Regulation of HIIT Combined with IET on Vascular Function in Young Women with Normal Weight Obesity

October 24, 2024 updated by: Beijing Sport University
Comparison of the effects of combined IET with HIIT and HIIT on vascular function in young NWO women.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized clinical trial of single-blind with 3 arms (control group , HIIT group and IET with HIIT group), in which a pre-treatment-posttest design has been used.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • School of Sports Medicine and Rehabilitation, Beijing Sport University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female, aged between 18 and 30 years old;
  • BMI between 18.5 and 24.9 kg/m2 with a BF% > 30% (normal weight obesity determination criteria);
  • exercise capacity to complete the exercise programme.

Exclusion Criteria:

  • Acute or chronic musculoskeletal disorders, cardiovascular diseases, etc. that prevented training;
  • other diseases (such as diabetes, etc.) that had a great impact on physical condition;
  • bad habits (such as smoking, drinking, etc.);
  • and unstable body weight (up and down fluctuations of more than 2.5 kg) in the 3 months before the experiment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Active Comparator: HIIT group
Behavioral: HIIT
high intensity interval training
Active Comparator: HIIT combined IET group
Behavioral: HIIT combined IET
high intensity interval training combined with isometric exercise training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intima-Media Thickness (IMT)
Time Frame: 8 weeks
The subjects were required to sit still for 5～10 minutes before the test, and the carotid artery structural and functional parameters were recorded using a GE vivid 7 colour ultrasound instrument from the United States as follows: the subjects were required to lie in the supine position, and the probe was used to sweep longitudinally along the outer edge of the sternocleidomastoid muscle, and the maximal Intima-media thickness (IMT) was measured. Changes in Intima media thickness before and after intervention.
8 weeks
Flow-Mediated Dilation (FMD)
Time Frame: 8 weeks
Vascular endothelial function was measured with a Japanese-made UNEX EF vascular endothelial function tester. Pressure was applied on top of the resting blood pressure and the ischaemic process was performed for 5 min. At the end of the ischaemic process, the pressure band was removed and flow-mediated dilation (FMD) of the brachial artery was calculated. Changes in Flow-mediated dilation before and after Intervention
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Composition Indicators
Time Frame: 8 weeks
Body composition indicators analysis was assessed using DXA. Body composition indicators include: fat mass(kg), lean body mass(kg), percentage of body fat(%).
8 weeks
Body Mass Index (BMI)
Time Frame: 8 weeks
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat. Changes in Body mass index before and after Intervention.
8 weeks
Blood Pressure (BP)
Time Frame: 8 weeks
Quiet blood pressure: Systolic and diastolic blood pressures are measured using a standard mercury sphygmomanometer. Changes in blood pressure before and after intervention, including systolic blood pressure, diastolic blood pressure, and pulse pressure difference.
8 weeks
Pulse Wave Velocity (PWV) and ankle brachial index (ABI)
Time Frame: 8 weeks
The testing instrument is Omron Atherosclerosis Tester (BP-203RPEIII). During the test, the subjects need to expose their limbs, lie flat on the bed, and keep their bodies relaxed. At the same time, they need to tie cuffs around their limbs to avoid any physical movement and ensure the accuracy of the test results. The unit of PWV is (cm/s), and ABI is a numerical value. Changes in Pulse wave velocity and ankle brachial index before and after Intervention.
8 weeks
Volume Oxygen Maximum (VO2max)
Time Frame: 8 weeks
During the test, gradually increasing loads were performed using the Bruce running table protocol, and gas metabolism metrics were obtained at each stage of exercise using a portable Cortex-3B gas metabolism analyser. Changes in Volume oxygen maximum before and after Intervention.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Sport University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RHCIVFYWNWO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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