Clinical trial NCT05949710: Explore the Relationship Between Heart Rate Variability, Body Mass Index, Inflammation, and Insulin Resistance.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Overweight
Keywords: heart rate variability
exercise
inflammation
insulin resistance
Lead sponsor: National Tainan Junior College of Nursing
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 51
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Particiapnts will be divided into two groups: normal weight group and overweight/obese group.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Heart rate variability
timeFrame: two times and each session of exercise (change from baseline to the end of 16-week)
measure: insulin resistance
timeFrame: two times (change from baseline to the end of 16-week)
measure: Visceral fat
timeFrame: two times (change from baseline to the end of 16-week)
measure: fasting glucose
timeFrame: two times (change from baseline to the end of 16-week)
measure: C-reactive protein
timeFrame: two times (change from baseline to the end of 16-week)
measure: Waist-to-hip ratio
timeFrame: two times (change from baseline to the end of 16-week)
measure: Waist-to-height ratio
timeFrame: two times (change from baseline to the end of 16-week)
measure: body weight
timeFrame: two times (change from baseline to the end of 16-week)
measure: BMI
timeFrame: two times (change from baseline to the end of 16-week)
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Yu-Hsuan Chang
Study officials:
affiliation: National Tainan Junior College of Nursing
name: Yu-Hsuan Chang, phD
role: PRINCIPAL_INVESTIGATOR
References: