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Completed

NCT Number: NCT05949710

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

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

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Key information

Conditions

Obesity Behavior Body Weight Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yu-Hsuan Chang

Tainan, 700, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

aerobic exercise(AE)

Behavioral

The participants will receive AE three times per week.

Primary outcomes

  1. 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

  2. insulin resistance

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

    μIU/mL

  3. Visceral fat

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

    will use body composition analyzer

  4. fasting glucose

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

    mg/dL

  5. C-reactive protein

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

    mg/L

  6. Waist-to-hip ratio

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

    Waist-to-hip ratio

  7. Waist-to-height ratio

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

    Waist-to-height ratio

  8. body weight

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

    weight in Kilogram

  9. 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

Sponsors and collaborators

Lead sponsor

National Tainan Junior College of Nursing

Other

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2023
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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