Comparison of the Effects of Physical Activity and Virtual Reality Training in Patients With Schizophrenia

NCT07173465 | Completed

• 1 other identifier: 64-2023
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Schizophrenia; Balance; Distorted; Cognitive Impairment

Keywords

schizophrenia; Virtual reality; Cognition

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  12 weeks

• SF-36

  It is a widely used self-report questionnaire that assesses health-related quality of life (HRQoL)

  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.

  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

  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.

  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

  12 weeks

Secondary Outcomes (3)

• Calgary Depression Scale

  12 weeks

• Katz Activities of Daily Living Scale

  12 weeks

• Lawton Brody Instrumental Activities of Daily Living Scale

  12 weeks

Study Arms (3)

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.

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.

Other: Physical Activity (PA group)

control group

SHAM COMPARATOR

This group will undergo regular occupational therapy at the treatment center

Other: occupational therapy

Interventions

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)

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.

Virtual Reality (VR) group

occupational therapy OTHER

the group will undergo their normal occupational therapy activities that include drawing, coloring, mathematical problems as well as solving mazes

control group

Eligibility Criteria

• Age: 20 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yeditepe University: lead

Study Sites (1)

Kartal Dr Lutfi Kirdar City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Schizophrenia; Cognitive Dysfunction

Interventions

Exercise; Occupational Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: September 15, 2025
• Study Start: May 26, 2023
• Primary Completion: July 2, 2023
• Study Completion: August 2, 2023
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)