NCT05449977

Brief Summary

The aim of this study is to evaluate schizophrenic patients who benefit from community mental health center services in terms of physical activity, physical fitness, and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

July 6, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

1 month

First QC Date

July 4, 2022

Last Update Submit

June 30, 2023

Conditions

Keywords

SchizophreniaPhysical ActivityPhysical fitnessQuality of life

Outcome Measures

Primary Outcomes (2)

  • 2 minutes walk test

    The American Thoracic Society developed the 2-Minute Walk Test and was officially introduced in 2002 with comprehensive guidelines. The 2-Minute Walk Test measures a person's ability to walk in 2 minutes and their functional capacity (13). In this test, the person walks as fast as possible and without assistance, and then the distance the person walks in 2 minutes is measured. The reliability and validity of the 2 Minute Walk Test (in patients with psychological disorders) was proven in 2019 by Davy Vancampfort et al.

    Up to 6 months

  • International Physical Activity Questionnaire-Short Form

    The International Physical Activity Questionnaire was developed by the international consensus group in 1998. It is used to evaluate the physical activity level of the person, taking into account the last 7 days. Considering the level of physical activity in the IPAQ Short Form, the individual was asked for three specific activity types (walking-moderate and vigorous activity) for the last 7 days. It is also a cost effective method. The reliability and validity of the International Short Form of Physical Activity Questionnaire (IPAQ-SF) was proven by Paul H Lee et al. in 2011 (16).

    Up to 6 months

Study Arms (1)

Patients with Schizophrenia

20 patients with schizophrenia will be conducted

Diagnostic Test: Diagnose

Interventions

DiagnoseDIAGNOSTIC_TEST

First, the participants will be asked to fill out a structured questionnaire containing their sociodemographic characteristics. Then, the 2-minute walk test, the International physical activity questionnaire, the SF-36 short form, and the World health organization quality of life questionnaire will be applied respectively.

Patients with Schizophrenia

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

It is planned to include 20 healthy individuals diagnosed with schizophrenia and 20 healthy individuals in the study.

You may qualify if:

  • Individuals diagnosed with schizophrenia by a physician according to DSM-5 criteria
  • Patients treated at CMHC
  • Individuals with schizophrenia who are 18 years or older
  • Patients without other comorbid psychiatric disorders
  • Patients who can communicate and collaborate
  • Patients who agreed to participate in this study and gave informed consent

You may not qualify if:

  • Those who did not give consent to participate in the study
  • Patients with a diagnosis other than schizophrenia
  • Pregnancy
  • Patients with chronic metabolic diseases such as diabetes, heart problems and cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ebru Akbuğa Koç

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SchizophreniaMotor Activity

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavior

Study Officials

  • Ebru Akbuğa Koç

    Yeditepe Üniversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 8, 2022

Study Start

July 6, 2022

Primary Completion

August 6, 2022

Study Completion

August 15, 2022

Last Updated

July 3, 2023

Record last verified: 2023-06

Locations