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Completed

NCT Number: NCT07773519

Effects of a 10-Week High-Intensity Interval Training Programme on Biochemical and Hormonal Responses in Elite Female Futsal Players

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.

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Key information

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Soran Univeristy

Soran, Erbil Governorate, 44008, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Repeated Futsal Performance Testing Across Menstrual Cycle Phases Intervention Description Participants will undergo standardized futsal-specific performance assessments during different phases of the

Behavioral

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.

Other names: Futsal Performance Testing

Primary outcomes

  1. Mean Change from Baseline in Maximum Oxygen Uptake (VO₂max)

    Time frame: Baseline and Week 10

    Maximum oxygen uptake (VO₂max) measured during a graded incremental treadmill exercise test with respiratory gas analysis. Unit of Measure: mL·kg-¹·min-¹.

  2. Mean Change from Baseline in Velocity at VO₂max (vVO₂max)

    Time frame: Baseline and Week 10

    Velocity at VO₂max (vVO₂max) measured during a graded incremental treadmill exercise test. Unit of Measure: km/h.

  3. Mean Change from Baseline in Lactate Threshold Velocity

    Time frame: Baseline and Week 10

    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.

  4. Mean Change from Baseline in Resting Blood Lactate Concentration

    Time frame: Baseline and Week 10

    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.

  5. Mean Change from Baseline in Lactate Clearance Rate

    Time frame: Baseline and Week 10

    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.

Secondary outcomes

  1. Serum Creatine Kinase (CK) Concentration at Predefined Recovery Time Points

    Time frame: Baseline; immediately post-exercise; 24 hours; 48 hours; and 72 hours

    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.

  2. Interleukin-6 (IL-6)

    Time frame: Baseline; immediately post-exercise; and recovery period

    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.

  3. Serum Cortisol

    Time frame: Baseline; menstrual phase-specific assessments; and Week 10

    Serum cortisol concentration measured to evaluate physiological stress responses associated with high-intensity interval training. Unit of Measure: µg/dL.

  4. Serum Estradiol

    Time frame: Phase-specific assessments during the intervention

    Serum estradiol concentration measured to characterize hormonal status during different phases of the menstrual cycle. Unit of Measure: pg/mL.

  5. Serum Progesterone

    Time frame: Phase-specific assessments during the intervention

    Serum progesterone concentration measured to confirm menstrual cycle phase and evaluate hormonal responses during the intervention. Unit of Measure: ng/mL.

Other outcomes

  1. Creatine Kinase (CK) Recovery Half-Life

    Time frame: Immediately post-exercise through 72 hours

    Time required for serum creatine kinase concentration to decrease by 50% during the post-exercise recovery period. Unit of Measure: hours.

  2. Area Under the Concentration-Time Curve of Serum Creatine Kinase (CK)

    Time frame: Immediately post-exercise through 72 hours

    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.

Sponsors and collaborators

Lead sponsor

Soran University

Other

Registry information

Official study title

Temporal Dynamics of Biochemical and Hormonal Responses to Interval Training in Elite Female Futsal Players: A 10-Week Longitudinal Analysis Across Menstrual Cycle Phases

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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