- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07173465
- Original Trial
Comparison of the Effects of Physical Activity and Virtual Reality Training in Patients With Schizophrenia
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Kartal Dr Lutfi Kirdar City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
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 |
|---|---|
|
Active Comparator: Physical Activity (PA group)
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. |
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.
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|
Active Comparator: Virtual Reality (VR) 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. |
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.
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Sham Comparator: control group
This group will undergo regular occupational therapy at the treatment center
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the group will undergo their normal occupational therapy activities that include drawing, coloring, mathematical problems as well as solving mazes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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12 weeks
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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.
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12 weeks
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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. |
12 weeks
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SF-36
Time Frame: 12 weeks
|
It is a widely used self-report questionnaire that assesses health-related quality of life (HRQoL)
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12 weeks
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Berg Balance Scale
Time Frame: 12 weeks
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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.
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12 weeks
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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
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12 weeks
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Sit to Stand test
Time Frame: 12 weeks
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"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.
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12 weeks
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Grip strength
Time Frame: 12 weeks
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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
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Calgary Depression Scale
Time Frame: 12 weeks
|
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.
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12 weeks
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Katz Activities of Daily Living Scale
Time Frame: 12 weeks
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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.
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12 weeks
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Lawton Brody Instrumental Activities of Daily Living Scale
Time Frame: 12 weeks
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IADL is a commonly used tool to assess the level of independence in instrumental activities of daily living in older adults.
|
12 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Schizophrenia Spectrum and Other Psychotic Disorders
- Mental Disorders
- Neurocognitive Disorders
- Cognition Disorders
- Schizophrenia
- Cognitive Dysfunction
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Patient Care
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Exercise
- Occupational Therapy
Other Study ID Numbers
- 64-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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