Physical InactivityNCT05783674
The Effect of Brain Breaks on People With Mental Health Problems
A study testing Brain Breaks® Video Exercises and Posture training in people with Physical Inactivity, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Regular physical activity (PA) and adopting an active lifestyle protect against non-communicable diseases such as diabetes, cardiovascular diseases, hypertension, obesity, and colon cancer in the general population. However, the habit of doing regular FA in societies is quite low. Read more about this study
- Who is it for?
- Ages 25 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Brain Breaks® Video Exercises and Posture training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2023to 3 Jun 2023
- Phase
- Interventional
- 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 25 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be diagnosed with one of the mental health problems,
- Being over 25 years old and male,
- T.C. Being a resident of Istanbul Governorship Beylikdüzü Disabled Life Care, Rehabilitation and Family Counseling Center or Carnation Care Center located in Kemerburgaz Büyükçekmece,
- To volunteer to participate in the study
Who cannot join
- Having a serious chronic illness,
- It is a notification that physical activity and exercise are not appropriate due to a serious mental illness.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istinye University
Istanbul, Zeytinburnu, 34010
YASEMİN BURAN, PHD, PT, +905443759723, ycirak@istinye.edu.tr
About this study
Official title: The Effect of Physical Activity and Exercise by Brain Breaks®️ Video Games on Sleep and Life Quality of People With Mental Health Problems
Regular physical activity (PA) and adopting an active lifestyle protect against non-communicable diseases such as diabetes, cardiovascular diseases, hypertension, obesity, and colon cancer in the general population. However, the habit of doing regular FA in societies is quite low. It is reported that those adopting a sedentary lifestyle in the general population range from 16.3% to 39.1%, with an average of 27.5%. These values indicate that the risk of contracting non-communicable diseases can be reduced by developing the habit of doing FA for almost one-third of the population. Based on this idea, the World Health Organization has decided to increase FA by 10% among the "Nine Global Goals" it has addressed against the spread of non-communicable diseases.
People with mental health problems are less active than the general population. For example, it is reported that people diagnosed with major depression syndrome are 50% less active than their peers. Dikerson et al. reported that people with mental illnesses are 50% more obese than their peers. Verhoeven et al. They concluded that people with severe and chronic depression will age biologically earlier (7-10 years) than their peers. They emphasized the importance of lifestyle changes in the prevention of biological aging and possible diseases (coronary diseases, type-2 diabetes, obesity, dementia, cancer).
Marquez et al. also indicate that there is a significant relationship between mental illnesses and chronic medical problems such as cancer, cardiovascular diseases, diabetes, and obesity. Therefore, increasing the habit of regular PA and exercise among people with mental health problems is important in protecting against diseases. Our study aims to adopt the habit of doing physical activity accompanied by technology-supported GCH Brain Breaks®️ videos applied to people with mental health problems; In this context, at least 20 minutes of video-accompanied FA and exercise and 30 minutes of exercise in individuals every day to gain the habit of walking.
Read the detailed description
The fact that the group addressed by our study is unique and that these entertaining video exercises have not been previously applied to adults and people with mental health problems makes our study unique. At the same time, we believe that the level of physical activity increased by technology-supported HOPSports Brain Breaks® videos applied to people with mental health problems will improve sleep quality, general physical condition, and life satisfaction of people. This result, which we plan to reach, also increases the originality of our study. Therefore, it is expected that the functional and social results of our technology-assisted FA and exercise program, which will be given to people with mental problems, will contribute to the national and international literature.
Therefore, our study aims to adopt the habit of doing physical activity accompanied by technology-supported GCH Brain Breaks®️ videos applied to people with mental health problems; In this context, at least 20 minutes of video-accompanied FA and exercise and 30 minutes of exercise in individuals every day. to gain the habit of walking.
- Conditions
- Physical Inactivity
- Being tested
- Brain Breaks® Video Exercises, Posture training
- Keywords
- Mental Health Problems, BrainBreaks, Sleep Quality, Quality of Health
- Medical subject headings
- Sedentary Behavior, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Breaks® Video ExercisesOther
A total of at least 140 Brain Breaks® videos, each 3-4 minutes long, aerobic exercises including wide joint movements, movements specific to different sports branches such as yoga and volleyball, basketball, football, tennis, karate, judo, and warm-up-cooling movements. It includes national dances of different cultures. Horon, Zeybek, Scarf dance, morning gymnastics in Ürgüp Göreme, dribbling (volleyball, basketball), Pilates ball, and core area exercises. In each session, 2 videos will be applied and each will be repeated 2-3 times, and a 3-minute rest break will be given between each video. The total session will last for 20-30 minutes on average and physical activity will be performed twice a week, for a total of 8 weeks, 16 sessions.
Posture trainingOther
All participants, as the BB Video Exercise and Control Group, will be given a 20-minute hands-on training on the importance of proper posture once at the beginning of the study, and breathing control training will be given to maintain proper sitting, standing, lying postures, and proper posture.
| Study group | Role | What they receive |
|---|---|---|
| BrainBreaks for people without mental health problems | Experimental | BrainBreaks for people without mental health problems Receives: Other: Brain Breaks® Video Exercises; Other: Posture training |
| BrainBreaks for people with mental health problems | Experimental | BrainBreaks for people with mental health problems Receives: Other: Brain Breaks® Video Exercises; Other: Posture training |
What is being measured
The primary outcome is the main question the study is designed to answer.
pittsburgh sleep quality index
Sleep quality will be evaluated with the Pittsburg Sleep Quality Index (PUKI), developed by Buysse et al. (1989) and adapted into Turkish by Ağargün et al. (1996). PUKI is a 19-item self-report scale that evaluates sleep quality and disturbance in the past month. It consists of 24 questions, 19 questions are self-report questions, and 5 questions are questions to be answered by the spouse or roommate.
Measured: 12 weeks
Contentment with Life Scale
The Content with Life Scale, consisting of 5 items, developed by Lavallee et al. (2007) will be used to evaluate life satisfaction. This one-dimensional scale has a 7-point Likert-type rating ("1" strongly disagree- "7" strongly agree).
Measured: 12 weeks
Secondary outcomes (6)
6 minutes walking test
The six-minute walk test (6 MWT) is the most commonly used submaximal exercise test in clinical practice. In a long corridor (30 meters), the patient is asked to walk at normal walking speed for 6 minutes. The time will be measured with a stopwatch. It is calculated how many meters the patient has traveled after the test.
Measured: 12 weeks
Visual Pain Scale
It is a frequently used evaluation method to convert the severity of pain that cannot be measured numerically into numerical data. Above a 100mm line, the person marks where he or she describes his condition. The far left of the line is defined as "I have no pain" and the far right is defined as "I have very severe pain". Data is obtained by measuring the distance between the place marked by the patient and the place where he has no pain.
Measured: 12 weeks
New York Posture Assessment Test
Postures of individuals were determined by the New York Posture Assessment Test, thirteen (13) regions of the body from the back (head-A, shoulder levels-B, vertebral column-C, hip levels-D, mediolateral position of the feet-E, foot arches-F) and side ( head-G, rib cage-H, shoulders-I, upper back-J, trunk-K, abdomen-L, lower back-waist-M) will be observed and scored on the form.
Measured: 12 weeks
268 / 5.000 Çeviri sonuçları Çeviri sonucu Muscle Elasticity
Shortness-Flexibility assessment Hamstrings, Lumbal extensors, Pectorals, Tensor Fascia Latae, and Gastrocnemius muscles (short:3, moderately short:2, and normal:1) will be evaluated. Measurements will be made separately for the right and left sides of the body.
Measured: 12 weeks
Muscle Strength
As peripheral muscle strength, quadriceps femoris, tibialis anterior, tibialis posterior, extensor hallucis, flexor hallucis, gastrocnemius, soleus, hamstring gluteus maximus, gluteus medius, back extensor muscles, abdominal muscles strength, portable manual muscle strength measuring device myometer (Model 01165, IN, USA) in kg. Measurements for the right and left sides will be repeated three times and the best value obtained will be recorded in Newtons (N). Measurements 15 min. is expected to last.
Measured: 12 weeks
Body Mass Index
The main variables to be used as a reference in anthropometric evaluations, body mass index, were preferred especially because it is an easy and fast measurement method in the clinic and a primary obesity assessment tool for adults. BMI data of individuals will be calculated by dividing the body weight in kilograms by the square of the height in meters.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start5 Mar 2023
- Primary completion3 May 2023 (estimated)
- Study completion3 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783674
- Sponsor's protocol ID
- 2239
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 24 Mar 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 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Activity and Exercise by Brain Breaks®️ Video Games on Sleep and Life Quality of People With Mental Health Problems
- ClinicalTrials.gov ID
- NCT05783674
- Acronym / sponsor ID
- 2239
- Conditions
- Physical Inactivity
- Keywords
- Mental Health Problems, BrainBreaks, Sleep Quality, Quality of Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 3 May 2023 (estimated)
- Study completion
- 3 Jun 2023 (estimated)
- First posted
- 24 Mar 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.
Regular physical activity (PA) and adopting an active lifestyle protect against non-communicable diseases such as diabetes, cardiovascular diseases, hypertension, obesity, and colon cancer in the general population. However, the habit of doing regular FA in societies is quite low. It is reported that those adopting a sedentary lifestyle in the general population range from 16.3% to 39.1%, with an average of 27.5%. These values indicate that the risk of contracting non-communicable diseases can be reduced by developing the habit of doing FA for almost one-third of the population. Based on this idea, the World Health Organization has decided to increase FA by 10% among the "Nine Global Goals" it has addressed against the spread of non-communicable diseases.
People with mental health problems are less active than the general population. For example, it is reported that people diagnosed with major depression syndrome are 50% less active than their peers. Dikerson et al. reported that people with mental illnesses are 50% more obese than their peers. Verhoeven et al. They concluded that people with severe and chronic depression will age biologically earlier (7-10 years) than their peers. They emphasized the importance of lifestyle changes in the prevention of biological aging and possible diseases (coronary diseases, type-2 diabetes, obesity, dementia, cancer).
Marquez et al. also indicate that there is a significant relationship between mental illnesses and chronic medical problems such as cancer, cardiovascular diseases, diabetes, and obesity. Therefore, increasing the habit of regular PA and exercise among people with mental health problems is important in protecting against diseases. Our study aims to adopt the habit of doing physical activity accompanied by technology-supported GCH Brain Breaks®️ videos applied to people with mental health problems; In this context, at least 20 minutes of video-accompanied FA and exercise and 30 minutes of exercise in individuals every day to gain the habit of walking.
Detailed description
The fact that the group addressed by our study is unique and that these entertaining video exercises have not been previously applied to adults and people with mental health problems makes our study unique. At the same time, we believe that the level of physical activity increased by technology-supported HOPSports Brain Breaks® videos applied to people with mental health problems will improve sleep quality, general physical condition, and life satisfaction of people. This result, which we plan to reach, also increases the originality of our study. Therefore, it is expected that the functional and social results of our technology-assisted FA and exercise program, which will be given to people with mental problems, will contribute to the national and international literature.
Therefore, our study aims to adopt the habit of doing physical activity accompanied by technology-supported GCH Brain Breaks®️ videos applied to people with mental health problems; In this context, at least 20 minutes of video-accompanied FA and exercise and 30 minutes of exercise in individuals every day. to gain the habit of walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BrainBreaks for people without mental health problems | Experimental | Other: Brain Breaks® Video Exercises, Other: Posture trainingBrainBreaks for people without mental health problems |
| BrainBreaks for people with mental health problems | Experimental | Other: Brain Breaks® Video Exercises, Other: Posture trainingBrainBreaks for people with mental health problems |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be diagnosed with one of the mental health problems,
- Being over 25 years old and male,
- T.C. Being a resident of Istanbul Governorship Beylikdüzü Disabled Life Care, Rehabilitation and Family Counseling Center or Carnation Care Center located in Kemerburgaz Büyükçekmece,
- To volunteer to participate in the study
Key exclusion criteria (2 listed)
- Having a serious chronic illness,
- It is a notification that physical activity and exercise are not appropriate due to a serious mental illness.
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 |
|---|---|---|
| Brain Breaks® Video ExercisesA total of at least 140 Brain Breaks® videos, each 3-4 minutes long, aerobic exercises including wide joint movements, movements specific to different sports branches such as yoga and volleyball, basketball, football, tennis, karate, judo, and warm-up-cooling movements. It includes national dances of different cultures. Horon, Zeybek, Scarf dance, morning gymnastics in Ürgüp Göreme, dribbling (volleyball, basketball), Pilates ball, and core area exercises. In each session, 2 videos will be applied and each will be repeated 2-3 times, and a 3-minute rest break will be given between each video. The total session will last for 20-30 minutes on average and physical activity will be performed twice a week, for a total of 8 weeks, 16 sessions. | Other | BrainBreaks for people with mental health problems, BrainBreaks for people without mental health problems |
| Posture trainingAll participants, as the BB Video Exercise and Control Group, will be given a 20-minute hands-on training on the importance of proper posture once at the beginning of the study, and breathing control training will be given to maintain proper sitting, standing, lying postures, and proper posture. | Other | BrainBreaks for people with mental health problems, BrainBreaks for people without mental health problems |
Primary outcome
pittsburgh sleep quality index
Time frame: 12 weeks
Sleep quality will be evaluated with the Pittsburg Sleep Quality Index (PUKI), developed by Buysse et al. (1989) and adapted into Turkish by Ağargün et al. (1996). PUKI is a 19-item self-report scale that evaluates sleep quality and disturbance in the past month. It consists of 24 questions, 19 questions are self-report questions, and 5 questions are questions to be answered by the spouse or roommate.
Contentment with Life Scale
Time frame: 12 weeks
The Content with Life Scale, consisting of 5 items, developed by Lavallee et al. (2007) will be used to evaluate life satisfaction. This one-dimensional scale has a 7-point Likert-type rating ("1" strongly disagree- "7" strongly agree).
6 secondary outcomes
6 minutes walking test
Time frame: 12 weeks
Visual Pain Scale
Time frame: 12 weeks
New York Posture Assessment Test
Time frame: 12 weeks
268 / 5.000 Çeviri sonuçları Çeviri sonucu Muscle Elasticity
Time frame: 12 weeks
Muscle Strength
Time frame: 12 weeks
Body Mass Index
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Breaks® Video Exercises and Posture training in people with Physical Inactivity, run by Istinye 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 4 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: status not confirmed, as of the sponsor's last update on 24 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HABİBE SERAP S İNAL, PHD, PT (05325573354, srpl.oan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pittsburgh sleep quality index (time frame: 12 weeks). The study lists 2 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 Mar 2023.