Intermittent Exercise Among Students

Evaluation the Effectiveness of Intermittent Anaerobic Exercise Among the Students With Cardiometabolic Risk

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiometabolic Risk
• Intervention / Treatment: Behavioral: Exercise programme

• Study Type: Interventional
• Enrollment (Anticipated): 370
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criterias:

• 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.

Exclusion Criterias:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard group; The participates in this group would provide normal health education of scientific and rational diet.
Experimental: Exercise intervention group; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Waist-to-height ratio	Waist-to-height ratio is calculated by the formula ：Waist-to-height ratio=waistline (cm)/height(cm). All the participates' Waist-to-height ratio would be calculated at baseline and 12th months after enrollment. The change would be manifested in the situatuion of the difference.	Baseline, 12th months after enrollment
Change of Body Mass Index	Body Mass Index is calculated by the formula ：Body Mass Index=weight(kg)/(height(cm))^2. All the participates' Body Mass Index would be calculated at baseline and 12th months after enrollment. The change would be manifested in the situatuion of the difference.	Baseline, 12th months after enrollment
Change of hipline	All the participates' hipline would be measured at baseline and 12th months after enrollment. The change would be manifested in the situatuion of the difference.	Baseline, 12th months after enrollment

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Study Chair: Weili Yan, PhD, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2021
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: children; cardiometabolic; Waist to height ratio, WHtR; Intermittent Anaerobic Exercise
• Other Study ID Numbers: IES-EKYY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No