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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05936983
Other study ID # 2023/514/247/4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2, 2023
Est. completion date June 20, 2023

Study information

Verified date June 2023
Source Yeditepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

According to the World Health Organization; Bipolar disorder ranks in the top 20 causes of disability among all medical conditions and 6th among mental disorders worldwide. Bipolar disorder is noted as a serious mental illness involving emotional ups and downs.


Description:

Schizophrenia is a chronic mental disorder characterized by the appearance of both positive symptoms such as hallucinations and delusions and negative symptoms such as apathy and withdrawal, repetition of cognitive skills, and disorganization. In this study, it was aimed to compare physical fitness, physical activity level, depression and quality of life in bipolar disoder and schizophrenic patients with healthy individuals.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date June 20, 2023
Est. primary completion date June 15, 2023
Accepts healthy volunteers
Gender All
Age group 30 Years to 55 Years
Eligibility Inclusion Criteria: - Individuals diagnosed with bipolar disorder and schizophrenia by a physician according to DSM-5 criteria - Individuals with bipolar and schizophrenia between the ages of 30-55 - Patients without any other accompanying psychiatric disorder - Patients who can communicate - Patients who agreed to participate in this study and gave informed consent Exclusion Criteria: - Patients with a psychiatric diagnosis other than bipolar and schizophrenia. - Pregnancy condition - Those who did not consent to participate in the study

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Yeditepe University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Waist measurement - Antropometric Measurements Waist measurement is measured from the narrowest area between the subcostal region and the iliac crest. 4 weeks
Primary Abdomen measurement - Antropometric Measurements Abdomen measurement is measured at the level of the umbilicus without compression of the tissues. 4 weeks
Primary The hip measurement - Antropometric Measurements The hip measurement is measured from the thickest part of the hip area. 4 weeks
Primary Eurofit Test Battery A test-retest design was applied to test the reproducibility of several Eurofit test battery items. Supervision and measurement of the Eurofit test battery was performed by one trained mental health physical therapist following a standardized procedure. The Eurofit test battery included seven items and involved the assessment of the following measures: whole body balance, speed of limb movement, flexibility, explosive strength, static strength, abdominal muscular endurance and running speed. 4 weeks
Primary Quick Inventory of Depressive Symptomatology (QIDS-SR16) scale QIDS-SR consists of 16 items each ranging from 0 to 3. It is scored by summing the highest response in each of a set of questions relating to sleep, weight and psychomotor symptoms and then adding the remaining items 4 weeks
Primary International Physical Activity Questionnaire The IPAQ questionnaires list activities and request estimates of durations and frequencies for each activity engaged in over the past week. Durations are multiplied by known METs per activity and the results for all items are summed for the overall physical activity score. Scores for walking and for moderate and vigorous activities are sums of corresponding item scores. A sitting question is not included in physical activity score. 4 weeks
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