NCT04359433

Brief Summary

Evaluate the effectiveness of intermittency anaerobic exercise interventions among the students with high risk of cardiometabolic .

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 2, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

3.1 years

First QC Date

April 21, 2020

Last Update Submit

May 11, 2024

Conditions

Keywords

cardiometabolicchildrenWaist to height ratio, WHtRIntermittent Anaerobic Exercise

Outcome Measures

Primary Outcomes (1)

  • Abnormal of cardiometabolic risk related index

    Cardiometabolic risk related index includes fasting blood glucose, blood lipids, blood pressure and abdominal obesity.Cardiometabolic risk related index would be set to 1 as at least 2 indexs mentioned were abnormal while 0 for less than 2.

    3th month after enrollment

Secondary Outcomes (3)

  • Change of Waist-to-height ratio

    Baseline, 12th months after enrollment

  • Change of Body Mass Index

    Baseline, 12th months after enrollment

  • Change of hipline

    Baseline, 12th months after enrollment

Study Arms (2)

Standard group

NO INTERVENTION

The participates in this group would provide normal health education of scientific and rational diet.

Exercise intervention group

EXPERIMENTAL

Besides normal health education of scientific and rational diet,the participates in this group would be suggested to carry out an anaerobic exercise named Tabata.

Behavioral: Exercise programme

Interventions

Exercise programme includes 8 anaerobic movements choosen from Tabata. This exercise programme workout is aimed at body fat reduction, and the structure is as follows: * 8 anerobic movements in 20 seconds is a set * Rest for 10 seconds before another set * Finish 4 sets every time, it shall take you 4 minutes * Do 4 sets 2 to 3 times a week

Exercise intervention group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male: Waist-to-height ratio≥0.463
  • Female: Waist-to-height ratio≥0.469
  • Students with cardiometabolic risk factors include elevated BP, dyslipidaemia, elevated fasting blood glucose (FBG) and central obesity.

You may not qualify if:

  • Participates with severe disease conditions include cardiac insufficiency, respiratory system relate diseases, immunodeficiency or severe malnutrition, ect
  • Taking or having taken weight-loss drugs
  • Participates unsuitable or improper to participate the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, China

Location

Study Officials

  • Weili Yan, PhD

    Children's Hospital of Fudan University

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

August 2, 2021

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations