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Clinical Trials/NCT05949710
NCT05949710
Completed
Not Applicable

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 Nursing1 site in 1 country51 target enrollmentSeptember 11, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
National Tainan Junior College of Nursing
Enrollment
51
Locations
1
Primary Endpoint
insulin resistance
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 11, 2023
End Date
January 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yu-Hsuan Chang

Assistant professor

National Tainan Junior College of Nursing

Eligibility Criteria

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).

Outcomes

Primary Outcomes

insulin resistance

Time Frame: two times (change from baseline to the end of 16-week)

μIU/mL

Visceral fat

Time Frame: two times (change from baseline to the end of 16-week)

will use body composition analyzer

Heart rate variability

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

will use heart rate variability analyzer

body weight

Time Frame: two times (change from baseline to the end of 16-week)

weight in Kilogram

Waist-to-height ratio

Time Frame: two times (change from baseline to the end of 16-week)

Waist-to-height ratio

fasting glucose

Time Frame: two times (change from baseline to the end of 16-week)

mg/dL

Waist-to-hip ratio

Time Frame: two times (change from baseline to the end of 16-week)

Waist-to-hip ratio

C-reactive protein

Time Frame: two times (change from baseline to the end of 16-week)

mg/L

BMI

Time Frame: two times (change from baseline to the end of 16-week)

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

Study Sites (1)

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