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

Sponsor
National Tainan Junior College of Nursing (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05949710
Collaborator
(none)
96
5
10

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: aerobic exercise(AE)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Single (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.
Primary Purpose:
Prevention
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.
Anticipated Study Start Date :
Sep 30, 2023
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: aerobic exercise(AE), group A

3 times a week, normal weight

Behavioral: aerobic exercise(AE)
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.

No Intervention: control group, group B

control group, normal weight

Experimental: aerobic exercise(AE) , group C

3 times a week, overweight

Behavioral: aerobic exercise(AE)
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.

Experimental: aerobic exercise(AE), group D

5 times a week, overweight

Behavioral: aerobic exercise(AE)
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.

No Intervention: control group, group E

control group, overweight

Outcome Measures

Primary Outcome Measures

  1. Heart rate variability [two times and each session of exercise (change from baseline to the end of 16-week)]

    will use heart rate variability analyzer

  2. insulin resistance [two times (change from baseline to the end of 16-week)]

    ╬╝IU/mL

  3. Visceral fat [two times (change from baseline to the end of 16-week)]

    will use body composition analyzer

  4. fasting glucose [two times (change from baseline to the end of 16-week)]

    mg/dL

  5. C-reactive protein [two times (change from baseline to the end of 16-week)]

    mg/L

  6. Waist-to-hip ratio [two times (change from baseline to the end of 16-week)]

    Waist-to-hip ratio

  7. Waist-to-height ratio [two times (change from baseline to the end of 16-week)]

    Waist-to-height ratio

  8. body weight [two times (change from baseline to the end of 16-week)]

    weight in Kilogram

  9. BMI [two times (change from baseline to the end of 16-week)]

    weight and height will be combined to report BMI in kg/m^2

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 64 Years
Sexes Eligible for Study:
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • National Tainan Junior College of Nursing

Investigators

  • Principal Investigator: Yu-Hsuan Chang, phD, National Tainan Junior College of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yu-Hsuan Chang, Assistant professor, National Tainan Junior College of Nursing
ClinicalTrials.gov Identifier:
NCT05949710
Other Study ID Numbers:
  • NTJCN
First Posted:
Jul 18, 2023
Last Update Posted:
Jul 18, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yu-Hsuan Chang, Assistant professor, National Tainan Junior College of Nursing
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2023