Exercise PhysiologyNCT07773519
Effects of a 10-Week High-Intensity Interval Training Programme on Biochemical and Hormonal Responses in Elite Female Futsal Players
A study testing Repeated Futsal Performance Testing Across Menstrual Cycle Phases Intervention Description Participants will undergo standardized futsal-specific performance assessments during different phases of the in people with Exercise Physiology and High-Intensity Interval Training, run by Soran University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Physiology, High-Intensity Interval Training, Female Athletes
- What is being tested?
- Repeated Futsal Performance Testing Across Menstrual Cycle Phases Intervention Description Participants will undergo standardized futsal-specific performance assessments during different phases of the
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIraq
- Study dates
- 2 Feb 2026to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Repeated Futsal Performance Testing Across Menstrual Cycle Phases Intervention Description Participants will undergo standardized futsal-specific performance assessments during different phases of the
- Keywords
- Female Futsal Players, Menstrual Cycle, High-Intensity Interval Training, Exercise Physiology, Women's Health, Physical Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated Futsal Performance Testing Across Menstrual Cycle Phases Intervention Description Participants will undergo standardized futsal-specific performance assessments during different phases of theBehavioural
Also called Futsal Performance Testing
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Repeated Futsal Performance Testing Across Menstrual Cycle Phases Intervention Description Participants will undergo standardized futsal-specific performance assessments during different phases of the |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 10
Secondary outcomes (5)
Serum Creatine Kinase (CK) Concentration at Predefined Recovery Time Points
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.
Measured: Baseline; immediately post-exercise; 24 hours; 48 hours; and 72 hours
Interleukin-6 (IL-6)
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.
Measured: Baseline; immediately post-exercise; and recovery period
Serum Cortisol
Serum cortisol concentration measured to evaluate physiological stress responses associated with high-intensity interval training. Unit of Measure: µg/dL.
Measured: Baseline; menstrual phase-specific assessments; and Week 10
Serum Estradiol
Serum estradiol concentration measured to characterize hormonal status during different phases of the menstrual cycle. Unit of Measure: pg/mL.
Measured: Phase-specific assessments during the intervention
Serum Progesterone
Serum progesterone concentration measured to confirm menstrual cycle phase and evaluate hormonal responses during the intervention. Unit of Measure: ng/mL.
Measured: Phase-specific assessments during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start2 Feb 2026
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Exercise PhysiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Different phases of mensuration was studies
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimal Hamza Hamad, Soran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773519
- Sponsor's protocol ID
- SORANU-HIIT-2026-001
- Other IDs
- Ethics Approval Number
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 31246715Janse de Jonge XA. Effects of the menstrual cycle on exercise performance. Sports Med. 2003;33(11):833-51. doi: 10.2165/00007256-200333110-00004.
PubMed 12959622Constantini 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.
PubMed 15892917Laursen 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.
PubMed 11772161Buchheit 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.
PubMed 23539308Souglis 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.
PubMed 37505614
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07773519
- Acronym / sponsor ID
- SORANU-HIIT-2026-001
- Keywords
- Female Futsal Players, Menstrual Cycle, High-Intensity Interval Training, Exercise Physiology, Women's Health, Physical Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Soran UniversityUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Different phases of mensuration was studies
| Arm | Type | Receives |
|---|---|---|
| Female Futsal Players | Experimental | Behavioral: Repeated Futsal Performance Testing Across Menstrual Cycle Phases Intervention Description Participants will undergo standardized futsal-specific performance assessments during different phases of theFemale 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repeated Futsal Performance Testing Across Menstrual Cycle Phases Intervention Description Participants will undergo standardized futsal-specific performance assessments during different phases of theAlso: Futsal Performance TestingFemale 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. | Behavioural | Female Futsal Players |
Primary outcome
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.
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.
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.
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.
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.
5 secondary outcomes
Serum Creatine Kinase (CK) Concentration at Predefined Recovery Time Points
Time frame: Baseline; immediately post-exercise; 24 hours; 48 hours; and 72 hours
Interleukin-6 (IL-6)
Time frame: Baseline; immediately post-exercise; and recovery period
Serum Cortisol
Time frame: Baseline; menstrual phase-specific assessments; and Week 10
Serum Estradiol
Time frame: Phase-specific assessments during the intervention
Serum Progesterone
Time frame: Phase-specific assessments during the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 31246715Janse 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.
- Background: PubMed 12959622Janse de Jonge XA. Effects of the menstrual cycle on exercise performance. Sports Med. 2003;33(11):833-51. doi: 10.2165/00007256-200333110-00004.
- Background: PubMed 15892917Constantini 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.
- Background: PubMed 11772161Laursen 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.
- Background: PubMed 23539308Buchheit 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.
- Background: PubMed 37505614Souglis 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated Futsal Performance Testing Across Menstrual Cycle Phases Intervention Description Participants will undergo standardized futsal-specific performance assessments during different phases of the in people with Exercise Physiology and High-Intensity Interval Training, run by Soran University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline in Maximum Oxygen Uptake (VO₂max) (time frame: Baseline and Week 10). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07773519, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.