NCT07046520

Brief Summary

The goal of this clinical trial is to investigate the impact of high-intensity interval training (HIIT) program on body composition, hematological parameters, plasma volume variations (PVV), muscle damage markers, and aerobic capacity in overweight/obese adolescent girls. The main question it aims to answer is: Does HIIT reduce risk factors associated obesity diseases by modulating body composition and hematological parameters and increasing PVV? Researchers will compare HIIT (designed to the experimental group) to nontraining intervention (designed to the control group) to see if the training program works to enhance physiological health and reduce risk factors associated with obesity in this population. Participants in the experimental (HIIT group) group will: underwent HIIT at 90-105% maximal aerobic speed (MAS), three times a week. Participants in control group will : not perform any physical training and maintain their usual daily activities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 9, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
Last Updated

July 4, 2025

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

June 23, 2025

Last Update Submit

July 1, 2025

Conditions

Keywords

ObesityHigh-Intensity Interval TrainingAdolescent GirlsCreatine KinasePlasma Volume VariationAerobic CapacityErythrocytes

Outcome Measures

Primary Outcomes (17)

  • Erythrocytes

    Blood levels of erythrocytes were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany).

    At baseline and at week 11 (end of intervention period).

  • Hemoglobin

    Blood levels of hemoglobin were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany).

    At baseline and at week 11 (end of intervention period).

  • Hematocrit

    Blood levels of hematocrit were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany).

    At baseline and at week 11 (end of intervention period).

  • Mean corpuscular volume

    Blood levels of mean corpuscular volume were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany).

    At baseline and at week 11 (end of intervention period).

  • Mean corpuscular hemoglobin content

    Blood levels of mean corpuscular hemoglobin content were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany).

    At baseline and at week 11 (end of intervention period).

  • Mean hemoglobin concentration

    Blood levels of mean hemoglobin concentration were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany).

    At baseline and at week 11 (end of intervention period)

  • Creatine kinase

    Serum concentrations of creatine kinase are measured from a blood sample (5 ml) using a Beckman Coulter AU480 Chemistry Analyzer (France).

    At baseline and at week 11 (end of intervention period).

  • Lactate dehydrogenase

    Serum concentrations of lactate dehydrogenase are measured from a blood sample (5 ml) using a Beckman Coulter AU480 Chemistry Analyzer (France).

    At baseline and at week 11 (end of intervention period).

  • Plasma volume variations

    Plasma volume variations (PVV) was calculated based on measured hematocrit (Ht) and hemoglobin (Hb) values according to the method developed by Costill and Fink (1974). %PVV=100 ×\[(HbA/HbB) ×(100 - HtB) / (100 - HtA)\] - 1, where 0 is the value measured before training program and 1 is the value measured after training program.

    Plasma volume variations (PVV) was calculated at week 11 (end of intervention period) under two conditions (High intensity interval training and No training intervention [control group] ).

  • Body weight

    Body weight (kg) was recorded , with barefoot and lightly dressed subjects, using an electronic scale (Tanita BC-533, Tokyo, Japan).

    At baseline and at week 11 (end of intervention period).

  • Height

    Height (m) was determined using a standard stadiometer (Holtain Ltd., UK).

    At baseline

  • Body fat

    Body fat (%) was recorded using an electronic scale (Tanita BC-533, Tokyo, Japan).

    At baseline and at week 11 (end of intervention period)

  • Body mass index

    Body mass index (kg/m²) was calculated as weight (kg) divided by height squared (m²).

    At baseline and at week 11 (end of intervention period).

  • Waist circumference

    Waist circumference (cm) was measured to the nearest 0.1 cm using a non-deformable anthropometric tape, placed horizontally at the midpoint between the inferior margin of the last palpable rib and the superior border of the iliac crest, with the participant standing upright and breathing normally.

    At baseline and at week 11 (end of intervention period).

  • Maximal aerobic speed

    Maximal aerobic speed was determined using the Vameval test (Cazorla,1990).

    At baseline and at week 11 (end of intervention period).

  • Maximal oxygen consumption (VO2max)

    Maximal oxygen consumption (VO2max) were determined using the Vameval test (Cazorla,1990).

    At baseline and at week 11 (end of intervention period).

  • Maximal heart rate (HRmax)

    Maximal heart rate maximum (HRmax) was recorded at the final stage of the Vameval test (Cazorla,1990) using a Polar heart rate monitor (Polar S810, Kempele, Finland).

    At baseline and at week 11 (end of intervention period).

Study Arms (2)

High-intensity interval training group

EXPERIMENTAL

High-intensity interval training group performed four series of 15-second runs at 90-105% of the maximal aerobic speed (MAS) interspersed with 15 seconds of active recovery at 5O% MAS.

Behavioral: High intensity interval training

Control group

NO INTERVENTION

No training intervention was intended for the control group.

Interventions

HIIT protocol was performed three times per week over a 10-week period, totaling 30 sessions. HIIT sessions included: (1) a standardized warm-up of five minutes of continuous jogging at 50%MAS, followed by five minutes of dynamic mobility and activation drills such as high-knee skips, high-knee running, and butt kicks. (2) a HIIT training session, consisted of four series of 15-second runs at 90-105% of the maximal aerobic speed (MAS) interspersed with 15 seconds of active recovery and (3) a cool-down of five minutes of static stretching.

High-intensity interval training group

Eligibility Criteria

Age15 Years - 17 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Females.
  • Aged between 15 and 17 years.
  • BMI greater than or equal to the 95th percentile for their age.

You may not qualify if:

  • Pharmacological treatments or medical conditions that could interact with the protocol (e.g.,hypertension, diabetes, cardiac, orthopedic, neuromuscular, or neurological disorders).
  • Hormone replacement therapy or therapies for obesity.
  • Irregular menstrual cycle.
  • Restrictive diet or use of dietary supplements or engagement in any structured physical training either currently or during the previous three months.
  • Withdrawal of consent.
  • Non-compliance with study procedures.
  • Insufficient data for analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

High Institute of Sports and Physical Education of Kef

El Kef, Boulifa, 7100, Tunisia

Location

MeSH Terms

Conditions

Obesity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Wissal abassi, Dr

    Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 1, 2025

Study Start

December 9, 2024

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

July 4, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

For confidentiality reasons, all data from this study are available upon request.

Locations