SchizophreniaNCT06572657
Comparison of the Effects of Aerobic Exercise and Computerized Cognitive Stimulation in Patients With Schizophrenia - A Randomized Controlled Trial
A study testing cognitive stimulation and physical exercise in people with Schizophrenia and Exercise, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Exercise, Computerized Cognitive Stimulation
- What is being tested?
- cognitive stimulation and physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2024to 6 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr Lütfi Kırdar Şehir Hastanesi
Istanbul
About this study
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.
Read the detailed description
The aim of this study was to compare the effects of computer-based cognitive stimulation and aerobic/strengthening exercises on symptom severity, cognition and depression in schizophrenia patients receiving community mental health center services.
- Conditions
- Schizophrenia, Exercise, Computerized Cognitive Stimulation
- Being tested
- cognitive stimulation, physical exercise
- Medical subject headings
- Schizophrenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive stimulationOther
cognitive stimulation
physical exerciseOther
physical exercise
| Study group | Role | What they receive |
|---|---|---|
| cognitive stimulation group | Experimental | cognitive stimulation Receives: Other: cognitive stimulation |
| physical exercise group | Experimental | physical exercise Receives: Other: physical exercise |
| control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment Scale
MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start2 Feb 2024
- Primary completion26 Aug 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İsmail Koç, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572657
- Sponsor's protocol ID
- İsmailK
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Aerobic Exercise and Computerized Cognitive Stimulation in Patients With Schizophrenia - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06572657
- Acronym / sponsor ID
- İsmailK
- Conditions
- Schizophrenia, Exercise, Computerized Cognitive Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this study was to compare the effects of computer-based cognitive stimulation and aerobic/strengthening exercises on symptom severity, cognition and depression in schizophrenia patients receiving community mental health center services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cognitive stimulation group | Experimental | Other: cognitive stimulationcognitive stimulation |
| physical exercise group | Experimental | Other: physical exercisephysical exercise |
| control group | No intervention | –no intervention |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive stimulationcognitive stimulation | Other | cognitive stimulation group |
| physical exercisephysical exercise | Other | physical exercise group |
Primary outcome
Montreal Cognitive Assessment Scale
Time frame: 12 weeks
MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.
Frontal Assessment Battery
Time frame: 12 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive stimulation and physical exercise in people with Schizophrenia and Exercise, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment Scale (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.