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

Obesity Clinical Trial

Official 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.

Status Recruiting

Clinical Trial Summary

The findings will serve as a reference for clinical professionals to promote exercise among the general population and will provide evidence of whether different exercise amounts are recommended for individuals with different BMIs for improving HRV.

Clinical Trial 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 (1) compare the effects of AE training in improving HRV, inflammatory markers, and insulin resistance between community residents with normal weight and overweight and (2) compare the effects of various amounts of AE on the improvement of HRV, inflammatory markers, and insulin resistance among community residents with overweight/obesity.

Methods: A randomized control trial with purposive sampling will be used to recruit community residents aged 40-64 years with inactive habits in southern Taiwan. To obtain the targeted sample size of 96 participants, including 42 participants with normal weight and 54 participants with overweight, the study will conduct three recruitment waves and 16-week interventions. The participants with normal weight will be further randomly allocated to a group receiving AE training with at least moderate intensity three times per week or a control group, whereas the participants with overweight will be randomly allocated to a group receiving the same prescribed AE training three times per week, a group receiving AE training five times per week (with additional home-based exercise two times per week), or a control group. HRV parameters, blood samples, and visceral fat will be evaluated. The blood samples will be evaluated for adipocytokines (adiponectin and leptin), proflammatory cytokines (interleukin-1 and interleukin-6), and markers of insulin resistance (fasting glucose, insulin, glucagon-like peptide-1, and dipeptidyl peptidase-4). 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 and whether higher exercise amounts contribute to greater improvements in HRV in the overweight group. Relevance to clinical practice: The findings will serve as a reference for clinical professionals to promote exercise among the general population and will provide evidence of whether different exercise amounts are recommended for individuals with different BMIs for improving HRV. ;

Related Conditions & MeSH terms

• Inflammation
• Insulin Resistance
• Obesity
• Overweight

• NCT number: NCT05949710
• Study type: Interventional
• Source: National Tainan Junior College of Nursing
• Contact: Yu-Hsuan Chang, phD
• Phone: 01188662110600
• Email: fiona5252@hotmail.com
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2023
• Completion date: July 31, 2024