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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Visceral fat
Study 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.
Study Design
- Study Type
- Interventional
- 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.
Eligibility Criteria
- Ages
- 40 Years to 64 Years (Adult)
- Sex
- All
- Accepts 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).
Arms & Interventions
aerobic exercise(AE), normal weight
3 times a week, normal weight
Intervention: aerobic exercise(AE) (Behavioral)
aerobic exercise(AE) , overweight/obese
3 times a week, overweight/obese
Intervention: aerobic exercise(AE) (Behavioral)
Outcomes
Primary Outcomes
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
insulin resistance
Time Frame: two times (change from baseline to the end of 16-week)
μIU/mL
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Yu-Hsuan Chang
Assistant professor
National Tainan Junior College of Nursing