Dose-effect of HIIT on Cardiovascular Health of Children

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

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.

Study Overview

• Status: Completed
• Conditions: Adiposity; Cardiovascular Diseases Risk
• Intervention / Treatment: Behavioral: High intensity interval training; Behavioral: Nutritional education

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Department of Health Sciences, Universidad Pública de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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Exclusion Criteria:

• Children with medical condition that limits physical activity

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cardiorespiratory fitness	20m shuttle run test (Alpha battery)	Change from baseline cardiorespiratory fitness at eight weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body fat	Body fat percent measured by bioimpedance	Change from baseline body fat at eight weeks
Change in Ankle-brachial index	Automated simultaneous blood pressure measurement	Change from baseline Ankle-brachial index at eight weeks
Change in Dietary habits	Food frequency questionnaire and 24h recall	Change from baseline Dietary habits at eight weeks
Change in Muscular strength	Handgrip strength and long jump (Alpha battery)	Change from baseline Muscular strength at eight weeks
Change in speed-agility	4x10m speed agility test (Alpha battery)	Change from baseline speed agility at eight weeks

Collaborators and Investigators

• Sponsor: Universidad Pública de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2018
• Primary Completion (Actual): June 20, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2018
• Last Update Submitted That Met QC Criteria: October 2, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: children; blood pressure; adiposity; cardiovascular; fitness; HIIT; school; nutritional education; Dose-effect
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Cardiovascular Diseases; Obesity
• Other Study ID Numbers: PI-018/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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