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Dose-effect of HIIT on Cardiovascular Health of Children

Primary Purpose

Cardiovascular Diseases Risk, Adiposity

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

High intensity interval training

Nutritional education

About this trial

This is an interventional prevention trial for Cardiovascular Diseases Risk focused on measuring HIIT, nutritional education, Dose-effect, school, children, cardiovascular, adiposity, blood pressure, fitness

Eligibility Criteria

9 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All school children able to attend the physical education sessions of the school

Exclusion Criteria:

Children with medical condition that limits physical activity

Sites / Locations

Department of Health Sciences, Universidad Pública de Navarra

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

HIIT two sessions

HIIT one session

Nutritional education

Arm Description

Two sessions per week of HIIT + nutritional education (1 session/week)

One session per week of HIIT + nutritional education (1 session/week)

Nutritional education (1 session/week)

Outcomes

Primary Outcome Measures

Change in cardiorespiratory fitness

20m shuttle run test (Alpha battery)

Secondary Outcome Measures

Change in Body fat

Body fat percent measured by bioimpedance

Change in Ankle-brachial index

Automated simultaneous blood pressure measurement

Change in Dietary habits

Food frequency questionnaire and 24h recall

Change in Muscular strength

Handgrip strength and long jump (Alpha battery)

Change in speed-agility

4x10m speed agility test (Alpha battery)

Full Information

NCT ID

NCT03479658

First Posted

February 20, 2018

Last Updated

October 2, 2018

Sponsor

Universidad Pública de Navarra

1. Study Identification

Unique Protocol Identification Number

NCT03479658

Brief Title

Dose-effect of HIIT on Cardiovascular Health of Children

Official Title

Dose-effect of HIIT on Cardiovascular Health of Children Aged 9 to 10 Years Old Participating in a School Based Multidisciplinary Intervention Program: a Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

February 27, 2018 (Actual)

Primary Completion Date

June 20, 2018 (Actual)

Study Completion Date

September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Pública de Navarra

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

An adequate physical activity level has important effects on cardiovascular health of children. However, the scientific literature suggests that few children meet the physical activity recommendations to obtain these cardiovascular benefits which may have immediate and long term consequences in public health. High intensity interval training (HIIT) has emerged as an effective strategy for improving physical and mental health in children. To note that HIIT can be completed in a shorter period of time and its results in physical health seem to be equivalent to those obtained in longer sessions of traditional aerobic training. However, there is no information about the dose of HIIT needed to obtain significant effects on cardiovascular health of children. The adoption of healthy dietary habits is also important in the prevention of obesity and cardiovascular diseases. School-based programs including physical activity and nutritional education have been recommended as important components of programs aiming to prevent obesity and cardiovascular diseases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Diseases Risk, Adiposity

Keywords

HIIT, nutritional education, Dose-effect, school, children, cardiovascular, adiposity, blood pressure, fitness

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HIIT two sessions

Arm Type

Experimental

Arm Description

Two sessions per week of HIIT + nutritional education (1 session/week)

Arm Title

HIIT one session

Arm Type

Experimental

Arm Description

One session per week of HIIT + nutritional education (1 session/week)

Arm Title

Nutritional education

Arm Type

Active Comparator

Arm Description

Nutritional education (1 session/week)

Intervention Type

Behavioral

Intervention Name(s)

High intensity interval training

Intervention Description

Two schools with four classes/groups of 4th degree of children will participate in the pilot study (i.e., age of children 9-10 years old). One of them has two physical education (PE) sessions per week and the other has only one PE session per week. In the school with two PE sessions, two classes will be randomly assigned to HIIT (2 sessions/week) +nutrition group, and two to the nutrition group. Similarly, in the school with one PE session per week, two classes will be randomly assigned to HIIT (1 session/week) + nutrition and two classes to the nutrition goup. Both HIIT and nutritional education sessions will be integrated integrated into the physical education and sciences sessions of the schools. The duration of the intervention will be of eight weeks.

Intervention Type

Behavioral

Intervention Name(s)

Nutritional education

Intervention Description

School-based nutritional education on healthy dietary habits

Primary Outcome Measure Information:

Title

Change in cardiorespiratory fitness

Description

20m shuttle run test (Alpha battery)

Time Frame

Change from baseline cardiorespiratory fitness at eight weeks

Secondary Outcome Measure Information:

Title

Change in Body fat

Description

Body fat percent measured by bioimpedance

Time Frame

Change from baseline body fat at eight weeks

Title

Change in Ankle-brachial index

Description

Automated simultaneous blood pressure measurement

Time Frame

Change from baseline Ankle-brachial index at eight weeks

Title

Change in Dietary habits

Description

Food frequency questionnaire and 24h recall

Time Frame

Change from baseline Dietary habits at eight weeks

Title

Change in Muscular strength

Description

Handgrip strength and long jump (Alpha battery)

Time Frame

Change from baseline Muscular strength at eight weeks

Title

Change in speed-agility

Description

4x10m speed agility test (Alpha battery)

Time Frame

Change from baseline speed agility at eight weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All school children able to attend the physical education sessions of the school - Exclusion Criteria: Children with medical condition that limits physical activity

Facility Information:

Facility Name

Department of Health Sciences, Universidad Pública de Navarra

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

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Dose-effect of HIIT on Cardiovascular Health of Children

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