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

August 24, 2024 updated by: İsmail Koç, Dr. Lutfi Kirdar Kartal Training and Research Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • İstanbul, Turkey
        • Recruiting
        • Kartal Dr Lütfi Kırdar Şehir Hastanesi
        • Contact:
          • Kartal Dr Lütfi Kırdar Şehir Hastanesi
        • Principal Investigator:
          • İsmail Koç
        • Principal Investigator:
          • Ebru Akbuğa Koç

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
no intervention
Experimental: physical exercise group
physical exercise
Other: physical exercise
physical exercise

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2024

Primary Completion (Estimated)

August 26, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

August 24, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 24, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Keah

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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