Alcohol Abuse/DependenceNCT06850428
Examining the Relationship Between Physical Activity Levels and Chronotype Tendencies in Individuals With Alcohol Dependence
An observational study of Alcohol Abuse/Dependence, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
Alcohol use disorders are characterized by excessive alcohol consumption and loss of control and are associated with high mortality and disease burden. The relationship between physical activity and alcoholism is complex, and low physical activity has been shown to be linked to alcohol consumption. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Abuse/Dependence
- How many people
- 207 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 15 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: 207
Who may be able to join
- Age: Being between 18-65 years old.
- Alcohol Dependence: Having alcohol dependence and this condition being confirmed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria or stated based on self-report.
- Remission Status: Being in remission for at least 1 month (i.e., no active alcohol use).
Who cannot join
- Active Psychiatric Diseases: For example, individuals with active psychiatric diseases such as schizophrenia or bipolar disorder will not be included in the study.
- Physical Disability: Individuals with any physical disability will also be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences Gülhane Faculty of Physiotherapy and Rehabilitation
Ankara, Keçiören, 06000
Özge ÖZKUTLU, Assistant Professor, +90 5301362961, ozge.coban@sbu.edu.tr
About this study
Alcohol use disorders are characterized by excessive alcohol consumption and loss of control and are associated with high mortality and disease burden. The relationship between physical activity and alcoholism is complex, and low physical activity has been shown to be linked to alcohol consumption. Additionally, individuals' circadian rhythms (chronotypes) may influence alcohol consumption habits; Evening-type individuals are more likely to consume alcohol. This study aims to examine the relationship between physical activity levels and chronotype trends in individuals with alcohol addiction.
Read the detailed description
This study aims to examine the relationship between physical activity levels and chronotype tendencies in individuals with alcohol dependency. Alcohol use disorders are characterized by excessive alcohol consumption and loss of control, and are associated with high mortality rates and disease burden. The relationship between physical activity and alcoholism is complex, with connections found between low physical activity levels and increased alcohol consumption. Additionally, individuals' circadian rhythms (chronotypes) can influence alcohol consumption habits, and evening-type individuals may be more likely to consume alcohol.
Participants and Method The study will include individuals aged 18-65, diagnosed with alcohol dependency according to DSM-5 criteria, and who have been in remission for at least one month. Individuals with active psychiatric disorders or physical disabilities will be excluded from the study. The sample size was determined using G*Power analysis, with a target of 207 participants for the ANOVA test. Participants will be reached through social media, support groups, rehabilitation centers, and health professionals, and assessments will be conducted via Google Forms. Participants will provide informed consent prior to participation. The sampling method is non-probability sampling.
Assessment Tools Chronotype Evaluation: The participants' circadian rhythms will be assessed using the "Morningness-Eveningness Questionnaire" in Turkish, which has proven validity and reliability. This scale consists of 19 items used to determine whether individuals have a morning, evening, or intermediate chronotype. Total scores will be categorized into five different chronotype groups based on predetermined ranges.
Physical Activity Level Evaluation The "International Physical Activity Questionnaire - Short Form," with proven validity in Turkish, will be used. This questionnaire measures walking, moderate, and vigorous physical activities and determines the total physical activity level in MET-minutes.
This research aims to contribute to a better understanding of the relationship between physical activity and chronotype in individuals with alcohol dependency. This study is designed as a cross-sectional observational research.
- Conditions
- Alcohol Abuse/Dependence
- Keywords
- chronotype, Alcohol abuse/Dependence, physical activity, physical activity level
- Medical subject headings
- Alcoholism, Motor Activity
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 |
|---|---|---|
| Evening Type | This group includes individuals who are most productive in the evening. They prefer to stay awake until late in the evening and have difficulty getting up in the morning. They reach their highest energy levels and efficiency in the evening hours. | |
| Intermediate Type | This group is located between morning and evening types and includes individuals who can be productive at any time of the day. They neither have difficulty waking up early in the morning nor staying awake until late hours. They have a balanced energy level throughout the day. | |
| Morning type | This group includes individuals who have their highest energy levels in the morning hours. They wake up early in the morning and are most productive mentally and physically in the early hours of the day. It is generally preferred to start activities in the morning and sleep early. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between physical activity levels and chronotype trends
The main goal of the study is to determine the relationship between the participants' chronotypes (close to morning, intermediate type, close to evening type) and their physical activity levels in individuals with alcohol addiction.
Measured: from April 2025 to June 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start15 Apr 2025 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Abuse/DependenceStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Çoban, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850428
- Sponsor's protocol ID
- 2025-116
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Relationship Between Physical Activity Levels and Chronotype Tendencies in Individuals With Alcohol Dependence
- ClinicalTrials.gov ID
- NCT06850428
- Acronym / sponsor ID
- 2025-116
- Conditions
- Alcohol Abuse/Dependence
- Keywords
- chronotype, Alcohol abuse/Dependence, physical activity, physical activity level
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 27 Feb 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.
Alcohol use disorders are characterized by excessive alcohol consumption and loss of control and are associated with high mortality and disease burden. The relationship between physical activity and alcoholism is complex, and low physical activity has been shown to be linked to alcohol consumption. Additionally, individuals' circadian rhythms (chronotypes) may influence alcohol consumption habits; Evening-type individuals are more likely to consume alcohol. This study aims to examine the relationship between physical activity levels and chronotype trends in individuals with alcohol addiction.
Detailed description
This study aims to examine the relationship between physical activity levels and chronotype tendencies in individuals with alcohol dependency. Alcohol use disorders are characterized by excessive alcohol consumption and loss of control, and are associated with high mortality rates and disease burden. The relationship between physical activity and alcoholism is complex, with connections found between low physical activity levels and increased alcohol consumption. Additionally, individuals' circadian rhythms (chronotypes) can influence alcohol consumption habits, and evening-type individuals may be more likely to consume alcohol.
Participants and Method The study will include individuals aged 18-65, diagnosed with alcohol dependency according to DSM-5 criteria, and who have been in remission for at least one month. Individuals with active psychiatric disorders or physical disabilities will be excluded from the study. The sample size was determined using G*Power analysis, with a target of 207 participants for the ANOVA test. Participants will be reached through social media, support groups, rehabilitation centers, and health professionals, and assessments will be conducted via Google Forms. Participants will provide informed consent prior to participation. The sampling method is non-probability sampling.
Assessment Tools Chronotype Evaluation: The participants' circadian rhythms will be assessed using the "Morningness-Eveningness Questionnaire" in Turkish, which has proven validity and reliability. This scale consists of 19 items used to determine whether individuals have a morning, evening, or intermediate chronotype. Total scores will be categorized into five different chronotype groups based on predetermined ranges.
Physical Activity Level Evaluation The "International Physical Activity Questionnaire - Short Form," with proven validity in Turkish, will be used. This questionnaire measures walking, moderate, and vigorous physical activities and determines the total physical activity level in MET-minutes.
This research aims to contribute to a better understanding of the relationship between physical activity and chronotype in individuals with alcohol dependency. This study is designed as a cross-sectional observational research.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Evening Type | – | –This group includes individuals who are most productive in the evening. They prefer to stay awake until late in the evening and have difficulty getting up in the morning. They reach their highest energy levels and efficiency in the evening hours. |
| Intermediate Type | – | –This group is located between morning and evening types and includes individuals who can be productive at any time of the day. They neither have difficulty waking up early in the morning nor staying awake until late hours. They have a balanced energy level throughout the day. |
| Morning type | – | –This group includes individuals who have their highest energy levels in the morning hours. They wake up early in the morning and are most productive mentally and physically in the early hours of the day. It is generally preferred to start activities in the morning and sleep early. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 207
Key inclusion criteria (3 listed)
- Age: Being between 18-65 years old.
- Alcohol Dependence: Having alcohol dependence and this condition being confirmed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria or stated based on self-report.
- Remission Status: Being in remission for at least 1 month (i.e., no active alcohol use).
Key exclusion criteria (2 listed)
- Active Psychiatric Diseases: For example, individuals with active psychiatric diseases such as schizophrenia or bipolar disorder will not be included in the study.
- Physical Disability: Individuals with any physical disability will also be excluded from 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
Relationship between physical activity levels and chronotype trends
Time frame: from April 2025 to June 2025
The main goal of the study is to determine the relationship between the participants' chronotypes (close to morning, intermediate type, close to evening type) and their physical activity levels in individuals with alcohol addiction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
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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.
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 Alcohol Abuse/Dependence, run by Gulhane School of Medicine 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Özge Özkutlu, Assistant Professor (+90 5301362961, ozge.coban@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between physical activity levels and chronotype trends (time frame: from April 2025 to June 2025). 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 27 Feb 2025.