- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07773519
Effects of a 10-Week High-Intensity Interval Training Programme on Biochemical and Hormonal Responses in Elite Female Futsal Players
19 sierpnia 2026 zaktualizowane przez: Shimal Hamza Hamad, Soran University
Temporal Dynamics of Biochemical and Hormonal Responses to Interval Training in Elite Female Futsal Players: A 10-Week Longitudinal Analysis Across Menstrual Cycle Phases
This study aims to investigate the biochemical, hormonal, and physiological adaptations to a 10-week periodized high-intensity interval training (HIIT) programme in elite female futsal players.
The study will examine changes in aerobic fitness, blood lactate kinetics, muscle damage biomarkers, inflammatory markers, and reproductive hormones throughout the intervention.
In addition, the influence of menstrual cycle phases on these physiological responses will be evaluated to improve understanding of sex-specific training adaptations and recovery.
The findings are expected to contribute to evidence-based, individualized training and recovery strategies for female futsal athletes.
Przegląd badań
Status
Zakończony
Szczegółowy opis
Female futsal is a high-intensity intermittent team sport requiring substantial aerobic and anaerobic fitness.
Despite increasing participation of women in competitive sports, limited evidence exists regarding the biochemical and hormonal adaptations to structured interval training, particularly across different menstrual cycle phases.
This prospective longitudinal study will recruit 32 elite female futsal players who will participate in a supervised 10-week periodized HIIT programme consisting of lactate threshold training, anaerobic intensification, and sport-specific interval training.
Physiological assessments will include VO₂max, lactate threshold, blood lactate kinetics, creatine kinase, interleukin-6, C-reactive protein, cortisol, and reproductive hormones.
Menstrual cycle phases will be monitored using validated menstrual tracking methods and hormonal confirmation.
Outcomes will be assessed repeatedly throughout the intervention to determine temporal adaptations and the influence of menstrual cycle phase on training responses and recovery.
The results are expected to support individualized, evidence-based training prescription for female athletes.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
32
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Erbil Governorate
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Soran, Erbil Governorate, Irak, 44008
- Soran Univeristy
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Tak
Opis
Inclusion Criteria:
- Female futsal players aged 18-30 years.
- Regular menstrual cycles.
- Participants willing to complete all scheduled testing sessions across the study period.
- Participants able to safely participate in the prescribed physical-performance testing and training programme.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- Irregular menstrual cycles or diagnosed menstrual disorders.
- Use of hormonal contraceptives or hormone therapy within the past 6 months.
- Current musculoskeletal injury or any medical condition affecting physical performance.
- Use of medications known to influence menstrual function, hormonal responses, or physical performance.
- Use of performance-enhancing drugs or medications known to influence hormonal or biochemical responses.
- History of endocrine, cardiovascular, or metabolic disorders.
- Failure to complete all scheduled testing sessions.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Female Futsal Players
Female futsal players will undergo repeated standardized performance testing during different phases of the menstrual cycle.
Assessments include agility, sprint speed, repeated sprint ability, explosive power, balance, and aerobic fitness.
All participants receive the same testing protocol, and no therapeutic intervention is administered.
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Female futsal players will undergo standardized physical performance testing during different phases of the menstrual cycle.
Assessments include agility, sprint speed, repeated sprint ability, explosive power, balance, and aerobic fitness.
The study involves repeated performance assessments only, and no drug, device, surgical procedure, or therapeutic intervention will be administered.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Mean Change from Baseline in Maximum Oxygen Uptake (VO₂max)
Ramy czasowe: Baseline and Week 10
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Maximum oxygen uptake (VO₂max) measured during a graded incremental treadmill exercise test with respiratory gas analysis.
Unit of Measure: mL·kg-¹·min-¹.
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Baseline and Week 10
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Mean Change from Baseline in Velocity at VO₂max (vVO₂max)
Ramy czasowe: Baseline and Week 10
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Velocity at VO₂max (vVO₂max) measured during a graded incremental treadmill exercise test.
Unit of Measure: km/h.
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Baseline and Week 10
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Mean Change from Baseline in Lactate Threshold Velocity
Ramy czasowe: Baseline and Week 10
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Lactate threshold velocity determined during incremental exercise testing.
Lactate threshold velocity is defined as the running velocity corresponding to the lactate threshold.
Unit of measure: km/h.
Higher values indicate improved aerobic endurance.
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Baseline and Week 10
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Mean Change from Baseline in Resting Blood Lactate Concentration
Ramy czasowe: Baseline and Week 10
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Resting blood lactate concentration measured from venous blood samples collected under standardized resting conditions before exercise.
Unit of Measure: mmol/L.
Lower concentrations indicate improved metabolic efficiency.
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Baseline and Week 10
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Mean Change from Baseline in Lactate Clearance Rate
Ramy czasowe: Baseline and Week 10
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Lactate clearance rate calculated as the rate of decline in blood lactate concentration from serial post-exercise measurements obtained during standardized recovery.
The calculated clearance rate is reported as one value in mmol/L/min.
Higher clearance rates indicate improved metabolic recovery.
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Baseline and Week 10
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Serum Creatine Kinase (CK) Concentration at Predefined Recovery Time Points
Ramy czasowe: Baseline; immediately post-exercise; 24 hours; 48 hours; and 72 hours
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Serum creatine kinase concentration measured at baseline and predefined post-exercise recovery time points.
Repeated CK concentrations are evaluated across the predefined sampling time points.
Unit of Measure: U/L.
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Baseline; immediately post-exercise; 24 hours; 48 hours; and 72 hours
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Interleukin-6 (IL-6)
Ramy czasowe: Baseline; immediately post-exercise; and recovery period
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Serum interleukin-6 concentration measured as an indicator of exercise-induced inflammatory response.
Unit of Measure: pg/mL.
Lower resting concentrations and appropriate acute exercise responses indicate improved inflammatory regulation.
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Baseline; immediately post-exercise; and recovery period
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Serum Cortisol
Ramy czasowe: Baseline; menstrual phase-specific assessments; and Week 10
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Serum cortisol concentration measured to evaluate physiological stress responses associated with high-intensity interval training.
Unit of Measure: µg/dL.
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Baseline; menstrual phase-specific assessments; and Week 10
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Serum Estradiol
Ramy czasowe: Phase-specific assessments during the intervention
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Serum estradiol concentration measured to characterize hormonal status during different phases of the menstrual cycle.
Unit of Measure: pg/mL.
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Phase-specific assessments during the intervention
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Serum Progesterone
Ramy czasowe: Phase-specific assessments during the intervention
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Serum progesterone concentration measured to confirm menstrual cycle phase and evaluate hormonal responses during the intervention.
Unit of Measure: ng/mL.
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Phase-specific assessments during the intervention
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Creatine Kinase (CK) Recovery Half-Life
Ramy czasowe: Immediately post-exercise through 72 hours
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Time required for serum creatine kinase concentration to decrease by 50% during the post-exercise recovery period.
Unit of Measure: hours.
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Immediately post-exercise through 72 hours
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Area Under the Concentration-Time Curve of Serum Creatine Kinase (CK)
Ramy czasowe: Immediately post-exercise through 72 hours
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Area under the serum creatine kinase concentration-time curve calculated from serum CK concentrations measured during the post-exercise recovery period.
Unit of Measure: U/L·h.
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Immediately post-exercise through 72 hours
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- Buchheit M, Laursen PB. High-intensity interval training, solutions to the programming puzzle: Part I: cardiopulmonary emphasis. Sports Med. 2013 May;43(5):313-38. doi: 10.1007/s40279-013-0029-x.
- Laursen PB, Jenkins DG. The scientific basis for high-intensity interval training: optimising training programmes and maximising performance in highly trained endurance athletes. Sports Med. 2002;32(1):53-73. doi: 10.2165/00007256-200232010-00003.
- Janse de Jonge XA. Effects of the menstrual cycle on exercise performance. Sports Med. 2003;33(11):833-51. doi: 10.2165/00007256-200333110-00004.
- Janse DE Jonge X, Thompson B, Han A. Methodological Recommendations for Menstrual Cycle Research in Sports and Exercise. Med Sci Sports Exerc. 2019 Dec;51(12):2610-2617. doi: 10.1249/MSS.0000000000002073.
- Constantini NW, Dubnov G, Lebrun CM. The menstrual cycle and sport performance. Clin Sports Med. 2005 Apr;24(2):e51-82, xiii-xiv. doi: 10.1016/j.csm.2005.01.003.
- Souglis A, Bourdas DI, Gioldasis A, Ispirlidis I, Philippou A, Zacharakis E, Apostolidis A, Efthymiou G, Travlos AK. Time Course of Performance Indexes, Oxidative Stress, Inflammation, and Muscle Damage Markers after a Female Futsal Match. Sports (Basel). 2023 Jun 29;11(7):127. doi: 10.3390/sports11070127.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
2 lutego 2026
Zakończenie podstawowe (Rzeczywisty)
1 lipca 2026
Ukończenie studiów (Rzeczywisty)
1 lipca 2026
Daty rejestracji na studia
Pierwszy przesłany
31 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
14 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
19 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
20 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
19 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- SORANU-HIIT-2026-001
- Ethics Approval Number (Inny identyfikator: Soran University Institutional Review Board)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Opis planu IPD
A decision regarding sharing de-identified individual participant data collected in this study has not yet been finalized.
If data sharing is approved, only de-identified data may be considered for sharing after study completion, subject to institutional policies, ethical requirements, participant confidentiality, and applicable data-protection requirements.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .