- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05544370
H2 Physical Education: Promoting Cardiometabolic Health by 2 High Intensity Intervallic Training Protocol, Twice a Week at Physical Education (H2PE)
Several risk factors associated with cardiovascular disease could be prevented or treated by means of physical activity from childhood. Among the physical exercise programs for the improvement of these variables we can highlight high-intensity interval training. However, most of these studies have been carried out on overweight or obese athletes or schoolchildren and existing protocols on high intensity intervallic training are different. The main objective of the present research is to compare two high-intensity intervallic training protocols on body composition, heart rate, blood pressure, lipid profile, blood glucose, cardiovascular fitness, strength, quality of life, physical activity, enjoyment of physical activity and accident proneness in adolescents. The present investigation will be elaborated by a randomized-control trial design, with 2 experimental groups and a control group (CG). In each experimental groups a different protocol of high-intensity interval training is applied.
It is assessed cardiovascular capacity and strength. Body composition is assessed. Heart rate and blood pressure were also recorded. Lipid profile and blood glucose were obtained by blood sampling. Quality of life, sedentary and physical activity lifestyle, enjoyment of physical activity and Psychoeducational factors determining accident process are assessed.
Study Overview
Status
Conditions
Detailed Description
Cardiovascular diseases are the leading cause of death today. These have been inversely correlated with physical activity and fitness in adults, children and adolescents. In this sense, certain risk factors associated with cardiovascular disease could be prevented or treated by means of physical activity from childhood. Traditionally, the benefits of physical activity on cardiovascular markers and physical fitness in children and adolescents have been described in research conducted with traditional aerobic exercise programs. Among the physical exercise programs for the improvement of these variables we can highlight high-intensity interval training. However, most of these studies have been carried out on overweight or obese athletes or schoolchildren. On the other hand, the existing protocols on high intensity intervallic training are different, there have been intensive and extensive protocols. Likewise, the investigations do not usually control the real intensity of work and it has been described that in most cases the participants do not manage to reach the described intensity, which indicates that they are not working at the level that is considered or they are working with an intensity of an extensive protocol while the duration is of an intensive protocol. In this sense, the objective of the present research is a) to know the effect of high intensity intervallic training on body composition, heart rate, blood pressure, lipid profile, glycemia, cardiovascular capacity, strength, quality of life, physical activity, enjoyment of physical activity and accident proneness in adolescents and b) to compare two high-intensity intervallic training protocols on body composition, heart rate, blood pressure, lipid profile, blood glucose, cardiovascular fitness, strength, quality of life, physical activity, enjoyment of physical activity and accident proneness in adolescents.
The present investigation will be elaborated by a randomized-control trial design, with 2 experimental groups and a control group (CG); with pre-test and post-test. Each experimental groups performance differences protocol of high-intensity interval training.
The inclusion criteria will be: a) being in Compulsory Secondary Education; b) not presenting any musculoskeletal, neurological, cardiological, metabolic, rheumatic or previous history of spinal pathologies or with previous treatment; c) be active in the sessions of Physical Education.
Primary outcome measure are cardiovascular capacity, strength of upper limbs and strength of lower limbs. These variables are tested with "Course Navette test", handgrip dynamometry and long jump test, respectively.
Secondary outcome measure are body composition and its assessed by height, weight, waist circumference, fat percentage, hydration, muscle mass, bone weight and visceral fat. The body mass index will be obtained by recording weight and height (BMI = Weight (kg) / height (cm) 2). Heart rate and blood pressure were also recorded. Lipid profile (high density lipoproteins, low density lipoproteins and triglycerides) and blood glucose were obtained by blood sampling. Quality of life are assessed through the "Kidscreen-27 questionnaire". The sedentary lifestyle as well as the level of physical activity will be evaluated through the Adolescent International Physical Activity Questionnaire (IPAQ).
The enjoyment of physical activity and a questionnaire on Psychoeducational factors determining accident proneness in adolescents were assessed.
Intensity was assessed during all sessions by means of a heart rate monitor for each adolescent.
The type of activity used to develop the training was continuous running. After the usual warm-up in physical education classes, one of the two high-intensity interval training protocols was applied. Both have the same work time but distributed in different ways and with different intensities.
The intensive high intensity intervallic training group performs 6 sets of 60 seconds of work and 60 seconds of rest. During the first two weeks we work at an intensity of 80-85% of the reserve heart rate during the work phase and 50-55% of the reserve heart rate during the rest time. In weeks 3 and 4 the intensity in the work phase is increased by 5%, reaching from the fifth week onwards a work intensity of 95-95% of the reserve heart rate.
The extensive high-intensity intervallic training group performs 3 sets of 120 seconds of work and 120 seconds of rest at an intensity of 70-75% of the reserve heart rate during the work phase and an intensity of 50-55% of the reserve heart rate during the rest phase. In weeks 3 and 4 the intensity in the work phase is increased by 5%, reaching from the fifth week onwards a work intensity of 80-85% of the reserve heart rate.
The program duration is 8 weeks and the frequency of intervention is 2 sessions per week.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Murcia, Spain, 30010
- Noelia G González-Gálvez, PhD.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- being in Compulsory Secondary Education
- be active in the sessions of Physical Education
Exclusion Criteria:
- presenting any musculoskeletal, neurological, cardiological, metabolic, rheumatic or previous history of spinal pathologies or with previous treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intensive high intensity intervallic training group
The intensive high intensity intervallic training group performs 6 sets of 60 seconds of work and 60 seconds of rest.
During the first two weeks we work at an intensity of 80-85% of the reserve heart rate during the work phase and 50-55% of the reserve heart rate during the rest time.
In weeks 3 and 4 the intensity in the work phase is increased by 5%, reaching from the fifth week onwards a work intensity of 95-95% of the reserve heart rate.
The program duration is 8 weeks and the frequency of intervention is 2 sessions per week.
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The intensive high intensity intervallic training group performs 6 sets of 60 seconds of work and 60 seconds of rest.
During the first two weeks we work at an intensity of 80-85% of the reserve heart rate during the work phase and 50-55% of the reserve heart rate during the rest time.
In weeks 3 and 4 the intensity in the work phase is increased by 5%, reaching from the fifth week onwards a work intensity of 95-95% of the reserve heart rate.
The program duration is 8 weeks and the frequency of intervention is 2 sessions per week.
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|
Experimental: Extensive high-intensity intervallic training group
The extensive high-intensity intervallic training group performs 3 sets of 120 seconds of work and 120 seconds of rest at an intensity of 70-75% of the reserve heart rate during the work phase and an intensity of 50-55% of the reserve heart rate during the rest phase.
In weeks 3 and 4 the intensity in the work phase is increased by 5%, reaching from the fifth week onwards a work intensity of 80-85% of the reserve heart rate.
The program duration is 8 weeks and the frequency of intervention is 2 sessions per week.
|
The extensive high-intensity intervallic training group performs 3 sets of 120 seconds of work and 120 seconds of rest at an intensity of 70-75% of the reserve heart rate during the work phase and an intensity of 50-55% of the reserve heart rate during the rest phase.
In weeks 3 and 4 the intensity in the work phase is increased by 5%, reaching from the fifth week onwards a work intensity of 80-85% of the reserve heart rate.
The program duration is 8 weeks and the frequency of intervention is 2 sessions per week.
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No Intervention: Control group
The control group will carry out their usual physical education classes which consist of games, jumping, moving, balance and different sports.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change to baseline to 8 week of Cardiovascular capacity
Time Frame: Two times. Baseline and 8 week later
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Cardiovascular capacity is evaluated by means of the Course Navete test.
A high value in this test refers to a better cardiovascular capacity.
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of Manual clamping force
Time Frame: Two times. Baseline and 8 week later
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Manual grip strength is assessed by means of dynamometry.
The higher the value in this test, the greater the manual grip strength.
It is recorded in kilograms.
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of Long jump
Time Frame: Two times. Baseline and 8 week later
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The long jump is recorded by means of a mobile application.
A higher value in this test reflects greater strength in the lower extremities.
It is recorded in centimeters.
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Two times. Baseline and 8 week later
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change to baseline to 8 week of Height
Time Frame: Two times. Baseline and 8 week later
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The size of the subject will be measured in centimeters.
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of Weight
Time Frame: Two times. Baseline and 8 week later
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The Weight of the subject will be measured in kilograms.
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of Waist circumference
Time Frame: Two times. Baseline and 8 week later
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The waist circumference of the subject will be measured in centimeters.
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of Fat percentage
Time Frame: Two times. Baseline and 8 week later
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The percentage of fat was assessed by bioimpedance.
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of Hydration percentage
Time Frame: Two times. Baseline and 8 week later
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The hydratation was assessed by bioimpedance.
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of Muscle mass
Time Frame: Two times. Baseline and 8 week later
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The muscle mass was assessed by bioimpedance.
It was register in kilograms.
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of Bone weight
Time Frame: Two times. Baseline and 8 week later
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The bone weight was assessed by bioimpedance.
It was register in kilograms.
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of Visceral fat
Time Frame: Two times. Baseline and 8 week later
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The visceral fat was assessed by bioimpedance.
It was register in kilograms.
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of Heart rate
Time Frame: Two times. Baseline and 8 week later
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The heart rate is taken under a blood pressure and heart rate device and the value is given in number of beats per minute.
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of systolic and diastolic Blood pressure
Time Frame: Two times. Baseline and 8 week later
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Blood pressure (systolic and diastolic) is taken under a blood pressure and heart rate measuring device and the value is given in number of millimeters of mercury.
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of Blood glucose
Time Frame: Two times. Baseline and 8 week later
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Blood glucose lipoproteins is analyzed by blood extraction.
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of High density lipoproteins
Time Frame: Two times. Baseline and 8 week later
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High-density lipoproteins is analyzed by blood extraction.
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of Low density lipoproteins
Time Frame: Two times. Baseline and 8 week later
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Low-density lipoproteins is analyzed by blood extraction.
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of Triglycerides
Time Frame: Two times. Baseline and 8 week later
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Triglycerides is analyzed by blood extraction.
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of Quality of life level
Time Frame: Two times. Baseline and 8 week later
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Quality of life was assessed through the "Kidscreen-27 questionnaire" (assess health and subjective well-being in children and adolescents).
This questionnaire report a score on a scale, with 5 option (never, a little, often, very often and always).
The minimum value is 0 up to 100.
A higher score on this test reflects a higher quality of life level.
Higher score mean a better outcome.
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of Sedentary and physical activity lifestyle
Time Frame: Two times. Baseline and 8 week later
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The sedentary lifestyle as well as the level of physical activity will be evaluated through the Adolescent International Physical Activity Questionnaire (IPAQ).
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Two times. Baseline and 8 week later
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Change to baseline to 8 week of Enjoyment of physical activity
Time Frame: Two times. Baseline and 8 week later
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The enjoyment of physical activity was measure by a questionaire. This questionnaire report a score on a scale, with 5 option (strongly disagree, somewhat disagree, neutral, somewhat agree and strongly agree). The minimum value is 0 up to 100. A higher score on this test reflects a higher enjoyment. Higher score mean a better outcome. |
Two times. Baseline and 8 week later
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Risk of Accident level
Time Frame: 8 week
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Psychoeducational factors determining accident proneness in adolescents were assessed by questionaire.
A higher score on this test reflects a higher risk of an adolescent accident.
The questionnaire is composed of 4 factors.
Factor 1. Perceived competence (from 8 to 48 points); Factor 2. Factor 3. Competitiveness (from 4 to 24 points), Factor 4. Risk-taking (from 4 to 24 points); and Factor 5. A higher score mean a high point in the factor.
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8 week
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Collaborators and Investigators
Investigators
- Principal Investigator: NOELIA GONZALEZ GALVEZ, PhD, UCAM
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UCMurcia-H2PE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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