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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05544370
Other study ID # UCMurcia-H2PE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 12, 2022
Est. completion date December 30, 2022

Study information

Verified date May 2024
Source Universidad Católica San Antonio de Murcia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date December 30, 2022
Est. primary completion date October 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 14 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
Extensive high-intensity intervallic training
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.

Locations

Country Name City State
Spain Noelia G González-Gálvez, PhD. Murcia

Sponsors (1)

Lead Sponsor Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change to baseline to 8 week of Cardiovascular capacity Cardiovascular capacity is evaluated by means of the Course Navete test. A high value in this test refers to a better cardiovascular capacity. Two times. Baseline and 8 week later
Primary Change to baseline to 8 week of Manual clamping force 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. Two times. Baseline and 8 week later
Primary Change to baseline to 8 week of Long jump 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. Two times. Baseline and 8 week later
Secondary Change to baseline to 8 week of Height The size of the subject will be measured in centimeters. Two times. Baseline and 8 week later
Secondary Change to baseline to 8 week of Weight The Weight of the subject will be measured in kilograms. Two times. Baseline and 8 week later
Secondary Change to baseline to 8 week of Waist circumference The waist circumference of the subject will be measured in centimeters. Two times. Baseline and 8 week later
Secondary Change to baseline to 8 week of Fat percentage The percentage of fat was assessed by bioimpedance. Two times. Baseline and 8 week later
Secondary Change to baseline to 8 week of Hydration percentage The hydratation was assessed by bioimpedance. Two times. Baseline and 8 week later
Secondary Change to baseline to 8 week of Muscle mass The muscle mass was assessed by bioimpedance. It was register in kilograms. Two times. Baseline and 8 week later
Secondary Change to baseline to 8 week of Bone weight The bone weight was assessed by bioimpedance. It was register in kilograms. Two times. Baseline and 8 week later
Secondary Change to baseline to 8 week of Visceral fat The visceral fat was assessed by bioimpedance. It was register in kilograms. Two times. Baseline and 8 week later
Secondary Change to baseline to 8 week of Heart rate The heart rate is taken under a blood pressure and heart rate device and the value is given in number of beats per minute. Two times. Baseline and 8 week later
Secondary Change to baseline to 8 week of systolic and diastolic Blood pressure 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. Two times. Baseline and 8 week later
Secondary Change to baseline to 8 week of Blood glucose Blood glucose lipoproteins is analyzed by blood extraction. Two times. Baseline and 8 week later
Secondary Change to baseline to 8 week of High density lipoproteins High-density lipoproteins is analyzed by blood extraction. Two times. Baseline and 8 week later
Secondary Change to baseline to 8 week of Low density lipoproteins Low-density lipoproteins is analyzed by blood extraction. Two times. Baseline and 8 week later
Secondary Change to baseline to 8 week of Triglycerides Triglycerides is analyzed by blood extraction. Two times. Baseline and 8 week later
Secondary Change to baseline to 8 week of Quality of life level 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. Two times. Baseline and 8 week later
Secondary Change to baseline to 8 week of Sedentary and physical activity lifestyle The sedentary lifestyle as well as the level of physical activity will be evaluated through the Adolescent International Physical Activity Questionnaire (IPAQ). Two times. Baseline and 8 week later
Secondary Change to baseline to 8 week of Enjoyment of physical activity 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
Secondary Risk of Accident level 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. 8 week
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