Dose-effect of HIIT on Cardiovascular Health of Children

Sponsor
Universidad Pública de Navarra (Other)
Overall Status
Completed
CT.gov ID
NCT03479658
Collaborator
(none)
180
1
3
7.1
25.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: High intensity interval training
  • Behavioral: Nutritional education
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Feb 27, 2018
Actual Primary Completion Date :
Jun 20, 2018
Actual Study Completion Date :
Sep 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: HIIT two sessions

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

Behavioral: High intensity interval training
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.

Behavioral: Nutritional education
School-based nutritional education on healthy dietary habits

Experimental: HIIT one session

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

Behavioral: High intensity interval training
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.

Behavioral: Nutritional education
School-based nutritional education on healthy dietary habits

Active Comparator: Nutritional education

Nutritional education (1 session/week)

Behavioral: Nutritional education
School-based nutritional education on healthy dietary habits

Outcome Measures

Primary Outcome Measures

  1. Change in cardiorespiratory fitness [Change from baseline cardiorespiratory fitness at eight weeks]

    20m shuttle run test (Alpha battery)

Secondary Outcome Measures

  1. Change in Body fat [Change from baseline body fat at eight weeks]

    Body fat percent measured by bioimpedance

  2. Change in Ankle-brachial index [Change from baseline Ankle-brachial index at eight weeks]

    Automated simultaneous blood pressure measurement

  3. Change in Dietary habits [Change from baseline Dietary habits at eight weeks]

    Food frequency questionnaire and 24h recall

  4. Change in Muscular strength [Change from baseline Muscular strength at eight weeks]

    Handgrip strength and long jump (Alpha battery)

  5. Change in speed-agility [Change from baseline speed agility at eight weeks]

    4x10m speed agility test (Alpha battery)

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Health Sciences, Universidad Pública de Navarra Pamplona Navarra Spain 31008

Sponsors and Collaborators

  • Universidad Pública de Navarra

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Idoia Labayen, Principal Investigator, Universidad Pública de Navarra
ClinicalTrials.gov Identifier:
NCT03479658
Other Study ID Numbers:
  • PI-018/17
First Posted:
Mar 27, 2018
Last Update Posted:
Oct 3, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Idoia Labayen, Principal Investigator, Universidad Pública de Navarra
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 3, 2018