NCT05949710

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 11, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

June 28, 2023

Last Update Submit

October 6, 2024

Conditions

ObesityInsulin ResistanceOverweight

Keywords

heart rate variabilityexerciseinflammationinsulin resistance

Outcome Measures

Primary Outcomes (9)

  • Heart rate variability

    will use heart rate variability analyzer

    two times and each session of exercise (change from baseline to the end of 16-week)

  • insulin resistance

    μIU/mL

    two times (change from baseline to the end of 16-week)

  • Visceral fat

    will use body composition analyzer

    two times (change from baseline to the end of 16-week)

  • fasting glucose

    mg/dL

    two times (change from baseline to the end of 16-week)

  • C-reactive protein

    mg/L

    two times (change from baseline to the end of 16-week)

  • Waist-to-hip ratio

    Waist-to-hip ratio

    two times (change from baseline to the end of 16-week)

  • Waist-to-height ratio

    Waist-to-height ratio

    two times (change from baseline to the end of 16-week)

  • body weight

    weight in Kilogram

    two times (change from baseline to the end of 16-week)

  • BMI

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

    two times (change from baseline to the end of 16-week)

Study Arms (2)

aerobic exercise(AE), normal weight

EXPERIMENTAL

3 times a week, normal weight

Behavioral: aerobic exercise(AE)

aerobic exercise(AE) , overweight/obese

EXPERIMENTAL

3 times a week, overweight/obese

Behavioral: aerobic exercise(AE)

Interventions

aerobic exercise(AE)BEHAVIORAL

The participants will receive AE three times per week.

aerobic exercise(AE) , overweight/obeseaerobic exercise(AE), normal weight

Eligibility Criteria

Age40 Years - 64 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsCompared to men, women tends to engage in community activities in Taiwan.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yu-Hsuan Chang

Tainan, 700, Taiwan

Location

MeSH Terms

Conditions

ObesityInsulin ResistanceOverweightMotor ActivityInflammation

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBehaviorPathologic Processes

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yu-Hsuan Chang, phD

    National Tainan Junior College of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The data analyzer (PI) will be blinded but the participants and intervener will not be.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Particiapnts will be divided into two groups: normal weight group and overweight/obese group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 28, 2023

First Posted

July 18, 2023

Study Start

September 11, 2023

Primary Completion

January 20, 2024

Study Completion

January 31, 2024

Last Updated

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

for research privacy.

Locations

TW(1)