NCT07773519

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

July 31, 2026

Last Update Submit

August 19, 2026

Conditions

Keywords

Female Futsal PlayersMenstrual CycleHigh-Intensity Interval TrainingExercise PhysiologyWomen's HealthPhysical Performance

Outcome Measures

Primary Outcomes (5)

  • Mean Change from Baseline in Maximum Oxygen Uptake (VO₂max)

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

    Baseline and Week 10

  • Mean Change from Baseline in Velocity at VO₂max (vVO₂max)

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

    Baseline and Week 10

  • Mean Change from Baseline in Lactate Threshold Velocity

    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.

    Baseline and Week 10

  • Mean Change from Baseline in Resting Blood Lactate Concentration

    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.

    Baseline and Week 10

  • Mean Change from Baseline in Lactate Clearance Rate

    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.

    Baseline and Week 10

Secondary Outcomes (5)

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

    Baseline; immediately post-exercise; 24 hours; 48 hours; and 72 hours

  • Interleukin-6 (IL-6)

    Baseline; immediately post-exercise; and recovery period

  • Serum Cortisol

    Baseline; menstrual phase-specific assessments; and Week 10

  • Serum Estradiol

    Phase-specific assessments during the intervention

  • Serum Progesterone

    Phase-specific assessments during the intervention

Other Outcomes (2)

  • Creatine Kinase (CK) Recovery Half-Life

    Immediately post-exercise through 72 hours

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

    Immediately post-exercise through 72 hours

Study Arms (1)

Female Futsal Players

EXPERIMENTAL

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.

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

Interventions

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.

Also known as: Futsal Performance Testing
Female Futsal Players

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soran Univeristy

Soran, Erbil Governorate, 44008, Iraq

Location

Related Publications (6)

  • 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.

    PMID: 31246715BACKGROUND
  • 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.

    PMID: 12959622BACKGROUND
  • 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.

    PMID: 15892917BACKGROUND
  • 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.

    PMID: 11772161BACKGROUND
  • 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.

    PMID: 23539308BACKGROUND
  • 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.

    PMID: 37505614BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Different phases of mensuration was studies
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher at soran university

Study Record Dates

First Submitted

July 31, 2026

First Posted

August 19, 2026

Study Start

February 2, 2026

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

August 20, 2026

Record last verified: 2026-08

Locations