NCT07141966

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

August 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

February 11, 2026

Status Verified

August 1, 2025

Enrollment Period

11 days

First QC Date

August 19, 2025

Last Update Submit

February 8, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Positive and Negative Syndrome Scale

    This is a 30-item, 7-point semi-structured interview scale. Of the 30 psychiatric parameters, seven belong to the positive symptoms subscale, seven to the negative symptoms subscale, and 16 to the general psychopathology subscale. The Turkish reliability and validity study of the scale was conducted by Kostakoğlu et al.

    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.

    2 weeks

  • Handgrip Strength

    The Jamar hand dynamometer, recommended by the American Hand Therapy Association (AETD) and widely accepted as the gold standard due to its high validity and reliability in numerous studies, will be used to measure hand grip strength. Hand grip strength will be measured in the standard position recommended by the ATA: sitting position, shoulders in adduction and neutral rotation, elbow at 90° flexion, forearm in mid-rotation and supported, wrist in neutral position. In the test procedure, three measurements will be taken for handgrip strength, with one-minute intervals between each measurement, and the averages will be recorded.

    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.

    2 weeks

  • 30-Second Sit-to-Stand Test

    The individual will be positioned in the center of the chair with their back straight, feet flat on the ground, and arms crossed in front of their chest (right hand on left shoulder, left hand on right shoulder). In this position, the test will begin with the command "start," and the subject will perform as many full stand-ups as possible within 30 seconds. The number of full stand-ups performed within 30 seconds will constitute the subject's score. To ensure the test is performed safely, the back of the chair will be secured against a wall or a sturdy surface. Each participant will be shown how to perform the test, and after ensuring that they understand how to perform the test by having them attempt it 2-3 times, the test will begin.

    2 weeks

  • 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.

    2 weeks

Study Arms (1)

patients with schizophrenia

patients with schizophrenia

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with Schizophrenia

You may qualify if:

  • Diagnosis of schizophrenia by a psychiatrist according to DSM-V
  • Unchanged medication treatment for the last 2 months
  • Being over 18 years of age
  • Individuals must be able to understand and speak Turkish
  • Individuals must be able to read and write

You may not qualify if:

  • Uncontrolled hypertension
  • Surgery within the last 2 months
  • Orthopedic surgery on the lower extremities
  • Cardio-respiratory failure that prevents walking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Dr Lütfi Kırdar City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof

Study Record Dates

First Submitted

August 19, 2025

First Posted

August 26, 2025

Study Start

August 19, 2025

Primary Completion

August 30, 2025

Study Completion

September 15, 2025

Last Updated

February 11, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations