- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05783674
The Effect of Brain Breaks on People With Mental Health Problems
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: HABİBE SERAP S İNAL, PHD, PT
- Phone Number: 05325573354
- Email: srpl.oan@gmail.com
Study Contact Backup
- Name: ÖZGE ECEM E ŞENEL, MSC, PT
- Phone Number: 05392642868
- Email: vinaricecem@hotmail.com
Study Locations
-
-
Zeytinburnu
-
Istanbul, Zeytinburnu, Turkey, 34010
- Recruiting
- Istinye University
-
Contact:
- YASEMİN BURAN, PHD, PT
- Phone Number: +905443759723
- Email: ycirak@istinye.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Having a serious chronic illness,
- It is a notification that physical activity and exercise are not appropriate due to a serious mental illness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BrainBreaks for people without mental health problems
|
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.
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.
|
|
Experimental: BrainBreaks for people with mental health problems
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 weeks
|
|
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).
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6 minutes walking test
Time Frame: 12 weeks
|
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.
|
12 weeks
|
|
Visual Pain Scale
Time Frame: 12 weeks
|
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.
|
12 weeks
|
|
New York Posture Assessment Test
Time Frame: 12 weeks
|
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.
|
12 weeks
|
|
268 / 5.000 Çeviri sonuçları Çeviri sonucu Muscle Elasticity
Time Frame: 12 weeks
|
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.
|
12 weeks
|
|
Muscle Strength
Time Frame: 12 weeks
|
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.
|
12 weeks
|
|
Body Mass Index
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2239 (Fred Hutch/University of Washington Cancer Consortium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Physical Inactivity
-
Bess MarcusNational Heart, Lung, and Blood Institute (NHLBI); Lifespan/ The Miriam HospitalRecruitingInactivity | Inactivity, Physical | Inactivity/Low Levels of ExerciseUnited States
-
Chinese University of Hong KongNot yet recruitingPhysical InactivityHong Kong
-
Brown UniversityNational Cancer Institute (NCI)Recruiting
-
University of Milano BicoccaFederico II University; University of BergamoRecruitingPhysical InactivityItaly
-
University of CalgaryPublic Health Agency of Canada (PHAC)Recruiting
-
University of MinnesotaCompletedPhysical InactivityUnited States
-
Universiti Putra MalaysiaCompletedInactivity, PhysicalPakistan
-
Ludwig Boltzmann Institute for Digital Health and...CompletedPhysical InactivityAustria
-
Brown UniversityNational Institute of General Medical Sciences (NIGMS)CompletedPhysical InactivityUnited States
-
Clemson UniversityPrisma Health-Upstate; YMCACompleted
Clinical Trials on Brain Breaks® Video Exercises
-
Anhui Medical UniversityCompletedPostural Balance | Dynamic BalanceChina
-
University of PaviaNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisRecruitingAxial SpondyloarthritisFrance
-
Sanko UniversityRecruitingSleep Quality | Physical Fitness | Open Heart SurgeryTurkey
-
Fenerbahce UniversityCompletedExercise | ElderlyTurkey
-
Atlas UniversityCompleted
-
Bartın UnıversityCompletedPulmonary Disease, Chronic ObstructiveTurkey (Türkiye)
-
Izmir Democracy UniversityCompleted
-
Aliaa Altohamy GodaCompleted