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临床试验/NCT05511376
NCT05511376Unknown不适用

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

Bahçeşehir University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
Handgrip strength test

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Handgrip strength test

时间窗: 4th week

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

Biochemical parameters

时间窗: 4th week

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

Body Analysis

时间窗: 4th week

BIA measurements include (BMI (kg/m2)).

Anthropometric Measurements

时间窗: 4th week

It includes length (m) measurement.

Biophysical Methods

时间窗: 4th week

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.)

6-Min Walk Test

时间窗: 4th week

The 6-minute walk test includes value walking distance (m). (Increased walking distance indicates that functional values develop positively.)

次要结局

  • 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)

研究者

发起方
Bahçeşehir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gozde In

EXPERT PHYSIOTHERAPIST AND DIETICIAN

Bahçeşehir University

研究点 (2)

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