ObesityNCT05949710
Explore the Relationship Between Heart Rate Variability, Body Mass Index, Inflammation, and Insulin Resistance.
A study testing aerobic exercise(AE) in people with Obesity and Insulin Resistance, run by National Tainan Junior College of Nursing at 1 site in Taiwan.
Trial summary
The findings will serve as a reference for clinical professionals to promote exercise among the general population for improving HRV. Read more about this study
- Who is it for?
- Ages 40 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Insulin Resistance, Overweight
- What is being tested?
- aerobic exercise(AE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Sep 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
The findings will serve as a reference for clinical professionals to promote exercise among the general population for improving HRV.
Read the 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.
- Conditions
- Obesity, Insulin Resistance, Overweight
- Being tested
- aerobic exercise(AE)
- Keywords
- heart rate variability, exercise, inflammation, insulin resistance
- Medical subject headings
- Obesity, Insulin Resistance, Overweight, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise(AE)Behavioural
The participants will receive AE three times per week.
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise(AE), normal weight | Experimental | 3 times a week, normal weight Receives: Behavioral: aerobic exercise(AE) |
| aerobic exercise(AE) , overweight/obese | Experimental | 3 times a week, overweight/obese Receives: Behavioral: aerobic exercise(AE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
will use heart rate variability analyzer
Measured: two times and each session of exercise (change from baseline to the end of 16-week)
insulin resistance
μIU/mL
Measured: two times (change from baseline to the end of 16-week)
Visceral fat
will use body composition analyzer
Measured: two times (change from baseline to the end of 16-week)
fasting glucose
mg/dL
Measured: two times (change from baseline to the end of 16-week)
C-reactive protein
mg/L
Measured: two times (change from baseline to the end of 16-week)
Waist-to-hip ratio
Waist-to-hip ratio
Measured: two times (change from baseline to the end of 16-week)
Waist-to-height ratio
Waist-to-height ratio
Measured: two times (change from baseline to the end of 16-week)
body weight
weight in Kilogram
Measured: 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
Measured: two times (change from baseline to the end of 16-week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start11 Sep 2023
- Primary completion20 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Particiapnts will be divided into two groups: normal weight group and overweight/obese group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Tainan Junior College of Nursing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Hsuan Chang, National Tainan Junior College of Nursing
- Investigators
- Yu-Hsuan Chang, phD, Principal investigator, National Tainan Junior College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949710
- Sponsor's protocol ID
- NTJCN
- Status last verified
- Oct 2024
- First submitted
- 28 Jun 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: for research privacy.
Publications
Chang YH, Shun SC, Hsu WL, Wu KLH. Effects of Aerobic Exercise on Heart Rate Variability and C-Reactive Protein in Middle-Aged Adults With Normal Weight and Overweight/Obesity: A Pilot Study. Res Nurs Health. 2026 May 20. doi: 10.1002/nur.70081. Online ahead of print.
PubMed 42159471
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05949710
- Acronym / sponsor ID
- NTJCN
- Conditions
- Obesity, Insulin Resistance, Overweight
- Keywords
- heart rate variability, exercise, inflammation, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National Tainan Junior College of NursingUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Particiapnts will be divided into two groups: normal weight group and overweight/obese group.
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise(AE), normal weight | Experimental | Behavioral: aerobic exercise(AE)3 times a week, normal weight |
| aerobic exercise(AE) , overweight/obese | Experimental | Behavioral: aerobic exercise(AE)3 times a week, overweight/obese |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exercise(AE)The participants will receive AE three times per week. | Behavioural | aerobic exercise(AE) , overweight/obese, aerobic exercise(AE), normal weight |
Primary outcome
Heart rate variability
Time frame: two times and each session of exercise (change from baseline to the end of 16-week)
will use heart rate variability analyzer
insulin resistance
Time frame: two times (change from baseline to the end of 16-week)
μIU/mL
Visceral fat
Time frame: two times (change from baseline to the end of 16-week)
will use body composition analyzer
fasting glucose
Time frame: two times (change from baseline to the end of 16-week)
mg/dL
C-reactive protein
Time frame: two times (change from baseline to the end of 16-week)
mg/L
Waist-to-hip ratio
Time frame: two times (change from baseline to the end of 16-week)
Waist-to-hip ratio
Waist-to-height ratio
Time frame: two times (change from baseline to the end of 16-week)
Waist-to-height ratio
body weight
Time frame: two times (change from baseline to the end of 16-week)
weight in Kilogram
BMI
Time frame: two times (change from baseline to the end of 16-week)
weight and height will be combined to report BMI in kg/m^2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Derived from this study: PubMed 42159471Chang YH, Shun SC, Hsu WL, Wu KLH. Effects of Aerobic Exercise on Heart Rate Variability and C-Reactive Protein in Middle-Aged Adults With Normal Weight and Overweight/Obesity: A Pilot Study. Res Nurs Health. 2026 May 20. doi: 10.1002/nur.70081. Online ahead of print.
- Individual participant dataSharing planned: No. for research privacy.
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Hsuan Chang, phD principal investigator
National Tainan Junior College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise(AE) in people with Obesity and Insulin Resistance, run by National Tainan Junior College of Nursing at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: two times and each session of exercise (change from baseline to the end of 16-week)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05949710, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.