Determining the effect of 8 weeks of high-intensity and cognitive functional training on inhibitory control and brain activity in overweight and obese women
Design
Clinical trial with control groups, with parallel groups, unblinded, non-randomized on 40 people
Settings and conduct
The levels of this research will be carried out in the Faculty of Sports and Health Sciences of Shahid Beheshti University and the National Brain Mapping Laboratory of Tehran University.
After grouping, in pre-test body composition, a go/no-go task will be conducted to evaluate inhibitory control and record brain activity using the fNIRS method. After two months of high-intensity functional training (a combination of aerobic and strength training that will be 3 sessions of 1 hour per week) and a game (a mobile game designed to strengthen inhibitory control, 20 minutes daily) in the post-test, the cases Measured in the pre-test will be checked again.
Participants/Inclusion and exclusion criteria
Inclusion criteria BMI greater than 25, right-handedness
No history of using mobile and computer games and high intensity functional training.
Exclusion criteria: Not using weight loss programs (exercise, diet, medicine, etc.).
No history of chronic disease, neurological disorders and special medical or orthopedic conditions
Not during pregnancy and breastfeeding.
Intervention groups
Intervention groups: Control group: will not receive any intervention during the research period. High-intensity functional training group: will receive the exercise training intervention. Game group: will receive the game intervention. Combined group: will receive the intervention of exercise training and games during the research period.
Main outcome variables
Inhibitory control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221026056301N1
Registration date:2022-12-26, 1401/10/05
Registration timing:registered_while_recruiting
Last update:2022-12-26, 1401/10/05
Update count:0
Registration date
2022-12-26, 1401/10/05
Registrant information
Name
Marzieh Bagheri
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 919 302 4326
Email address
mzbagheri681@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-11, 1401/09/20
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks of high-intensity functional training and gamification on inhibitory control and brain activity in overweight and obese women
Public title
The effect of exercise training and gamification on inhibitory control and brain activity in overweight and obese women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index greater than 25
Being right-handed
No history of using mobile and computer games for more than 2 hours per week in the past 12 months
No experience of high-intensity functional training
Not participating in a regular exercise program for more than 2 hours per week in the past12 months
Exclusion criteria:
Overweight and obesity are not due to the use of medicine.
Not using weight loss programs (exercise, diet, medicine, etc.) during the last 12 months
No history of chronic disease (diabetes, blood pressure, cardiovascular diseases, etc.)
No history of neurological and psychiatric disorders (eating disorder, depression, etc.)
Absence of medical or orthopedic conditions that prohibits doing exercises.
Not during pregnancy and breastfeeding.
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Shahid Beheshti University
Street address
Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2022-10-07, 1401/07/15
Ethics committee reference number
IR.SBU.REC.1401.109
Health conditions studied
1
Description of health condition studied
Obesity due to excess calories
ICD-10 code
E66.0
ICD-10 code description
چاقی به دلیل کالری اضافی
Primary outcomes
1
Description
Inhibitory control
Timepoint
At the beginning of the study and after 2 months of exercise training and cognitive training.
Method of measurement
In the study "Effect of exercise and cognitive training on inhibitory control and brain activity", the method of measuring inhibitory control can be the Go/No-go task. Also, the method of measuring brain activities can be the Functional near-infrared spectroscopy method.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In this study, the control group will not receive any intervention. Also, at the beginning of the study and after 2 months, measurements of body composition, inhibitory control and brain activity will be done.
Category
N/A
2
Description
The first intervention group: the group of high-intensity functional training, which in this study will perform high-intensity functional exercises training for 2 months, 3 sessions a week for 1 hour under the supervision of the researcher. Each session, participants will first warm up for 10 to 15 minutes using aerobic activities such as running and stretching, then for the main part of the training, a combination of aerobic activities (such as jumping rope), strength activities for the upper body (such as power swimming ), the lower body (such as squats) and the central part of the body (such as sit-ups) will be used for 40-45 minutes. At the end of the session, stretching movements will be used to cool down for 10 to 15 minutes to return to the initial state.
Category
N/A
3
Description
The second intervention group: The game group in this study will play a mobile game designed to strengthen inhibitory control daily for 20 minutes for 2 months. This game is a serious game and is designed to target inhibitory control behavior related to eating. Also, the stages of the game are varied from easy to difficult.
Category
N/A
4
Description
The fourth intervention group: The combined group in this study will perform high-intensity functional exercises for 2 months at the same time, 3 sessions of 1 hour per week (the details of the intervention are described in the second intervention group). Also, they will play a mobile game designed to strengthen inhibitory control for 20 minutes daily (the details of the intervention are described in the third intervention group).