead Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

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.

Detailed Description

The first developed atypical antipsychotic is clozapine. Its efficacy has been demonstrated in individuals with schizophrenia who have insufficient response to other antipsychotic therapies; nonetheless, its adverse effect profile is extensive. Among the antipsychotic medications now available, clozapine is not utilized as a first-line therapy because of major side effects such agranulocytosis. Increased salivation, sleepiness, weight gain, changes in blood pressure (sometimes an increase, sometimes a drop), elevated heart rate, dizziness, exhaustion, constipation, fever, and nocturnal enuresis are common adverse effects of clozapine usage.

Study Timeline

• Study Start: 2024-03-14
• Status Verified: 2024-08
• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-24
• Last Update Submitted: 2024-08-24
• Primary Completion: 2024-08-26
• Study First Posted: 2024-08-27
• Last Update Posted: 2024-08-27
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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,

Exclusion Criteria

• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
physical exercise group	physical exercise	physical exercise

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment (MOCA)	12 weeks	OCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.
Positive and Negative Syndrome Scale (PANSS)	12 weeks	To evaluate clinical symptoms, both the exercise and control groups will be assessed by using the Positive and Negative Syndrome Scale (PANSS)

Trial Locations

Locations (1)

Kartal Dr Lütfi Kırdar Şehir Hastanesi; 🇹🇷 İstanbul, Turkey