Hematologic TestNCT07046520
Effects of HIIT on Plasma Volume and Aerobic Capacity in Obese Adolescent Girls
A study testing High intensity interval training in people with Hematologic Test, run by High Institute of Sports and Physical Education of Kef at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 17 years, women only
- Conditions the study is for
- Hematologic Test
- What is being tested?
- High intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTunisia
- Study dates
- 9 Dec 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Females.
- Aged between 15 and 17 years.
- BMI greater than or equal to the 95th percentile for their age.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
High Institute of Sports and Physical Education of Kef
El Kef, Boulifa, 7100
About this study
Official title: Effects of High-Intensity Interval Training on Plasma Volume, Muscle Damage, and Aerobic Performance in Overweight Adolescent Females
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.
Read the detailed description
Obesity during adolescence is linked to adverse changes in body composition, aerobic fitness, and blood health. High-intensity interval training (HIIT) is a promising strategy to improve these outcomes. However, its effects on hematological markers, plasma volume, and muscle damage in overweight/obese adolescent girls remain unclear. This study aimed to investigate the effects of HIIT on body composition, hematological parameters, plasma volume variations (PVV), muscle damage markers, and aerobic capacity in this population.Twenty-eight overweight/obese girls (16.21±0.92) were randomly assigned to a HIIT group (n=14) or control group (n=14). The 10-week HIIT protocol consisted of 4×6×15s running at 90-105% maximal aerobic speed (MAS) with 15s of active recovery at 50% MAS (3 sessions/week). Pre/post assessments included body composition, hematological markers, muscle damage markers, and aerobic fitness. Plasma volume was estimated post-intervention in both group.
- Conditions
- Hematologic Test
- Being tested
- High intensity interval training
- Keywords
- Obesity, High-Intensity Interval Training, Adolescent Girls, Creatine Kinase, Plasma Volume Variation, Aerobic Capacity, Erythrocytes
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: High intensity interval training |
| Control group | No intervention | No training intervention was intended for the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: At baseline and at week 11 (end of intervention period).
Height
Height (m) was determined using a standard stadiometer (Holtain Ltd., UK).
Measured: At baseline
Body fat
Body fat (%) was recorded using an electronic scale (Tanita BC-533, Tokyo, Japan).
Measured: 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).
Measured: 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.
Measured: At baseline and at week 11 (end of intervention period).
Maximal aerobic speed
Maximal aerobic speed was determined using the Vameval test (Cazorla,1990).
Measured: 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).
Measured: 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).
Measured: At baseline and at week 11 (end of intervention period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start9 Dec 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic TestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- High Institute of Sports and Physical Education of Kef
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wissal Abassi, High Institute of Sports and Physical Education of Kef
- Investigators
- Wissal abassi, Dr, Principal investigator, Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046520
- Sponsor's protocol ID
- HIIT-ADO-2025-TN
- Status last verified
- Dec 2024
- First submitted
- 23 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For confidentiality reasons, all data from this study are available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Intensity Interval Training on Plasma Volume, Muscle Damage, and Aerobic Performance in Overweight Adolescent Females
- ClinicalTrials.gov ID
- NCT07046520
- Acronym / sponsor ID
- HIIT-ADO-2025-TN
- Conditions
- Hematologic Test
- Keywords
- Obesity, High-Intensity Interval Training, Adolescent Girls, Creatine Kinase, Plasma Volume Variation, Aerobic Capacity, Erythrocytes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- High Institute of Sports and Physical Education of KefUniversity, hospital or other
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity during adolescence is linked to adverse changes in body composition, aerobic fitness, and blood health. High-intensity interval training (HIIT) is a promising strategy to improve these outcomes. However, its effects on hematological markers, plasma volume, and muscle damage in overweight/obese adolescent girls remain unclear. This study aimed to investigate the effects of HIIT on body composition, hematological parameters, plasma volume variations (PVV), muscle damage markers, and aerobic capacity in this population.Twenty-eight overweight/obese girls (16.21±0.92) were randomly assigned to a HIIT group (n=14) or control group (n=14). The 10-week HIIT protocol consisted of 4×6×15s running at 90-105% maximal aerobic speed (MAS) with 15s of active recovery at 50% MAS (3 sessions/week). Pre/post assessments included body composition, hematological markers, muscle damage markers, and aerobic fitness. Plasma volume was estimated post-intervention in both group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training group | Experimental | Behavioral: High intensity interval trainingHigh-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. |
| Control group | No intervention | –No training intervention was intended for the control group. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Females.
- Aged between 15 and 17 years.
- BMI greater than or equal to the 95th percentile for their age.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity interval trainingHIIT 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. | Behavioural | High-intensity interval training group |
Primary outcome
Erythrocytes
Time frame: At baseline and at week 11 (end of intervention period).
Blood levels of erythrocytes were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany).
Hemoglobin
Time frame: At baseline and at week 11 (end of intervention period).
Blood levels of hemoglobin were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany).
Hematocrit
Time frame: At baseline and at week 11 (end of intervention period).
Blood levels of hematocrit were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany).
Mean corpuscular volume
Time frame: At baseline and at week 11 (end of intervention period).
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).
Mean corpuscular hemoglobin content
Time frame: At baseline and at week 11 (end of intervention period).
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).
Mean hemoglobin concentration
Time frame: At baseline and at week 11 (end of intervention period)
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).
Creatine kinase
Time frame: At baseline and at week 11 (end of intervention period).
Serum concentrations of creatine kinase are measured from a blood sample (5 ml) using a Beckman Coulter AU480 Chemistry Analyzer (France).
Lactate dehydrogenase
Time frame: At baseline and at week 11 (end of intervention period).
Serum concentrations of lactate dehydrogenase are measured from a blood sample (5 ml) using a Beckman Coulter AU480 Chemistry Analyzer (France).
Plasma volume variations
Time frame: 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] ).
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.
Body weight
Time frame: At baseline and at week 11 (end of intervention period).
Body weight (kg) was recorded , with barefoot and lightly dressed subjects, using an electronic scale (Tanita BC-533, Tokyo, Japan).
Height
Time frame: At baseline
Height (m) was determined using a standard stadiometer (Holtain Ltd., UK).
Body fat
Time frame: At baseline and at week 11 (end of intervention period)
Body fat (%) was recorded using an electronic scale (Tanita BC-533, Tokyo, Japan).
Body mass index
Time frame: At baseline and at week 11 (end of intervention period).
Body mass index (kg/m²) was calculated as weight (kg) divided by height squared (m²).
Waist circumference
Time frame: At baseline and at week 11 (end of intervention period).
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.
Maximal aerobic speed
Time frame: At baseline and at week 11 (end of intervention period).
Maximal aerobic speed was determined using the Vameval test (Cazorla,1990).
Maximal oxygen consumption (VO2max)
Time frame: At baseline and at week 11 (end of intervention period).
Maximal oxygen consumption (VO2max) were determined using the Vameval test (Cazorla,1990).
Maximal heart rate (HRmax)
Time frame: At baseline and at week 11 (end of intervention period).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No. For confidentiality reasons, all data from this study are available upon request.
Related trials for Hematologic Test
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wissal abassi, Dr principal investigator
Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval training in people with Hematologic Test, run by High Institute of Sports and Physical Education of Kef at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythrocytes (time frame: At baseline and at week 11 (end of intervention period).). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.