Although obesity is a rapidly increasing epidemic worldwide, it is associated with many health-related comorbidities. As a result of the developments in social life and observes the sedentary life in individuals, an effect of the age of technology the fact that this epidemic will cause even massive health problems in the coming period affecting the health systems of countries and indirectly their economies that, This situation necessitates the creation of alternative treatment methods for the prevention of obesity. This study aims to determine the effect of a therapy approach that can be applied to the vagus nervous system, which is associated with many organs and systems, on weight loss and general health. As an alternative treatment against lifestyle changes such as diet and exercise, individuals have made for weight loss.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
For 4 weeks With the Vagustim device, in Biphasic, Frequency 10 Hz, Modulation mode, the pulse width of 300 μs, where the participants feel comfortable, the current intensity is kept constant for 30 minutes / 3 days/week. It will be applied as bilateral VSS from the tragus and turbinate parts of the ear.
For 4 weeks, Protein intake to 30% of total daily calories or 1-1.2 g/kg Personal nutrition program created for ideal body weight (by BMI values for age)
Exercise: Moderate Resistance Exercise Protocol (60 min 3 days a week )+ 30 min/day as aerobic exercise ( 5 days a week)
Avicenna Hospital
Istanbul, Turkey (Türkiye)
RECRUITINGBody Analysis
BIA measurements include (BMI (kg/m2)).
Time frame: Study start
Body Analysis
BIA measurements include (BMI (kg/m2)).
Time frame: 2nd week
Body Analysis
BIA measurements include (BMI (kg/m2)).
Time frame: 4th week
Body Analysis
BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).
Time frame: Study start
Body Analysis
BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).
Time frame: 2nd week
Body Analysis
BIA measurements include (Weight ( kg), Muscle and fat mass (kg), Body bone and fluid mass (kg), such as).
Time frame: 4th week
Body Analysis
BIA measurements include (Muscle and fat percentage (%) such as).
Time frame: Study start
Body Analysis
BIA measurements include (Muscle and fat percentage (%) such as).
Time frame: 2nd week
Body Analysis
BIA measurements include (Muscle and fat percentage (%) such as).
Time frame: 4th week
Body Analysis
BIA measurement include (Body density (mg/dl)).
Time frame: Study start
Body Analysis
BIA measurement include (Body density (mg/dl)).
Time frame: 2nd week
Body Analysis
BIA measurement include (Body density (mg/dl)).
Time frame: 4th week
Body Analysis
BIA measurement include (internal adiposity).
Time frame: Study start
Body Analysis
BIA measurement include (internal adiposity).
Time frame: 2nd week
Body Analysis
BIA measurement include (internal adiposity).
Time frame: 4th week
Anthropometric Measurements
It includes length (m) measurement.
Time frame: Study start
Anthropometric Measurements
It includes length (m) measurement.
Time frame: 2nd week
Anthropometric Measurements
It includes length (m) measurement.
Time frame: 4th week
Anthropometric Measurements
It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.
Time frame: Study start
Anthropometric Measurements
It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.
Time frame: 2nd week
Anthropometric Measurements
It includes waist (cm), hip (cm), upper arm (cm), thigh circumference (cm) and Skinfold thickness(cm) measurements.
Time frame: 4th week
Anthropometric Measurements
It includes waist-hip ratio measurements.
Time frame: Study start
Anthropometric Measurements
It includes waist-hip ratio measurements.
Time frame: 2nd week
Anthropometric Measurements
It includes waist-hip ratio measurements.
Time frame: 4th week
Biochemical parameters
It includes fasting blood sugar (mg/dL) value.
Time frame: Study start & 4th week
Biochemical parameters
It includes fasting blood sugar (mg/dL) value.
Time frame: Study start
Biochemical parameters
It includes HDL (mg/dL), LDL (mg/dL), TG (mg/dL), and Total cholesterol (mg/dL) values.
Time frame: 4th week
Biophysical Methods
It includes 5 X Sit-to-Stand Up test (sec). ( It show the temporal variation values in performing a certain activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)
Time frame: Study start
Biophysical Methods
It includes 5 X Sit-to-Stand Up test (sec). ( It show the temporal variation values in performing a certain activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)
Time frame: 2nd week
Biophysical Methods
It includes 5 X Sit-to-Stand Up test (sec). ( It show the temporal variation values in performing a certain activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)
Time frame: 4th week
Biophysical Methods
It includes the Stair Climb test (sec). ( It shows the temporal variation values in performing a particular activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)
Time frame: Study start
Biophysical Methods
It includes the Stair Climb test (sec). ( It shows the temporal variation values in performing a particular activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)
Time frame: 2nd week
Biophysical Methods
It includes the Stair Climb test (sec). ( It shows the temporal variation values in performing a particular activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)
Time frame: 4th week
Biophysical Methods
It includes The Timed Up and Go Test (sec). ( It show the temporal variation values in performing a certain activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)
Time frame: Study start
Biophysical Methods
It includes The Timed Up and Go Test (sec). ( It show the temporal variation values in performing a certain activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)
Time frame: 2nd week
Biophysical Methods
It includes The Timed Up and Go Test (sec). ( It show the temporal variation values in performing a certain activity. Functional activity and used to assess balance. Completion of test activity in a short time indicates positive development.)
Time frame: 4th week
6-Min Walk Test
The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)
Time frame: Study start
6-Min Walk Test
The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)
Time frame: 2nd week
6-Min Walk Test
The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)
Time frame: 4th week
6-Min Walk Test
The 6-minute walk test includes value Blood pressure (mmHg) measurements. (High blood pressure measurements approaching the normal value indicate that functional values develop positively.)
Time frame: Study start
6-Min Walk Test
The 6-minute walk test includes value Blood pressure (mmHg) measurements. (High blood pressure measurements approaching the normal value indicate that functional values develop positively.)
Time frame: 2nd week
6-Min Walk Test
The 6-minute walk test includes value Blood pressure (mmHg) measurements. (High blood pressure measurements approaching the normal value indicate that functional values develop positively.)
Time frame: 4th week
6-Min Walk Test
The 6-minute walk test includes value Modified Borg Dyspnea and Fatigue Scores. (Decreased dyspnea and fatigue scores indicate that functional values develop positively.)
Time frame: Study start
6-Min Walk Test
The 6-minute walk test includes value Modified Borg Dyspnea and Fatigue Scores. (Decreased dyspnea and fatigue scores indicate that functional values develop positively.)
Time frame: 2nd week
6-Min Walk Test
The 6-minute walk test includes value Modified Borg Dyspnea and Fatigue Scores. (Decreased dyspnea and fatigue scores indicate that functional values develop positively.)
Time frame: 4th week
6-Min Walk Test
The 6-minute walk test includes value Heart Rate. (Heart rate values being within the normal range for age indicate that functional values develop positively.)
Time frame: Study start
6-Min Walk Test
The 6-minute walk test includes value Heart Rate. (Heart rate values being within the normal range for age indicate that functional values develop positively.)
Time frame: 2nd week
6-Min Walk Test
The 6-minute walk test includes value Heart Rate. (Heart rate values being within the normal range for age indicate that functional values develop positively.)
Time frame: 4th week
6-Min Walk Test
The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)
Time frame: Study start
6-Min Walk Test
The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)
Time frame: 2nd week
6-Min Walk Test
The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)
Time frame: 4th week
Handgrip strength test
The Handgrip strength test (kg) measurement evaluates muscle strength.
Time frame: Study start
Handgrip strength test
The Handgrip strength test (kg) measurement evaluates muscle strength.
Time frame: 2nd week
Handgrip strength test
The Handgrip strength test (kg) measurement evaluates muscle strength.
Time frame: 4th week
International Physical Activity Questionnaire (Short Form- IPAQ)
It has been used to examine physical activity levels. (Weekly physical activity levels are measured by MET value calculations. An increase in MET values indicates an increase in activity.)
Time frame: Study start, 2nd & 4th week
Quality of Life Questionnaire (Short Form - SF-36)
It was used to evaluate the effect of weight on quality of life. (It is evaluated in the range of 0 - 100 points. Energy/vitality, physical function, mental health, general health perception, social functionality scores show a positive development as they approach the maximum value. Physical role difficulty, emotional role difficulty and Pain scores show a positive development as they approach the minimum value.)
Time frame: Study start, 2nd & 4th week
Food Cravings Questionnaire (FCQ)
It was used to determine the cravings for foods. (In the scale, a scoring system between 39-234 points is used for sub-dimensions.It shows that there is a positive development as the scale approaches the minimum result.)
Time frame: Study start & 4th week
Visual Analog Scale (VAS)
It was used to determine the cravings for foods. (A scoring system from 0 to 10 is used.It shows that there is a positive development as the scale approaches the minimum result.)
Time frame: Study start, 2nd & 4th week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.