Skip to content

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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05949710
Enrollment
51
Registered
2023-07-18
Start date
2023-09-11
Completion date
2024-01-31
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Obesity, Overweight

Keywords

heart rate variability, exercise, inflammation, insulin resistance

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.

Interventions

BEHAVIORALaerobic exercise(AE)

The participants will receive AE three times per week.

Sponsors

National Tainan Junior College of Nursing
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Intervention model description

Particiapnts will be divided into two groups: normal weight group and overweight/obese group.

Eligibility

Sex/Gender
ALL
Age
40 Years to 64 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Heart rate variabilitytwo times and each session of exercise (change from baseline to the end of 16-week)will use heart rate variability analyzer
insulin resistancetwo times (change from baseline to the end of 16-week)μIU/mL
Visceral fattwo times (change from baseline to the end of 16-week)will use body composition analyzer
fasting glucosetwo times (change from baseline to the end of 16-week)mg/dL
C-reactive proteintwo times (change from baseline to the end of 16-week)mg/L
Waist-to-hip ratiotwo times (change from baseline to the end of 16-week)Waist-to-hip ratio
Waist-to-height ratiotwo times (change from baseline to the end of 16-week)Waist-to-height ratio
body weighttwo times (change from baseline to the end of 16-week)weight in Kilogram
BMItwo times (change from baseline to the end of 16-week)weight and height will be combined to report BMI in kg/m\^2

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026