NCT05783674

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2023

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 14, 2023

Last Update Submit

March 14, 2023

Conditions

Keywords

Mental Health ProblemsBrainBreaksSleep QualityQuality of Health

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    12 weeks

Secondary Outcomes (6)

  • 6 minutes walking test

    12 weeks

  • Visual Pain Scale

    12 weeks

  • New York Posture Assessment Test

    12 weeks

  • 268 / 5.000 Çeviri sonuçları Çeviri sonucu Muscle Elasticity

    12 weeks

  • Muscle Strength

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

BrainBreaks for people without mental health problems

EXPERIMENTAL

BrainBreaks for people without mental health problems

Other: Brain Breaks® Video ExercisesOther: Posture training

BrainBreaks for people with mental health problems

EXPERIMENTAL

BrainBreaks for people with mental health problems

Other: Brain Breaks® Video ExercisesOther: Posture training

Interventions

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.

BrainBreaks for people with mental health problemsBrainBreaks for people without mental health problems

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.

BrainBreaks for people with mental health problemsBrainBreaks for people without mental health problems

Eligibility Criteria

Age25 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsDue to hormonal levels the study will be done on a single sex.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Having a serious chronic illness,
  • It is a notification that physical activity and exercise are not appropriate due to a serious mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sedentary BehaviorSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

BehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

HABİBE SERAP S İNAL, PHD, PT

CONTACT

ÖZGE ECEM E ŞENEL, MSC, PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2023

First Posted

March 24, 2023

Study Start

March 5, 2023

Primary Completion

May 3, 2023

Study Completion

June 3, 2023

Last Updated

March 24, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations