NCT05544370

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

September 12, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

September 9, 2022

Last Update Submit

May 7, 2024

Conditions

Keywords

adolescentscardiovascularstrengthhigh intensity interval trainingmetabolic syndromephysical activity

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (18)

  • Change to baseline to 8 week of Height

    Two times. Baseline and 8 week later

  • Change to baseline to 8 week of Weight

    Two times. Baseline and 8 week later

  • Change to baseline to 8 week of Waist circumference

    Two times. Baseline and 8 week later

  • Change to baseline to 8 week of Fat percentage

    Two times. Baseline and 8 week later

  • Change to baseline to 8 week of Hydration percentage

    Two times. Baseline and 8 week later

  • +13 more secondary outcomes

Study Arms (3)

Intensive high intensity intervallic training group

EXPERIMENTAL

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.

Behavioral: Intensive high intensity intervallic training group

Extensive high-intensity intervallic training group

EXPERIMENTAL

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.

Behavioral: Extensive high-intensity intervallic training

Control group

NO INTERVENTION

The control group will carry out their usual physical education classes which consist of games, jumping, moving, balance and different sports.

Interventions

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.

Intensive 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.

Extensive high-intensity intervallic training group

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • being in Compulsory Secondary Education
  • be active in the sessions of Physical Education

You may not qualify if:

  • presenting any musculoskeletal, neurological, cardiological, metabolic, rheumatic or previous history of spinal pathologies or with previous treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Noelia G González-Gálvez, PhD.

Murcia, 30010, Spain

Location

Related Publications (1)

  • Gonzalez-Galvez N, Vaquero-Cristobal R, Macia-Andreu MJ, Garcia-Tascon M, Soler-Marin A, Gallardo-Guerrero AM. Influence of physical fitness components on personality factors and risk perception of children and adolescents: a cross-sectional study. BMJ Open. 2023 Dec 10;13(12):e071995. doi: 10.1136/bmjopen-2023-071995.

MeSH Terms

Conditions

Adolescent BehaviorMetabolic SyndromeMotor Activity

Condition Hierarchy (Ancestors)

BehaviorInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • NOELIA GONZALEZ GALVEZ, PhD

    UCAM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 16, 2022

Study Start

September 12, 2022

Primary Completion

October 30, 2022

Study Completion

December 30, 2022

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations