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

Comparison of the effects of combined IET with HIIT and HIIT on vascular function in young NWO women.

Study Overview

• Status: Completed
• Conditions: Normal Weight Obesity
• Intervention / Treatment: Behavioral: HIIT; Behavioral: HIIT combined IET

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: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Intima-Media Thickness (IMT)	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)	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

Outcome Measure	Measure Description	Time Frame
Body Composition Indicators	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)	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)	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)	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)	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

• Sponsor: Beijing Sport University

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: July 27, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: high-intensity interval training; isometric exercise training; normal weight obesity; vascular fitness
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Overweight; Obesity; Body Weight
• Other Study ID 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