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Clinical Trials/NCT06431230
NCT06431230Active, not recruitingNot Applicable

Dose-response Relationship and High-intensity Interval Training Effects During Physical Education Lesson on Health Markers in Adolescents

Wroclaw University of Health and Sport Sciences2 sites in 1 country600 target enrollmentStarted: February 15, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
600
Locations
2
Primary Endpoint
diastolic blood pressure (DBP)

Study Overview

Brief Summary

There are experimental evidences of the importance of high intensity exercises in health outcomes improvement. However, there are limited knowledge about possibility to affect health outcomes in adolescents through exercises programs introduced into physical education (PE) lesson. Moreover, there is lack of the studies identifying people who do not respond to stimuli, as well as examining potential determinants of non-responsiveness. Thirdly, there are no studies examining the modification of exercise dose that should be reflected in the response in such individuals.

Aim of this human experiment is to examine the effects of one cycle of 8-weeks high-intensity interval training (HIIT) implemented in physical education lesson on: (1) body composition (proportions of the body fat to the body muscles), (2) resting blood pressure, (3) physical efficiency.

Study are conducted for two years (two cycles). Each year 300 students of two secondary schools, are involved in project: 15-16-year-olds in first year, 18-19-year-olds in second year. Students are divided in experimental groups -performing 8-weeks (twice a week) cycle of HIIT implemented into PE lesson, and the control groups - students following a typical PE programme. Each cycle consists of two parts. First part is related to the 8 weeks of HIIT training, while second part is related to the dose-expose study.

All participants are examined during project before (Pre), after (Post) and Follow-Up intervention. Second part is planned after a break of several months. Persons who do not respond to the exercise stimulus in the first part will follow individually modified programmes. They will be measured before and after this additional training.

To examine the assumed HIIT-induced changes in participants the investigators will apply: (1) anthropometric measurements: body height and weight, and BMI will be calculated, (2) body mass composition (fat and muscle mass), (3) resting blood pressure, (4) beep test which is field motor specific test to assess physical efficiency.

The results of this project will help to answer the fundamental questions about HIIT induced morphological and physiological effects in adolescents, what is important from scientific and public health point of view. Particularly, in view of the growing pandemic of obesity, common elevated blood pressure and steadily declining physical fitness in children and adolescents.

Detailed Description

I. Background Prevalence of overweight and obesity is well documented in the literature. This applies to both adults and the elderly, but increasingly also to children and school-age youth. Similar to adipose tissue, there is a constant increase in the percentage of young individuals with elevated blood pressure. Moreover, children and adolescents are steadily decreasing their physical efficiency. All these characteristics serve as indicators of overall health, defined as health-related fitness (HRF). Measurements represent the health potential that adolescents bring into adulthood, what is closely related to their efficient functioning in family and professional life.

In the battle against lifestyle diseases during adolescence, there is a growing trend towards implementing intense short-term efforts. Evidence from numerous studies confirms the effectiveness of High-Intensity Interval Training (HIIT) in reducing body weight, improving body mass index (BMI), reducing body fat, and lowering resting blood pressure. Due to the reluctance of children and adolescents to engage in physical activity during leisure time, there is an increasing systemic implementation of HIIT in physical education classes to ensure widespread physical exercise among students.

A separate issue is the lack of response to exercise in some individuals (so-called non-responders). There are few studies that attempt to find the optimal exercise dose to elicit a response in as many participants as possible, ideally in all participants (dose-response relationship). However, the effectiveness of training based on the duration of exercise and rest intervals, the type of exercises (endurance, resistance, etc.), and exercise intensity is still unknown.

II. Research Project Objectives

Therefore, the aims of this research are twofold:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
14 Years to 20 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • For all participants:
  • active student of school enrolled in project,
  • age 14-16 or 18-20,
  • active student of 1st class in the school (for participants 14-16 years of age) or 4th class in the school (for participants 18-20 years of age),
  • active participation in PE lessons (no medical or other exemption from lessons),
  • no medical contraindications
  • signed informed consent (parent/legal guardian) in case of under-age participant).

Exclusion Criteria

  • For all participants:
  • commitment to structured sports training
  • injury less than 3 months prior to the intervention

Outcomes

Primary Outcomes

diastolic blood pressure (DBP)

Time Frame: Pre-HIIT, up to 24 weeks

resting blood pressure parameter, this measurement is to evaluate the potential effect of the intervention on blood pressure, particularly the the potential to reduce resting blood pressure in people with raised blood pressure (prehypertension)

physical efficiency (CRF)

Time Frame: Pre-HIIT, up to 24 weeks

cardiorespiratory fitness (CRF), evaluate the potential effect of intervention on aerobic capacity; CRF is assessed with Multistage Fitness Test (MFT), and evaluates maximum rate of oxygen intake (VO2max). Participants perform continuous 20-metre shuttle runs, with the individual having to reach the opposite end of the 20-metre grid before the next sound signal. The time between signals decreases with each minute, forcing individuals to increase their running speed. Initial running velocity is of 8.5 km/hr and increases the speed by 0.5 km/hr each minute thereafter. The test is comprised of 23 levels. The result the participant achieved (the speed on the last level before the end) is transformed and the final outcome is maximum rate of oxygen intake. However, VO2max is calculated from formula: VO₂ max = -27.4 + 6.0 (speed); where speed is determined by the level achieved by the participant before he/she is withdrawn from the test.

skeletal body muscle mass (SMM)

Time Frame: Pre-HIIT, up to 24 weeks

the body composition measurement with electronic bio-impedance tool (InBody); this measurement is to evaluate the potential of the intervention in muscle mass increase

systolic blood pressure (SBP)

Time Frame: Pre-HIIT, up to 24 weeks

resting blood pressure parameter, this measurement is to evaluate the potential effect of the intervention on blood pressure, particularly the the potential to reduce resting blood pressure in people with raised blood pressure (prehypertension)

body fat weight (BF)

Time Frame: Pre-HIIT, up to 24 weeks

tthe body composition measurement with electronic bio-impedance tool (InBody); this measurement is to evaluate the potential of the intervention in body fat reduction

Secondary Outcomes

  • body weight (BW)(Pre-HIIT, up to 24 weeks)
  • body water (BWat)(Pre-HIIT, up to 24 weeks)
  • body height (BH)(Pre-HIIT,up to 24 weeks)
  • sitting height (SBH)(Pre-HIIT, up to 24 weeks)
  • social-economic situation(Pre-HIIT)
  • perceived attractiveness of lessons(within 10 minutes after each cycle of HIIT)
  • physical activity(Pre-HIIT)
  • fatigue perception(within 10 minutes after each cycle of HIIT)
  • dietary intake(Pre-HIIT)

Investigators

Sponsor
Wroclaw University of Health and Sport Sciences
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jaroslaw Domaradzki

PhD, Associate Professor

Wroclaw University of Health and Sport Sciences

Study Sites (2)

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