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

NCT ID: NCT05949710

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-11

Study Completion Date

2024-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity Insulin Resistance Overweight

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Particiapnts will be divided into two groups: normal weight group and overweight/obese group.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The data analyzer (PI) will be blinded but the participants and intervener will not be.

Study Groups

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aerobic exercise(AE), normal weight

3 times a week, normal weight

Group Type EXPERIMENTAL

aerobic exercise(AE)

Intervention Type BEHAVIORAL

The participants will receive AE three times per week.

aerobic exercise(AE) , overweight/obese

3 times a week, overweight/obese

Group Type EXPERIMENTAL

aerobic exercise(AE)

Intervention Type BEHAVIORAL

The participants will receive AE three times per week.

Interventions

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aerobic exercise(AE)

The participants will receive AE three times per week.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

40 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Tainan Junior College of Nursing

OTHER

Sponsor Role lead

Responsible Party

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Yu-Hsuan Chang

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yu-Hsuan Chang, phD

Role: PRINCIPAL_INVESTIGATOR

National Tainan Junior College of Nursing

Locations

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Yu-Hsuan Chang

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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NTJCN

Identifier Type: -

Identifier Source: org_study_id

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