Schizophrenia DisorderNCT07141966
Assessment of Physical Activity, Balance, Muscle Strength, and Cognitive Function in Patients Diagnosed With Schizophrenia
An observational study of Schizophrenia Disorder, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Schizophrenia is a serious mental health condition that affects individuals' thinking, perception, emotional responses, and behavior. Balance in schizophrenia patients is often related to motor skills, coordination, and postural control. Schizophrenia can cause functional changes in certain areas of the brain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia Disorder
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Aug 2025to 15 Sep 2025
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Schizophrenia
Who may be able to join
- Diagnosis of schizophrenia by a psychiatrist according to DSM-V
- aged between 18 and 65 years
- being clinically stable
- having received continuous pharmacological treatment for at least six months
- having the ability to understand and follow verbal and written instructions
Who cannot join
- major neurological disorders (e.g. epilepsy or Parkinson's disease)
- significant orthopaedic impairments affecting balance or strength
- substance use disorders (except nicotine)
- acute psychotic symptoms and severe intellectual disability
Trial locations and contacts
1 site in 1 country.
About this study
Schizophrenia is a serious mental health condition that affects individuals' thinking, perception, emotional responses, and behavior.
Balance in schizophrenia patients is often related to motor skills, coordination, and postural control.
Schizophrenia can cause functional changes in certain areas of the brain. These changes can affect motor functions.
Balance loss in schizophrenia patients can cause difficulties in daily living activities, increased risk of falls, and a decrease in overall quality of life. Therefore, the aim of this study is to evaluate physical activity, balance, muscle strength, and cognitive function in patients diagnosed with schizophrenia.
Read the detailed description
Schizophrenia is a serious mental health condition that affects individuals' thinking, perception, emotional responses, and behavior. Treatment for schizophrenia typically involves approaches such as medication and psychotherapy. Balance in schizophrenia patients is often related to motor skills, coordination, and postural control. Although schizophrenia is a mental health disorder, it can also affect patients' physical balance and motor function. Antipsychotic medications, which are frequently used in the treatment of schizophrenia, can have an effect on patients' motor skills. These medications can negatively affect balance in some patients.
Schizophrenia can cause functional changes in certain areas of the brain. These changes can affect motor functions. Hallucinations, which are commonly seen in patients with schizophrenia, can interfere with visual, auditory, or tactile perception, preventing the person from accurately perceiving their surroundings. This can negatively affect physical balance, as the person may not be able to accurately assess dangers in their surroundings or may misperceive their location or distances. Balance loss in schizophrenia patients can cause difficulties in daily living activities, increased risk of falls, and a decrease in overall quality of life. Therefore, the aim of this study is to evaluate physical activity, balance, muscle strength, and cognitive function in patients diagnosed with schizophrenia.
- Conditions
- Schizophrenia Disorder
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with schizophrenia | patients with schizophrenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire (IPAQ):
Used to assess an individual's physical activity level over the past 7 days. The International Physical Activity Questionnaire (IPAQ) consists of 4 questionnaires. There are long (5 independently asked activity areas) and short (4 general items) versions. The short version consists of questions about the time spent walking and engaging in moderate to vigorous and strenuous activities.
Measured: 2 weeks
Berg Balance Scale
Berg Balance Scale The scale, consisting of a total of 14 items, assesses patients' balance skills. Each item is scored on a scale of 0-4. 0 = unable to perform, 4 = normal performance. The maximum score is 56, and a high score indicates better balance skills. The physical therapist administers the test by providing the necessary instructions to the patient in a manner they can understand after the patient has rested. The choice of which foot to use in certain items should be left to the patient. The materials required for the test (stopwatch, measuring tape, chair, step, slippers) should be prepared before beginning the assessment.
Measured: 2 weeks
Handgrip Strength
Handgrip strength was assessed using the JTech Commander GripTrack™ hand dynamometer. Participants performed the measurement according to a standardized testing procedure, and grip strength was recorded in kilograms (kg). Higher values indicate greater handgrip strength.
Measured: 2 weeks
Mini Mental State Examination
The standardized version of the MMSE (Mini Mental State Examination) developed by Folstein et al. (1975) was adapted by Molloy and Standish (1997). The MMSE allows for cognitive assessment in a short period of time. In this regard, the MMSE is a short, easy-to-administer, and standardized test used to assess global cognitive level. The test is widely used to evaluate the cognitive status of elderly individuals. A validity and reliability study in the Turkish population was conducted by Güngen and colleagues (2002). In their study, Güngen and colleagues (2002) determined that the 23/24 cutoff value of the Standardized Mini Mental Test (SMMT) had a sensitivity of 0.91, a specificity of 0.95, an inter-rater reliability of r:0.99, and a kappa value of 0.92. As a result, it was determined that the Standardized Mini Mental Test is valid and reliable in the Turkish population.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start19 Aug 2025
- Primary completion30 Aug 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 35 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
- NCT07141966
- Sponsor's protocol ID
- Ismail KKoc
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 19 Aug 2026
- 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 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Physical Activity, Balance, Muscle Strength, and Cognitive Function in Patients Diagnosed With Schizophrenia
- ClinicalTrials.gov ID
- NCT07141966
- Acronym / sponsor ID
- Ismail KKoc
- Conditions
- Schizophrenia Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 26 Aug 2025 (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 serious mental health condition that affects individuals' thinking, perception, emotional responses, and behavior.
Balance in schizophrenia patients is often related to motor skills, coordination, and postural control.
Schizophrenia can cause functional changes in certain areas of the brain. These changes can affect motor functions.
Balance loss in schizophrenia patients can cause difficulties in daily living activities, increased risk of falls, and a decrease in overall quality of life. Therefore, the aim of this study is to evaluate physical activity, balance, muscle strength, and cognitive function in patients diagnosed with schizophrenia.
Detailed description
Schizophrenia is a serious mental health condition that affects individuals' thinking, perception, emotional responses, and behavior. Treatment for schizophrenia typically involves approaches such as medication and psychotherapy. Balance in schizophrenia patients is often related to motor skills, coordination, and postural control. Although schizophrenia is a mental health disorder, it can also affect patients' physical balance and motor function. Antipsychotic medications, which are frequently used in the treatment of schizophrenia, can have an effect on patients' motor skills. These medications can negatively affect balance in some patients.
Schizophrenia can cause functional changes in certain areas of the brain. These changes can affect motor functions. Hallucinations, which are commonly seen in patients with schizophrenia, can interfere with visual, auditory, or tactile perception, preventing the person from accurately perceiving their surroundings. This can negatively affect physical balance, as the person may not be able to accurately assess dangers in their surroundings or may misperceive their location or distances. Balance loss in schizophrenia patients can cause difficulties in daily living activities, increased risk of falls, and a decrease in overall quality of life. Therefore, the aim of this study is to evaluate physical activity, balance, muscle strength, and cognitive function in patients diagnosed with schizophrenia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with schizophrenia | – | –patients with schizophrenia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Schizophrenia
Key inclusion criteria (5 listed)
- Diagnosis of schizophrenia by a psychiatrist according to DSM-V
- aged between 18 and 65 years
- being clinically stable
- having received continuous pharmacological treatment for at least six months
- having the ability to understand and follow verbal and written instructions
Key exclusion criteria (4 listed)
- major neurological disorders (e.g. epilepsy or Parkinson's disease)
- significant orthopaedic impairments affecting balance or strength
- substance use disorders (except nicotine)
- acute psychotic symptoms and severe intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
International Physical Activity Questionnaire (IPAQ):
Time frame: 2 weeks
Used to assess an individual's physical activity level over the past 7 days. The International Physical Activity Questionnaire (IPAQ) consists of 4 questionnaires. There are long (5 independently asked activity areas) and short (4 general items) versions. The short version consists of questions about the time spent walking and engaging in moderate to vigorous and strenuous activities.
Berg Balance Scale
Time frame: 2 weeks
Berg Balance Scale The scale, consisting of a total of 14 items, assesses patients' balance skills. Each item is scored on a scale of 0-4. 0 = unable to perform, 4 = normal performance. The maximum score is 56, and a high score indicates better balance skills. The physical therapist administers the test by providing the necessary instructions to the patient in a manner they can understand after the patient has rested. The choice of which foot to use in certain items should be left to the patient. The materials required for the test (stopwatch, measuring tape, chair, step, slippers) should be prepared before beginning the assessment.
Handgrip Strength
Time frame: 2 weeks
Handgrip strength was assessed using the JTech Commander GripTrack™ hand dynamometer. Participants performed the measurement according to a standardized testing procedure, and grip strength was recorded in kilograms (kg). Higher values indicate greater handgrip strength.
Mini Mental State Examination
Time frame: 2 weeks
The standardized version of the MMSE (Mini Mental State Examination) developed by Folstein et al. (1975) was adapted by Molloy and Standish (1997). The MMSE allows for cognitive assessment in a short period of time. In this regard, the MMSE is a short, easy-to-administer, and standardized test used to assess global cognitive level. The test is widely used to evaluate the cognitive status of elderly individuals. A validity and reliability study in the Turkish population was conducted by Güngen and colleagues (2002). In their study, Güngen and colleagues (2002) determined that the 23/24 cutoff value of the Standardized Mini Mental Test (SMMT) had a sensitivity of 0.91, a specificity of 0.95, an inter-rater reliability of r:0.99, and a kappa value of 0.92. As a result, it was determined that the Standardized Mini Mental Test is valid and reliable in the Turkish population.
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 Aug 2026.
- 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?
An observational study of Schizophrenia Disorder, 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 5 inclusion and 4 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 Aug 2026. 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?
International Physical Activity Questionnaire (IPAQ): (time frame: 2 weeks). The study lists 4 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 Aug 2026.