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Explore the Relationship Between Heart Rate Variability, Body Mass Index, Inflammation, and Insulin Resistance.

Not Applicable
Completed
Conditions
Insulin Resistance
Overweight
Obesity
Interventions
Behavioral: aerobic exercise(AE)
Registration Number
NCT05949710
Lead Sponsor
National Tainan Junior College of Nursing
Brief Summary

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

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
51
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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).

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
aerobic exercise(AE), normal weightaerobic exercise(AE)3 times a week, normal weight
aerobic exercise(AE) , overweight/obeseaerobic exercise(AE)3 times a week, overweight/obese
Primary Outcome Measures
NameTimeMethod
Visceral fattwo times (change from baseline to the end of 16-week)

will use body composition analyzer

insulin resistancetwo times (change from baseline to the end of 16-week)

μIU/mL

Heart rate variabilitytwo times and each session of exercise (change from baseline to the end of 16-week)

will use heart rate variability analyzer

body weighttwo times (change from baseline to the end of 16-week)

weight in Kilogram

Waist-to-height ratiotwo times (change from baseline to the end of 16-week)

Waist-to-height ratio

fasting glucosetwo times (change from baseline to the end of 16-week)

mg/dL

Waist-to-hip ratiotwo times (change from baseline to the end of 16-week)

Waist-to-hip ratio

C-reactive proteintwo times (change from baseline to the end of 16-week)

mg/L

BMItwo times (change from baseline to the end of 16-week)

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Yu-Hsuan Chang

🇨🇳

Tainan, Taiwan

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