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

Primary Purpose

Obesity, Insulin Resistance, Overweight

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
aerobic exercise(AE)
Sponsored by
National Tainan Junior College of Nursing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring heart rate variability, exercise, inflammation, insulin resistance

Eligibility Criteria

40 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    No Intervention

    Experimental

    Experimental

    No Intervention

    Arm Label

    aerobic exercise(AE), group A

    control group, group B

    aerobic exercise(AE) , group C

    aerobic exercise(AE), group D

    control group, group E

    Arm Description

    3 times a week, normal weight

    control group, normal weight

    3 times a week, overweight

    5 times a week, overweight

    control group, overweight

    Outcomes

    Primary Outcome Measures

    Heart rate variability
    will use heart rate variability analyzer
    insulin resistance
    μIU/mL
    Visceral fat
    will use body composition analyzer
    fasting glucose
    mg/dL
    C-reactive protein
    mg/L
    Waist-to-hip ratio
    Waist-to-hip ratio
    Waist-to-height ratio
    Waist-to-height ratio
    body weight
    weight in Kilogram
    BMI
    weight and height will be combined to report BMI in kg/m^2

    Secondary Outcome Measures

    Full Information

    First Posted
    June 28, 2023
    Last Updated
    July 16, 2023
    Sponsor
    National Tainan Junior College of Nursing
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05949710
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 30, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2024 (Anticipated)
    Study Completion Date
    July 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Tainan Junior College of Nursing

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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 (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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Insulin Resistance, Overweight
    Keywords
    heart rate variability, exercise, inflammation, insulin resistance

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Particiapnts will be randomly divided into two groups for the participants in normal weight group (Group A and B) and divided into three groups for the participants in overweight group (Group C, D, and E), respectively.
    Masking
    Outcomes Assessor
    Masking Description
    This will be a single-blinded study, wherein the data analyzer (PI) will be blinded but the participants and intervener will not be.
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    aerobic exercise(AE), group A
    Arm Type
    Experimental
    Arm Description
    3 times a week, normal weight
    Arm Title
    control group, group B
    Arm Type
    No Intervention
    Arm Description
    control group, normal weight
    Arm Title
    aerobic exercise(AE) , group C
    Arm Type
    Experimental
    Arm Description
    3 times a week, overweight
    Arm Title
    aerobic exercise(AE), group D
    Arm Type
    Experimental
    Arm Description
    5 times a week, overweight
    Arm Title
    control group, group E
    Arm Type
    No Intervention
    Arm Description
    control group, overweight
    Intervention Type
    Behavioral
    Intervention Name(s)
    aerobic exercise(AE)
    Intervention Description
    The participants in Groups A and C will receive AE three times per week, and those in Group D will receive AE five times per week (the same supervised AE protocol three times a week with additional home-based AE training with an instructional video two times a week). The exercise movements in the instructional video will be identical to those of the supervised exercise to enable the participants to easily perform the exercise at home. The participants in the two control groups (Groups B and E) will maintain their original lifestyle without any exercise intervention during the 16 weeks.
    Primary Outcome Measure Information:
    Title
    Heart rate variability
    Description
    will use heart rate variability analyzer
    Time Frame
    two times and each session of exercise (change from baseline to the end of 16-week)
    Title
    insulin resistance
    Description
    μIU/mL
    Time Frame
    two times (change from baseline to the end of 16-week)
    Title
    Visceral fat
    Description
    will use body composition analyzer
    Time Frame
    two times (change from baseline to the end of 16-week)
    Title
    fasting glucose
    Description
    mg/dL
    Time Frame
    two times (change from baseline to the end of 16-week)
    Title
    C-reactive protein
    Description
    mg/L
    Time Frame
    two times (change from baseline to the end of 16-week)
    Title
    Waist-to-hip ratio
    Description
    Waist-to-hip ratio
    Time Frame
    two times (change from baseline to the end of 16-week)
    Title
    Waist-to-height ratio
    Description
    Waist-to-height ratio
    Time Frame
    two times (change from baseline to the end of 16-week)
    Title
    body weight
    Description
    weight in Kilogram
    Time Frame
    two times (change from baseline to the end of 16-week)
    Title
    BMI
    Description
    weight and height will be combined to report BMI in kg/m^2
    Time Frame
    two times (change from baseline to the end of 16-week)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yu-Hsuan Chang, phD
    Phone
    01188662110600
    Ext
    273
    Email
    fiona5252@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yu-Hsuan Chang, phD
    Organizational Affiliation
    National Tainan Junior College of Nursing
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    for research privacy.

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

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