SchizophreniaNCT07173465
Comparison of the Effects of Physical Activity and Virtual Reality Training in Patients With Schizophrenia
A study testing Virtual Reality (VR), Physical Activity (PA group) and occupational therapy in people with Schizophrenia and Balance; Distorted, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The current study aims to compare the effects of physical activity and Virtual Reality training on physical function, cognition and quality of life in patients with Schizophrenia. It is hypothesized in the literature that both physical activity and VR may have positive effects on the symptoms of PwS. Read more about this study
- Who is it for?
- Ages 20 to 77 years
- Conditions the study is for
- Schizophrenia, Balance; Distorted, Cognitive Impairment
- What is being tested?
- Virtual Reality (VR), Physical Activity (PA group) and occupational therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 May 2023to 2 Aug 2023
- 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 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 20 and 77 years old.
- Willing to participate in research.
- Diagnosed with Schizophrenia according to the criteria defined in the DSM-IV by a psychiatrist.
- Able to attend Community Mental Health Center regularly.
- Not diagnosed with a mental disability, alcoholism, or drug addiction.
- Scoring 40 points or higher on the GAF test, indicating a non-severe mental state.
- Capable of fully understanding the purpose and content of the research.
- Able to participate in physical activity that requires musculoskeletal movement without difficulty, as determined by self-report.
Who cannot join
- Have significant cardiovascular, neuromuscular, endocrine, or other disorders that might prevent safe participation in the study.
- Have a diagnosis of alcohol or substance abuse.
- Have a secondary diagnosis of neurological disease or disease associated with the consumption of toxins, addiction to technology, or compulsive gambling.
- Unable to read, understand, or respond to assessment tests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Physical Activity and Virtual Reality Training on Physical Function, Cognition and Quality of Life in Patients With Schizophrenia
The current study aims to compare the effects of physical activity and Virtual Reality training on physical function, cognition and quality of life in patients with Schizophrenia.
It is hypothesized in the literature that both physical activity and VR may have positive effects on the symptoms of PwS. Still, which modality may be more effective has yet to be discovered. By comparing the effects of physical activity and VR training on the symptoms of PwS, this study may provide valuable insights into the potential benefits of these interventions and inform the development of effective treatment strategies for PwS.
Our study will discuss this relationship, and the results will be presented.
Read the detailed description
1 INTRODUCTION AND PURPOSE
Schizophrenia is a debilitating mental disorder characterized by disruptions in thinking, perception, emotions, and social functioning (1). Patients with schizophrenia (PwS) often experience impairments in physical function, cognition, and quality of life, which can significantly impact their overall well-being. As part of the pursuit to enhance treatment outcomes, researchers, including physical therapists, have explored various adjunctive therapies that can potentially alleviate these impairments. In this study, we aim to compare the effects of physical activity (PA) and virtual reality (VR) training on physical function, cognition, and quality of life in Patients with schizophrenia (PwS), compared to a control group that undergoes regular occupational therapy.
1.1 Background Physical activity has been recognized as a beneficial intervention for individuals with mental disorders, including schizophrenia (2). Engaging in regular physical activity has been associated with improved physical fitness, cardiovascular health, and muscle strength. Furthermore, studies have shown that physical activity can positively influence cognitive function, including attention, memory, and executive functions, in individuals with schizophrenia (2, 3). These improvements in physical and cognitive domains can potentially lead to enhanced quality of life for these individuals.
Virtual reality training, on the other hand, is an emerging therapeutic approach that provides immersive and interactive experiences through computer-generated simulations. While the benefits of physical activity have been extensively studied in schizophrenia, research investigating the specific effects of virtual reality training in this population is limited (4). There is a need to explore the potential benefits of VR in improving physical function, cognition, and quality of life in individuals with schizophrenia to expand our understanding of its therapeutic value.
1.2 Significance Understanding the comparative effects of physical activity and virtual reality training on physical function, cognition, and quality of life in Patients with schizophrenia (PwS), in comparison to the control group undergoing regular occupational therapy, holds significant importance. By comparing these interventions, we can identify their relative effectiveness and potential benefits in addressing the impairments associated with schizophrenia. This knowledge can inform clinicians, researchers, and healthcare professionals, including physical therapists, in making evidence-based decisions regarding the use of these interventions in clinical practice. Additionally, it may contribute to the development of personalized treatment approaches that optimize outcomes and improve the overall well-being of individuals with schizophrenia.
1.3 Overview This study describes a comparative analysis of three groups: a physical activity intervention group, a virtual reality training intervention group, and a control group that undergoes regular occupational therapy at the center. The study will recruit a sample of individuals diagnosed with schizophrenia and randomly assign them to one of the three groups. Assessments of physical function, cognitive performance, and quality of life will be conducted before and after the interventions to evaluate the effectiveness of each approach. The findings of this study will contribute to the existing literature and inform the development of evidence-based interventions for individuals with schizophrenia, particularly in the context of physical therapy.
- Conditions
- Schizophrenia, Balance; Distorted, Cognitive Impairment
- Being tested
- Virtual Reality (VR), Physical Activity (PA group), occupational therapy
- Keywords
- schizophrenia, Virtual reality, Cognition
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR)Device
Participants will engage in the VR gaming intervention three times a week for 12 weeks. Each session will last approximately 45 minutes, providing ample gameplay, instruction, and debriefing time.
Physical Activity (PA group)Other
The intervention includes a 5-minute warm-up, 10 minutes of strengthening exercises (lunges and squats), 20 minutes of balance and cardiovascular endurance activities (HIIT exercises), 20 minutes of aerobic exercises (stationary bike and dancing), and a 5-minute cool-down with breathing control. Participants also continue with personalized occupational therapy to enhance their functional abilities.
occupational therapyOther
the group will undergo their normal occupational therapy activities that include drawing, coloring, mathematical problems as well as solving mazes
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity (PA group) | Active comparator | The program will be comprised of
(5 minutes) Warm-up (5 minutes) Strengthening exercises (Lunges- squats) (10 minutes) Balance and Cardiovascular endurance (HIIT-penguin seesaw- table tilt) (15 minutes) Aerobic ex (stationary bike- dancing) (5 minutes) Cool down exercises and breathing control. In addition to all these, the individuals will continue occupational therapy. Receives: Device: Virtual Reality (VR) |
| Virtual Reality (VR) group | Active comparator | Group 2 Virtual Reality (VR) group will undergo 45 minutes of the Nintendo Wii-FitTM game. First of all, it will start with games that include warm-up exercises ( 5 min) and then continue with games that include strengthening (5 min), balance (5 min) and aerobic exercises (15 min).
Finally, the treatment will be terminated with games, including cool-down (5 min) exercises. In addition to all these, the individuals will continue occupational therapy. Receives: Other: Physical Activity (PA group) |
| control group | Sham comparator | This group will undergo regular occupational therapy at the treatment center Receives: Other: occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simple Physical Activity Questionnaire
The SIMPAQ is a five-point evaluation tool designed to assess physical activity and sedentary behavior in individuals with common mental disorders.
Measured: 12 weeks
Six minute walking test
The 6-Minute Walk Test (6MWT) is a standardized physical performance test that measures the distance an individual can walk on a flat, hard surface in six minutes. It provides an objective assessment of functional exercise capacity, endurance, and overall mobility in daily life activities.
Measured: 12 weeks
The Mini-Mental State Examination
The Mini-Mental State Examination (MMSE) is commonly used as a screening tool to assess cognitive function and detect cognitive impairments. While the MMSE is not specifically designed to evaluate cognitive deficits associated with schizophrenia, it can still provide some insights into general cognitive functioning in individuals with schizophrenia.
In schizophrenia, cognitive impairments are frequently observed across various cognitive domains, including attention, working memory, executive function, verbal fluency, and processing speed. These cognitive deficits can significantly impact daily functioning, quality of life, and overall outcomes for individuals with schizophrenia.
Measured: 12 weeks
SF-36
It is a widely used self-report questionnaire that assesses health-related quality of life (HRQoL)
Measured: 12 weeks
Berg Balance Scale
Berg Balance Scale (BBS) is a standardized clinical test used to evaluate static and dynamic balance. It consists of 14 functional tasks, such as standing, reaching, and turning, each scored on a 5-point scale. The total score provides an objective measure of balance performance and fall risk in individuals.
Measured: 12 weeks
Time Up and Go Test
The Timed Up and Go Test (TUG) is a standardized assessment that measures functional mobility. Participants are asked to stand up from a seated position, walk three meters, turn around, walk back, and sit down. The time taken to complete the task is recorded, providing an objective measure of mobility, balance, walking ability, and fall risk
Measured: 12 weeks
Sit to Stand test
"The Sit-to-Stand Test is a functional performance measure used to assess lower limb strength, endurance, and mobility. Participants are asked to rise from a seated position to a full stand and return to sitting, repeated either for a set number of repetitions (e.g., five times) or within a fixed time period (e.g., 30 seconds). The total time or number of repetitions provides an objective indicator of lower body function and fall risk.
Measured: 12 weeks
Grip strength
he Grip Strength Test is a standardized assessment of hand and forearm muscle strength. Participants are instructed to squeeze a calibrated hand dynamometer with maximum effort, usually in a seated position with the elbow at 90 degrees. The highest value from repeated trials is recorded, providing an objective measure of upper extremity strength and overall functional capacity
Measured: 12 weeks
Secondary outcomes (3)
Calgary Depression Scale
The Calgary Depression Scale was developed by Addington et al. (1994) as a tool to measure the presence and severity of depressive symptoms in patients with schizophrenia.
Measured: 12 weeks
Katz Activities of Daily Living Scale
The Katz Index of Independence in ADLs (Katz Index) is a widely used tool to assess basic activities of daily living (ADLs) such as bathing, dressing, toileting, transferring, continence, and feeding.
Measured: 12 weeks
Lawton Brody Instrumental Activities of Daily Living Scale
IADL is a commonly used tool to assess the level of independence in instrumental activities of daily living in older adults.
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 posted15 Sep 2025
- Study start26 May 2023
- Primary completion2 Jul 2023
- Study completion2 Aug 2023
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
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173465
- Sponsor's protocol ID
- 64-2023
- Status last verified
- Sep 2025
- First submitted
- 25 May 2023
- Last updated
- 15 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Physical Activity and Virtual Reality Training on Physical Function, Cognition and Quality of Life in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT07173465
- Acronym / sponsor ID
- 64-2023
- Conditions
- Schizophrenia, Balance; Distorted, Cognitive Impairment
- Keywords
- schizophrenia, Virtual reality, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 26 May 2023 (actual)
- Primary completion
- 2 Jul 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 15 Sep 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.
The current study aims to compare the effects of physical activity and Virtual Reality training on physical function, cognition and quality of life in patients with Schizophrenia.
It is hypothesized in the literature that both physical activity and VR may have positive effects on the symptoms of PwS. Still, which modality may be more effective has yet to be discovered. By comparing the effects of physical activity and VR training on the symptoms of PwS, this study may provide valuable insights into the potential benefits of these interventions and inform the development of effective treatment strategies for PwS.
Our study will discuss this relationship, and the results will be presented.
Detailed description
1 INTRODUCTION AND PURPOSE
Schizophrenia is a debilitating mental disorder characterized by disruptions in thinking, perception, emotions, and social functioning (1). Patients with schizophrenia (PwS) often experience impairments in physical function, cognition, and quality of life, which can significantly impact their overall well-being. As part of the pursuit to enhance treatment outcomes, researchers, including physical therapists, have explored various adjunctive therapies that can potentially alleviate these impairments. In this study, we aim to compare the effects of physical activity (PA) and virtual reality (VR) training on physical function, cognition, and quality of life in Patients with schizophrenia (PwS), compared to a control group that undergoes regular occupational therapy.
1.1 Background Physical activity has been recognized as a beneficial intervention for individuals with mental disorders, including schizophrenia (2). Engaging in regular physical activity has been associated with improved physical fitness, cardiovascular health, and muscle strength. Furthermore, studies have shown that physical activity can positively influence cognitive function, including attention, memory, and executive functions, in individuals with schizophrenia (2, 3). These improvements in physical and cognitive domains can potentially lead to enhanced quality of life for these individuals.
Virtual reality training, on the other hand, is an emerging therapeutic approach that provides immersive and interactive experiences through computer-generated simulations. While the benefits of physical activity have been extensively studied in schizophrenia, research investigating the specific effects of virtual reality training in this population is limited (4). There is a need to explore the potential benefits of VR in improving physical function, cognition, and quality of life in individuals with schizophrenia to expand our understanding of its therapeutic value.
1.2 Significance Understanding the comparative effects of physical activity and virtual reality training on physical function, cognition, and quality of life in Patients with schizophrenia (PwS), in comparison to the control group undergoing regular occupational therapy, holds significant importance. By comparing these interventions, we can identify their relative effectiveness and potential benefits in addressing the impairments associated with schizophrenia. This knowledge can inform clinicians, researchers, and healthcare professionals, including physical therapists, in making evidence-based decisions regarding the use of these interventions in clinical practice. Additionally, it may contribute to the development of personalized treatment approaches that optimize outcomes and improve the overall well-being of individuals with schizophrenia.
1.3 Overview This study describes a comparative analysis of three groups: a physical activity intervention group, a virtual reality training intervention group, and a control group that undergoes regular occupational therapy at the center. The study will recruit a sample of individuals diagnosed with schizophrenia and randomly assign them to one of the three groups. Assessments of physical function, cognitive performance, and quality of life will be conducted before and after the interventions to evaluate the effectiveness of each approach. The findings of this study will contribute to the existing literature and inform the development of evidence-based interventions for individuals with schizophrenia, particularly in the context of physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Physical Activity (PA group) | Active comparator | Device: Virtual Reality (VR)The program will be comprised of (5 minutes) Warm-up (5 minutes) Strengthening exercises (Lunges- squats) (10 minutes) Balance and Cardiovascular endurance (HIIT-penguin seesaw- table tilt) (15 minutes) Aerobic ex (stationary bike- dancing) (5 minutes) Cool down exercises and breathing control. In addition to all these, the individuals will continue occupational therapy. |
| Virtual Reality (VR) group | Active comparator | Other: Physical Activity (PA group)Group 2 Virtual Reality (VR) group will undergo 45 minutes of the Nintendo Wii-FitTM game. First of all, it will start with games that include warm-up exercises ( 5 min) and then continue with games that include strengthening (5 min), balance (5 min) and aerobic exercises (15 min). Finally, the treatment will be terminated with games, including cool-down (5 min) exercises. In addition to all these, the individuals will continue occupational therapy. |
| control group | Sham comparator | Other: occupational therapyThis group will undergo regular occupational therapy at the treatment center |
Who may qualify
- Ages
- 20 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Between the ages of 20 and 77 years old.
- Willing to participate in research.
- Diagnosed with Schizophrenia according to the criteria defined in the DSM-IV by a psychiatrist.
- Able to attend Community Mental Health Center regularly.
- Not diagnosed with a mental disability, alcoholism, or drug addiction.
Key exclusion criteria (4 listed)
- Have significant cardiovascular, neuromuscular, endocrine, or other disorders that might prevent safe participation in the study.
- Have a diagnosis of alcohol or substance abuse.
- Have a secondary diagnosis of neurological disease or disease associated with the consumption of toxins, addiction to technology, or compulsive gambling.
- Unable to read, understand, or respond to assessment tests.
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 |
|---|---|---|
| Virtual Reality (VR)Participants will engage in the VR gaming intervention three times a week for 12 weeks. Each session will last approximately 45 minutes, providing ample gameplay, instruction, and debriefing time. | Device | Physical Activity (PA group) |
| Physical Activity (PA group)The intervention includes a 5-minute warm-up, 10 minutes of strengthening exercises (lunges and squats), 20 minutes of balance and cardiovascular endurance activities (HIIT exercises), 20 minutes of aerobic exercises (stationary bike and dancing), and a 5-minute cool-down with breathing control. Participants also continue with personalized occupational therapy to enhance their functional abilities. | Other | Virtual Reality (VR) group |
| occupational therapythe group will undergo their normal occupational therapy activities that include drawing, coloring, mathematical problems as well as solving mazes | Other | control group |
Primary outcome
Simple Physical Activity Questionnaire
Time frame: 12 weeks
The SIMPAQ is a five-point evaluation tool designed to assess physical activity and sedentary behavior in individuals with common mental disorders.
Six minute walking test
Time frame: 12 weeks
The 6-Minute Walk Test (6MWT) is a standardized physical performance test that measures the distance an individual can walk on a flat, hard surface in six minutes. It provides an objective assessment of functional exercise capacity, endurance, and overall mobility in daily life activities.
The Mini-Mental State Examination
Time frame: 12 weeks
The Mini-Mental State Examination (MMSE) is commonly used as a screening tool to assess cognitive function and detect cognitive impairments. While the MMSE is not specifically designed to evaluate cognitive deficits associated with schizophrenia, it can still provide some insights into general cognitive functioning in individuals with schizophrenia. In schizophrenia, cognitive impairments are frequently observed across various cognitive domains, including attention, working memory, executive function, verbal fluency, and processing speed. These cognitive deficits can significantly impact daily functioning, quality of life, and overall outcomes for individuals with schizophrenia.
SF-36
Time frame: 12 weeks
It is a widely used self-report questionnaire that assesses health-related quality of life (HRQoL)
Berg Balance Scale
Time frame: 12 weeks
Berg Balance Scale (BBS) is a standardized clinical test used to evaluate static and dynamic balance. It consists of 14 functional tasks, such as standing, reaching, and turning, each scored on a 5-point scale. The total score provides an objective measure of balance performance and fall risk in individuals.
Time Up and Go Test
Time frame: 12 weeks
The Timed Up and Go Test (TUG) is a standardized assessment that measures functional mobility. Participants are asked to stand up from a seated position, walk three meters, turn around, walk back, and sit down. The time taken to complete the task is recorded, providing an objective measure of mobility, balance, walking ability, and fall risk
Sit to Stand test
Time frame: 12 weeks
"The Sit-to-Stand Test is a functional performance measure used to assess lower limb strength, endurance, and mobility. Participants are asked to rise from a seated position to a full stand and return to sitting, repeated either for a set number of repetitions (e.g., five times) or within a fixed time period (e.g., 30 seconds). The total time or number of repetitions provides an objective indicator of lower body function and fall risk.
Grip strength
Time frame: 12 weeks
he Grip Strength Test is a standardized assessment of hand and forearm muscle strength. Participants are instructed to squeeze a calibrated hand dynamometer with maximum effort, usually in a seated position with the elbow at 90 degrees. The highest value from repeated trials is recorded, providing an objective measure of upper extremity strength and overall functional capacity
3 secondary outcomes
Calgary Depression Scale
Time frame: 12 weeks
Katz Activities of Daily Living Scale
Time frame: 12 weeks
Lawton Brody Instrumental Activities of Daily Living Scale
Time frame: 12 weeks
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 15 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 Virtual Reality (VR), Physical Activity (PA group) and occupational therapy in people with Schizophrenia and Balance; Distorted, run by Yeditepe University 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 8 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 15 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. Some participants in this study may receive a placebo. 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?
Simple Physical Activity Questionnaire (time frame: 12 weeks). The study lists 8 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 15 Sep 2025.