Bipolar DisorderNCT05936983
Comparison of Physical Fitness, Physical Activity Level in Patients With Bipolar Disorder and Schizophrenia
An observational study of Bipolar Disorder and Schizophrenia, run by Yeditepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Bipolar Disorder, Schizophrenia
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2023to 20 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Adult
Study population: patients with Bipolar disorder and schizophrenia come to the community mental health center regularly
Who may be able to join
- 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
Who cannot join
- Patients with a psychiatric diagnosis other than bipolar and schizophrenia.
- Pregnancy condition
- Those who did not consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Physical Fitness, Physical Activity Level, Depression and Quality of Life in Patients With Bipolar Disorder and Schizophrenia With Healthy Controls
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.
Read the detailed 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.
- Conditions
- Bipolar Disorder, Schizophrenia
- Medical subject headings
- Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Bipolar disorder | Participants will be asked to fill out a structured questionnaire containing their sociodemographic characteristics. Then, Anthropometric Measurements, Eurofit test battery, Rapid Depressive Symptom Inventory-Self-Report Form and International physical activity questionnaire will be applied respectively. | |
| Patients with Schizophrenia group | Participants will be asked to fill out a structured questionnaire containing their sociodemographic characteristics. Then, Anthropometric Measurements, Eurofit test battery, Rapid Depressive Symptom Inventory-Self-Report Form and International physical activity questionnaire will be applied respectively. | |
| Healthy group | Participants will be asked to fill out a structured questionnaire containing their sociodemographic characteristics. Then, Anthropometric Measurements, Eurofit test battery, Rapid Depressive Symptom Inventory-Self-Report Form and International physical activity questionnaire will be applied respectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist measurement - Antropometric Measurements
Waist measurement is measured from the narrowest area between the subcostal region and the iliac crest.
Measured: 4 weeks
Abdomen measurement - Antropometric Measurements
Abdomen measurement is measured at the level of the umbilicus without compression of the tissues.
Measured: 4 weeks
The hip measurement - Antropometric Measurements
The hip measurement is measured from the thickest part of the hip area.
Measured: 4 weeks
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.
Measured: 4 weeks
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
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start2 Jun 2023
- Primary completion15 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ebru Akbuğa Koç, Principal investigator, Yeditepe Universityİsmail Koç, Principal investigator, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936983
- Sponsor's protocol ID
- 2023/514/247/4
- Status last verified
- Jun 2023
- First submitted
- 31 May 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Physical Fitness, Physical Activity Level, Depression and Quality of Life in Patients With Bipolar Disorder and Schizophrenia With Healthy Controls
- ClinicalTrials.gov ID
- NCT05936983
- Acronym / sponsor ID
- 2023/514/247/4
- Conditions
- Bipolar Disorder, Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Bipolar disorder | – | –Participants will be asked to fill out a structured questionnaire containing their sociodemographic characteristics. Then, Anthropometric Measurements, Eurofit test battery, Rapid Depressive Symptom Inventory-Self-Report Form and International physical activity questionnaire will be applied respectively. |
| Patients with Schizophrenia group | – | –Participants will be asked to fill out a structured questionnaire containing their sociodemographic characteristics. Then, Anthropometric Measurements, Eurofit test battery, Rapid Depressive Symptom Inventory-Self-Report Form and International physical activity questionnaire will be applied respectively. |
| Healthy group | – | –Participants will be asked to fill out a structured questionnaire containing their sociodemographic characteristics. Then, Anthropometric Measurements, Eurofit test battery, Rapid Depressive Symptom Inventory-Self-Report Form and International physical activity questionnaire will be applied respectively. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- patients with Bipolar disorder and schizophrenia come to the community mental health center regularly
Key inclusion criteria (5 listed)
- Individuals diagnosed with bipolar disorder and schizophrenia by a physician according to DSM-5 criteria
Key exclusion criteria (3 listed)
- Patients with a psychiatric diagnosis other than bipolar and schizophrenia.
- Pregnancy condition
- Those who did not consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Waist measurement - Antropometric Measurements
Time frame: 4 weeks
Waist measurement is measured from the narrowest area between the subcostal region and the iliac crest.
Abdomen measurement - Antropometric Measurements
Time frame: 4 weeks
Abdomen measurement is measured at the level of the umbilicus without compression of the tissues.
The hip measurement - Antropometric Measurements
Time frame: 4 weeks
The hip measurement is measured from the thickest part of the hip area.
Eurofit Test Battery
Time frame: 4 weeks
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.
Quick Inventory of Depressive Symptomatology (QIDS-SR16) scale
Time frame: 4 weeks
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
International Physical Activity Questionnaire
Time frame: 4 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru Akbuğa Koç principal investigator
Yeditepe University
İsmail Koç principal investigator
Dr. Lutfi Kirdar Kartal Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Schizophrenia, run by Yeditepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist measurement - Antropometric Measurements (time frame: 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.