Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT07046520
Status:
COMPLETED
Last Update Posted:
2025-07-04
First Post:
2025-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of HIIT on Plasma Volume and Aerobic Capacity in Obese Adolescent Girls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Erythrocytes', 'timeFrame': 'At baseline and at week 11 (end of intervention period).', 'description': 'Blood levels of erythrocytes were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany).'}, {'measure': 'Hemoglobin', 'timeFrame': 'At baseline and at week 11 (end of intervention period).', 'description': 'Blood levels of hemoglobin were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany).'}, {'measure': 'Hematocrit', 'timeFrame': 'At baseline and at week 11 (end of intervention period).', 'description': 'Blood levels of hematocrit were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany).'}, {'measure': 'Mean corpuscular volume', 'timeFrame': 'At baseline and at week 11 (end of intervention period).', 'description': '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).'}, {'measure': 'Mean corpuscular hemoglobin content', 'timeFrame': 'At baseline and at week 11 (end of intervention period).', 'description': '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).'}, {'measure': 'Mean hemoglobin concentration', 'timeFrame': 'At baseline and at week 11 (end of intervention period)', 'description': '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).'}, {'measure': 'Creatine kinase', 'timeFrame': 'At baseline and at week 11 (end of intervention period).', 'description': 'Serum concentrations of creatine kinase are measured from a blood sample (5 ml) using a Beckman Coulter AU480 Chemistry Analyzer (France).'}, {'measure': 'Lactate dehydrogenase', 'timeFrame': 'At baseline and at week 11 (end of intervention period).', 'description': 'Serum concentrations of lactate dehydrogenase are measured from a blood sample (5 ml) using a Beckman Coulter AU480 Chemistry Analyzer (France).'}, {'measure': 'Plasma volume variations', 'timeFrame': '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] ).', 'description': '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.'}, {'measure': 'Body weight', 'timeFrame': 'At baseline and at week 11 (end of intervention period).', 'description': 'Body weight (kg) was recorded , with barefoot and lightly dressed subjects, using an electronic scale (Tanita BC-533, Tokyo, Japan).'}, {'measure': 'Height', 'timeFrame': 'At baseline', 'description': 'Height (m) was determined using a standard stadiometer (Holtain Ltd., UK).'}, {'measure': 'Body fat', 'timeFrame': 'At baseline and at week 11 (end of intervention period)', 'description': 'Body fat (%) was recorded using an electronic scale (Tanita BC-533, Tokyo, Japan).'}, {'measure': 'Body mass index', 'timeFrame': 'At baseline and at week 11 (end of intervention period).', 'description': 'Body mass index (kg/m²) was calculated as weight (kg) divided by height squared (m²).'}, {'measure': 'Waist circumference', 'timeFrame': 'At baseline and at week 11 (end of intervention period).', 'description': '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.'}, {'measure': 'Maximal aerobic speed', 'timeFrame': 'At baseline and at week 11 (end of intervention period).', 'description': 'Maximal aerobic speed was determined using the Vameval test (Cazorla,1990).'}, {'measure': 'Maximal oxygen consumption (VO2max)', 'timeFrame': 'At baseline and at week 11 (end of intervention period).', 'description': 'Maximal oxygen consumption (VO2max) were determined using the Vameval test (Cazorla,1990).'}, {'measure': 'Maximal heart rate (HRmax)', 'timeFrame': 'At baseline and at week 11 (end of intervention period).', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'High-Intensity Interval Training', 'Adolescent Girls', 'Creatine Kinase', 'Plasma Volume Variation', 'Aerobic Capacity', 'Erythrocytes'], 'conditions': ['Hematologic Test']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants in control group will : not perform any physical training and maintain their usual daily activities.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females.\n* Aged between 15 and 17 years.\n* BMI greater than or equal to the 95th percentile for their age.\n\nExclusion Criteria:\n\n* Pharmacological treatments or medical conditions that could interact with the protocol (e.g.,hypertension, diabetes, cardiac, orthopedic, neuromuscular, or neurological disorders).\n* Hormone replacement therapy or therapies for obesity.\n* Irregular menstrual cycle.\n* Restrictive diet or use of dietary supplements or engagement in any structured physical training either currently or during the previous three months.\n* Withdrawal of consent.\n* Non-compliance with study procedures.\n* Insufficient data for analysis.'}, 'identificationModule': {'nctId': 'NCT07046520', 'briefTitle': 'Effects of HIIT on Plasma Volume and Aerobic Capacity in Obese Adolescent Girls', 'organization': {'class': 'OTHER', 'fullName': 'High Institute of Sports and Physical Education of Kef'}, 'officialTitle': 'Effects of High-Intensity Interval Training on Plasma Volume, Muscle Damage, and Aerobic Performance in Overweight Adolescent Females', 'orgStudyIdInfo': {'id': 'HIIT-ADO-2025-TN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-intensity interval training group', 'description': '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.', 'interventionNames': ['Behavioral: High intensity interval training']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No training intervention was intended for the control group.'}], 'interventions': [{'name': 'High intensity interval training', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['High-intensity interval training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7100', 'city': 'El Kef', 'state': 'Boulifa', 'country': 'Tunisia', 'facility': 'High Institute of Sports and Physical Education of Kef', 'geoPoint': {'lat': 36.17424, 'lon': 8.70486}}], 'overallOfficials': [{'name': 'Wissal abassi, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'For confidentiality reasons, all data from this study are available upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'High Institute of Sports and Physical Education of Kef', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wissal Abassi', 'investigatorAffiliation': 'High Institute of Sports and Physical Education of Kef'}}}}