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- Sperimentazione clinica NCT07773519
Effects of a 10-Week High-Intensity Interval Training Programme on Biochemical and Hormonal Responses in Elite Female Futsal Players
19 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
32
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Erbil Governorate
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Soran, Erbil Governorate, Iraq, 44008
- Soran Univeristy
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Mean Change from Baseline in Maximum Oxygen Uptake (VO₂max)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Serum Creatine Kinase (CK) Concentration at Predefined Recovery Time Points
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Creatine Kinase (CK) Recovery Half-Life
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
2 febbraio 2026
Completamento primario (Effettivo)
1 luglio 2026
Completamento dello studio (Effettivo)
1 luglio 2026
Date di iscrizione allo studio
Primo inviato
31 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
14 agosto 2026
Primo Inserito (Effettivo)
19 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
20 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
19 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- SORANU-HIIT-2026-001
- Ethics Approval Number (Altro identificatore: Soran University Institutional Review Board)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .