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Clinical Trials/NCT05511376
NCT05511376
Unknown
Not Applicable

Comparison of Diet, Exercise, and Auricular Vagus Nerve Stimulation Efficacy for Weight Reduction in Obese Individuals

Bahçeşehir University1 site in 1 country90 target enrollmentJuly 1, 2021
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Bahçeşehir University
Enrollment
90
Locations
1
Primary Endpoint
Biophysical Methods
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
August 26, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bahçeşehir University
Responsible Party
Principal Investigator
Principal Investigator

Gozde In

EXPERT PHYSIOTHERAPIST AND DIETICIAN

Bahçeşehir University

Eligibility Criteria

Inclusion Criteria

  • Age range 18 - 65
  • Being in the stage I, II and III obesity class

Exclusion Criteria

  • Those with unstable DM
  • Those with stage II hypertension
  • Those who have had cardiovascular disease (especially those who have had an attack)
  • Those with pulmonary disease
  • Those with kidney disease
  • Orthopedic restrictions
  • Those with MND
  • Those tied to the chair

Outcomes

Primary Outcomes

Biophysical Methods

Time Frame: 4th week

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.)

6-Min Walk Test

Time Frame: 4th week

The 6-minute walk test includes value O2 saturation (mmHg). (Increased O2 saturation indicates that functional values develop positively.)

Handgrip strength test

Time Frame: 4th week

The Handgrip strength test (kg) measurement evaluates muscle strength.

Body Analysis

Time Frame: 4th week

BIA measurement include (internal adiposity).

Anthropometric Measurements

Time Frame: 4th week

It includes waist-hip ratio measurements.

Biochemical parameters

Time Frame: 4th week

It includes HDL (mg/dL), LDL (mg/dL), TG (mg/dL), and Total cholesterol (mg/dL) values.

Secondary Outcomes

  • Quality of Life Questionnaire (Short Form - SF-36)(Study start, 2nd & 4th week)
  • International Physical Activity Questionnaire (Short Form- IPAQ)(Study start, 2nd & 4th week)
  • Food Cravings Questionnaire (FCQ)(Study start & 4th week)
  • Visual Analog Scale (VAS)(Study start, 2nd & 4th week)

Study Sites (1)

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