NCT06556875

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
Last Updated

October 28, 2024

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

July 27, 2024

Last Update Submit

October 24, 2024

Conditions

Keywords

isometric exercise traininghigh-intensity interval trainingnormal weight obesityvascular fitness

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Body Composition Indicators

    8 weeks

  • Body Mass Index (BMI)

    8 weeks

  • Blood Pressure (BP)

    8 weeks

  • Pulse Wave Velocity (PWV) and ankle brachial index (ABI)

    8 weeks

  • Volume Oxygen Maximum (VO2max)

    8 weeks

Study Arms (3)

HIIT group

ACTIVE COMPARATOR
Behavioral: HIIT

HIIT combined IET group

ACTIVE COMPARATOR
Behavioral: HIIT combined IET

Control group

NO INTERVENTION

Interventions

HIITBEHAVIORAL

high intensity interval training

HIIT group

high intensity interval training combined with isometric exercise training

HIIT combined IET group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Sports Medicine and Rehabilitation, Beijing Sport University

Beijing, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2024

First Posted

August 16, 2024

Study Start

February 23, 2023

Primary Completion

September 30, 2023

Study Completion

December 30, 2023

Last Updated

October 28, 2024

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations