NCT06431230

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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

May 10, 2024

Last Update Submit

July 24, 2024

Conditions

Keywords

high-intensity interval trainingadolescencebody compositionresting blood pressureresponders and non-respondersdose-response

Outcome Measures

Primary Outcomes (5)

  • body fat weight (BF)

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

    Pre-HIIT, up to 24 weeks

  • skeletal body muscle mass (SMM)

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

    Pre-HIIT, up to 24 weeks

  • systolic blood pressure (SBP)

    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)

    Pre-HIIT, up to 24 weeks

  • diastolic blood pressure (DBP)

    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)

    Pre-HIIT, up to 24 weeks

  • physical efficiency (CRF)

    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.

    Pre-HIIT, up to 24 weeks

Secondary Outcomes (9)

  • body height (BH)

    Pre-HIIT,up to 24 weeks

  • body weight (BW)

    Pre-HIIT, up to 24 weeks

  • body water (BWat)

    Pre-HIIT, up to 24 weeks

  • sitting height (SBH)

    Pre-HIIT, up to 24 weeks

  • social-economic situation

    Pre-HIIT

  • +4 more secondary outcomes

Study Arms (4)

Standard HIIT Experimental Group (SH-EG)

EXPERIMENTAL

SH-EG - Standard HIIT Experimental Group, participants who will perform typical high-intensity interval training

Behavioral: standard high-intensity interval training

Standard HIIT control group (SH-CG)

NO INTERVENTION

SH-CG - Standard HIIT Control Group, participants that will not perform the HIIT cycles

Plyometric HIIT Experimental Group (PH-EG)

EXPERIMENTAL

PH-EG - Plyometric HIIT Experimental Group, participants who will perform plyometric high-intensity interval training

Behavioral: plyometric high-intensity interval training

Plyometric HIIT Control Group (PH-CG)

NO INTERVENTION

PH-CG - Plyometric HIIT Control Group, participants that will not perform the HIIT cycles

Interventions

The project will use an intensive intermittent exercise intervention according to the high-intensity interval training programme. The programme will be implemented during physical education lessons. It involves 4 minutes of exercise in a structure of 20 seconds of intense effort and 10 seconds of rest, for a total of 8 cycles. It will be repeated twice a week (in two PE lessons) for 8 weeks. It is based on the standard physical exercises: squats, push-ups, sit-ups, toe-touches, mountain climber, jumping jacks, standing abs twist and squat to side.

Also known as: St-HIIT
Standard HIIT Experimental Group (SH-EG)

The project will use an intensive intermittent exercise intervention according to the high-intensity interval training programme. The programme will be implemented during physical education lessons. It involves 4 minutes of exercise in a structure of 20 seconds of intense effort and 10 seconds of rest, for a total of 8 cycles. It will be repeated twice a week (in two PE lessons) for 8 weeks. However, there is a difference, comparing to the St-HIIT, related to different exercises used in protocol. This kind of HIIT programme will be based on plyometric exercises: jumping jacks, skip A, skip C, jumps back into a push-up position and returns to the squat position, throwing the legs out of support and jumping out, jumping out of a squat.

Also known as: Pl-HIIT
Plyometric HIIT Experimental Group (PH-EG)

Eligibility Criteria

Age14 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wroclaw University of Health and Sport Sciences

Wroclaw, Dolny Śląsk, 51-612, Poland

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jarosław Domaradzki, PhD

    Wroclaw University of Health and Sport Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Associate Professor

Study Record Dates

First Submitted

May 10, 2024

First Posted

May 28, 2024

Study Start

February 15, 2024

Primary Completion

October 1, 2024

Study Completion

April 15, 2025

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations