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.

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

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Insulin Resistance
• Intervention / Treatment: Behavioral: aerobic exercise(AE)

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 700
    • Yu-Hsuan Chang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aerobic exercise(AE), normal weight; 3 times a week, normal weight	Behavioral: aerobic exercise(AE); The participants will receive AE three times per week.
Experimental: aerobic exercise(AE) , overweight/obese; 3 times a week, overweight/obese	Behavioral: aerobic exercise(AE); The participants will receive AE three times per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability	will use heart rate variability analyzer	two times and each session of exercise (change from baseline to the end of 16-week)
insulin resistance	μIU/mL	two times (change from baseline to the end of 16-week)
Visceral fat	will use body composition analyzer	two times (change from baseline to the end of 16-week)
fasting glucose	mg/dL	two times (change from baseline to the end of 16-week)
C-reactive protein	mg/L	two times (change from baseline to the end of 16-week)
Waist-to-hip ratio	Waist-to-hip ratio	two times (change from baseline to the end of 16-week)
Waist-to-height ratio	Waist-to-height ratio	two times (change from baseline to the end of 16-week)
body weight	weight in Kilogram	two times (change from baseline to the end of 16-week)
BMI	weight and height will be combined to report BMI in kg/m^2	two times (change from baseline to the end of 16-week)

Collaborators and Investigators

• Sponsor: National Tainan Junior College of Nursing
• Investigators: Principal Investigator: Yu-Hsuan Chang, phD, National Tainan Junior College of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Actual): January 20, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: July 16, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 6, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: exercise; inflammation; insulin resistance; heart rate variability
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Hyperinsulinism; Inflammation; Insulin Resistance; Overweight
• Other Study ID Numbers: NTJCN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: for research privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No