Bipolar Disorder (BD)NCT07140042
Physical Fitness, Physical Activity Level, Depression and Quality of Life in Bipolar and Schizophrenia Patients
An observational study of Bipolar Disorder (BD) and Schizophrenia Disorder, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Assessment of physical activity levels, physical fitness and quality of life of bipolar and schizophrenia patients is necessary to verify the effectiveness of treatments and care activities in Community Mental Health Centers (CMHCs) and to plan new therapeutic and rehabilitative activities. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder (BD), Schizophrenia Disorder
- What is being tested?
- Survey
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2025to 12 Aug 2025
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: bipolar and schizophrenia
Who may be able to join
- - Individuals diagnosed with bipolar and schizophrenia by a physician according to DSM-5 criteria
- Individuals with bipolar and schizophrenia between the ages of 18-64
- Patients without other concomitant psychiatric disorders
- 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 Not giving 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 Bipolar and Schizophrenia Patients With Healthy Controls
Assessment of physical activity levels, physical fitness and quality of life of bipolar and schizophrenia patients is necessary to verify the effectiveness of treatments and care activities in Community Mental Health Centers (CMHCs) and to plan new therapeutic and rehabilitative activities. In one study, they found that physical activity level-physical fitness has a positive impact on psychiatric services and can improve physical health outcomes of patients with schizophrenia. They also found an improvement in psychological and social outcomes in these patients. Therefore, physical activity level and physical fitness are stated as critical parameters of biopsychosocial approach in mental health services.
The aim of this study was to compare physical fitness, physical activity level, depression and quality of life in bipolar and schizophrenia patients with healthy individuals.
Read the detailed description
Bipolar disorder ranks among the top 20 causes of disability among all medical conditions worldwide and 6th among mental disorders. Bipolar disorder is defined as a serious mental illness involving emotional ups and downs. It is a disorder characterized by two distinct periods of illness, manic and depressive . These two periods of illness are characterized by remission and exacerbation. The patient completely returns to normal except for the periods of illness. The mania or outburst period is when the mood is very high. Bipolar patients have a reduced life expectancy and a higher risk of developing metabolic syndromes. It is a serious mental health problem in terms of mortality, morbidity and suicide . Bipolar individuals have a higher mortality and morbidity rate than the general population. Exercise and physical activity are highly effective in preventing mortality and cardiovascular diseases and can reduce the risk of cardiovascular disease. The International Organization of Physiotherapists recommends that individuals with mental illness should do at least 150 minutes of brisk walking or 75 minutes of physical activity per week.
Exercise is also an effective method in the treatment of mood disorders in patients with bipolar disorder. Aerobic physical exercises are also a good treatment for neurocognitive dysfunction in patients with bipolar disorder. Decreased walking capacity in hospitalized patients with bipolar disorder is due to impaired muscle conditioning, which affects daily living functions. At the same time, bipolar individuals have poorer exercise habits such as less walking and less strength exercises than healthy individuals. A qualitative study in bipolar patients also found that mood influences physical activity. Schizophrenia is a chronic mental disorder characterized by the occurrence of both positive symptoms such as hallucinations and delusions and negative symptoms such as apathy and withdrawal, repetition of cognitive skills and disorganization. Patients with schizophrenia have been found to be less physically active and less physically fit than the general population. Exercise is a subset of physical activity that is planned, structured and repetitive bodily movements performed to increase and maintain one or more parts of physical fitness.
Therefore, physical activity level and physical fitness are stated as critical parameters of biopsychosocial approach in mental health services.
The aim of this study was to compare physical fitness, physical activity level, depression and quality of life in bipolar and schizophrenia patients with healthy individuals.
- Conditions
- Bipolar Disorder (BD), Schizophrenia Disorder
- Being tested
- Survey
- 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.
SurveyOther
Survey
| Study group | Role | What they receive |
|---|---|---|
| Bipolar group | Bipolar disorder Receives: Other: Survey | |
| schizophrenia group | schizophrenia disorder Receives: Other: Survey | |
| healthy control group | healthy control Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antropometric measurement
Antropometric measurement will be evaluated like weight, height, body mass index, circumferences etc.
Measured: 2 week
International Physical Activity Questionnaire
To measure Physical Activity Level
Measured: 2 weeks
Beck Depression Inventory
Depression
Measured: 2 weeks
Short form 36
Quality of life
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start23 Jun 2025
- Primary completion5 Aug 2025
- Study completion12 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder (BD)Studies 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
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İsmail Koç, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140042
- Sponsor's protocol ID
- IKoc
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 24 Aug 2025
- 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 24 Aug 2025. 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 Bipolar and Schizophrenia Patients With Healthy Controls
- ClinicalTrials.gov ID
- NCT07140042
- Acronym / sponsor ID
- IKoc
- Conditions
- Bipolar Disorder (BD), Schizophrenia Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 12 Aug 2025 (actual)
- First posted
- 24 Aug 2025 (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.
Assessment of physical activity levels, physical fitness and quality of life of bipolar and schizophrenia patients is necessary to verify the effectiveness of treatments and care activities in Community Mental Health Centers (CMHCs) and to plan new therapeutic and rehabilitative activities. In one study, they found that physical activity level-physical fitness has a positive impact on psychiatric services and can improve physical health outcomes of patients with schizophrenia. They also found an improvement in psychological and social outcomes in these patients. Therefore, physical activity level and physical fitness are stated as critical parameters of biopsychosocial approach in mental health services.
The aim of this study was to compare physical fitness, physical activity level, depression and quality of life in bipolar and schizophrenia patients with healthy individuals.
Detailed description
Bipolar disorder ranks among the top 20 causes of disability among all medical conditions worldwide and 6th among mental disorders. Bipolar disorder is defined as a serious mental illness involving emotional ups and downs. It is a disorder characterized by two distinct periods of illness, manic and depressive . These two periods of illness are characterized by remission and exacerbation. The patient completely returns to normal except for the periods of illness. The mania or outburst period is when the mood is very high. Bipolar patients have a reduced life expectancy and a higher risk of developing metabolic syndromes. It is a serious mental health problem in terms of mortality, morbidity and suicide . Bipolar individuals have a higher mortality and morbidity rate than the general population. Exercise and physical activity are highly effective in preventing mortality and cardiovascular diseases and can reduce the risk of cardiovascular disease. The International Organization of Physiotherapists recommends that individuals with mental illness should do at least 150 minutes of brisk walking or 75 minutes of physical activity per week.
Exercise is also an effective method in the treatment of mood disorders in patients with bipolar disorder. Aerobic physical exercises are also a good treatment for neurocognitive dysfunction in patients with bipolar disorder. Decreased walking capacity in hospitalized patients with bipolar disorder is due to impaired muscle conditioning, which affects daily living functions. At the same time, bipolar individuals have poorer exercise habits such as less walking and less strength exercises than healthy individuals. A qualitative study in bipolar patients also found that mood influences physical activity. Schizophrenia is a chronic mental disorder characterized by the occurrence of both positive symptoms such as hallucinations and delusions and negative symptoms such as apathy and withdrawal, repetition of cognitive skills and disorganization. Patients with schizophrenia have been found to be less physically active and less physically fit than the general population. Exercise is a subset of physical activity that is planned, structured and repetitive bodily movements performed to increase and maintain one or more parts of physical fitness.
Therefore, physical activity level and physical fitness are stated as critical parameters of biopsychosocial approach in mental health services.
The aim of this study was to compare physical fitness, physical activity level, depression and quality of life in bipolar and schizophrenia patients with healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bipolar group | – | Other: SurveyBipolar disorder |
| schizophrenia group | – | Other: Surveyschizophrenia disorder |
| healthy control group | – | Other: Surveyhealthy control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- bipolar and schizophrenia
Key inclusion criteria (5 listed)
- - Individuals diagnosed with bipolar and schizophrenia by a physician according to DSM-5 criteria
- Individuals with bipolar and schizophrenia between the ages of 18-64
- Patients without other concomitant psychiatric disorders
- Patients who can communicate
- Patients who agreed to participate in this study and gave informed consent
Key exclusion criteria (1 listed)
- - Patients with a psychiatric diagnosis other than bipolar and schizophrenia. Pregnancy Not giving 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveySurvey | Other | Bipolar group, healthy control group, schizophrenia group |
Primary outcome
Antropometric measurement
Time frame: 2 week
Antropometric measurement will be evaluated like weight, height, body mass index, circumferences etc.
International Physical Activity Questionnaire
Time frame: 2 weeks
To measure Physical Activity Level
Beck Depression Inventory
Time frame: 2 weeks
Depression
Short form 36
Time frame: 2 weeks
Quality of life
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 24 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Bipolar Disorder (BD)
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
Active, not recruiting
Functional Remediation for Older Adults With Bipolar Disorder
Bipolar Disorder
Enrolling by invitation
Incentives and Long-Acting Injectable Adherence After Involuntary Hospitalization
Schizophrenia Disorder, Schizoaffective Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
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 (BD) and Schizophrenia Disorder, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital 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 1 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 24 Aug 2025. 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?
Antropometric measurement (time frame: 2 week). The study lists 4 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 24 Aug 2025.