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- Ensayo clínico NCT07773519
Effects of a 10-Week High-Intensity Interval Training Programme on Biochemical and Hormonal Responses in Elite Female Futsal Players
19 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
32
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Erbil Governorate
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Soran, Erbil Governorate, Irak, 44008
- Soran Univeristy
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean Change from Baseline in Maximum Oxygen Uptake (VO₂max)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Serum Creatine Kinase (CK) Concentration at Predefined Recovery Time Points
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Creatine Kinase (CK) Recovery Half-Life
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
2 de febrero de 2026
Finalización primaria (Actual)
1 de julio de 2026
Finalización del estudio (Actual)
1 de julio de 2026
Fechas de registro del estudio
Enviado por primera vez
31 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de agosto de 2026
Publicado por primera vez (Actual)
19 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
19 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- SORANU-HIIT-2026-001
- Ethics Approval Number (Otro identificador: Soran University Institutional Review Board)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .