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临床试验/NCT05949710
NCT05949710已完成不适用

Explore the Relationship Between Heart Rate Variability, Body Mass Index, Inflammation, and Insulin Resistance: From a Population-based Survey to Multi-arms of Aerobic Exercise Intervention.

National Tainan Junior College of Nursing2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2023年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
insulin resistance

研究概览

简要总结

The findings will serve as a reference for clinical professionals to promote exercise among the general population for improving HRV.

详细描述

Background: Heart rate variability (HRV) measurement is widely used to assess the function of cardiac autonomic modulation. Aerobic exercise (AE) has been proven to improve HRV. However, because HRV is highly associated with visceral fat, inflammatory status, and insulin resistance, whether baseline body inflammation status can explain the heterogeneous response to AE remains unknown.

Purposes: We will compare the effects of AE training in improving HRV, inflammatory markers, and insulin resistance between community residents with normal weight and overweight/obesity.

Methods: A quasi-experimental study with purposive sampling will be used to recruit community residents aged 40-64 years with inactive habits in southern Taiwan. The minimum targeted sample size is 43 participants. The participants will be grouped into normal weight and overweight/obese groups. All participants will receive AE training with at least moderate intensity three times per week. HRV parameters, blood samples, and visceral fat will be evaluated. The blood samples will be evaluated for C-reactive protein and markers of insulin resistance (fasting glucose, insulin). All participants will be evaluated at baseline (T0) and after a 16-week intervention (T1). In addition to these time points, HRV will be measured during every exercise session for participants in exercise groups. Generalized estimating equations will be used to determine whether baseline BMI is the key factor influencing the effects of AE.

Relevance to clinical practice: The findings will serve as a reference for clinical professionals to promote exercise among the general population for improving HRV.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The data analyzer (PI) will be blinded but the participants and intervener will not be.

入排标准

年龄范围
40 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • are aged between 40 and 64 years.
  • had inactive habit (<3 days of physical activity per week and <30 minutes per session).
  • can communicate in Mandarin or Taiwanese.

排除标准

  • underlying conditions, such as stroke, acute coronary artery diseases, handicap, pregnancy, and unstable hypertension, that may present risks for exercise training.
  • smoking or alcohol abuse.
  • currently being on a diet, and (d) lifestyles that may affect HRV and inflammatory biomarkers (e.g., shift work or habit of staying up late).

结局指标

主要结局

insulin resistance

时间窗: two times (change from baseline to the end of 16-week)

μIU/mL

Visceral fat

时间窗: two times (change from baseline to the end of 16-week)

will use body composition analyzer

Heart rate variability

时间窗: two times and each session of exercise (change from baseline to the end of 16-week)

will use heart rate variability analyzer

body weight

时间窗: two times (change from baseline to the end of 16-week)

weight in Kilogram

Waist-to-height ratio

时间窗: two times (change from baseline to the end of 16-week)

Waist-to-height ratio

fasting glucose

时间窗: two times (change from baseline to the end of 16-week)

mg/dL

Waist-to-hip ratio

时间窗: two times (change from baseline to the end of 16-week)

Waist-to-hip ratio

C-reactive protein

时间窗: two times (change from baseline to the end of 16-week)

mg/L

BMI

时间窗: two times (change from baseline to the end of 16-week)

weight and height will be combined to report BMI in kg/m\^2

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu-Hsuan Chang

Assistant professor

National Tainan Junior College of Nursing

研究点 (2)

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