Prefrontal HemodynamicsLLSPPNCT07575802
Lower Limb Strength and Power as Predictors of Brain Blood Flow During Exercise
A study testing Standardized Lower-Limb Physical Performance Assessment and Aerobic Exercise Task in people with Prefrontal Hemodynamics and Muscle Strength, run by Lincoln University College at 1 site in Russia.
Trial summary
This study aims to investigate the predictive value of lower limb muscle strength and explosive power on exercise-induced prefrontal hemodynamic responses. Using an interpretable machine learning framework (GCAT-Net), the research analyzes how various physical performance indicators-such as isokinetic muscle strength… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Prefrontal Hemodynamics, Muscle Strength, Physical Performance
- What is being tested?
- Standardized Lower-Limb Physical Performance Assessment and Aerobic Exercise Task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2025to 15 Mar 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged between 18.00 and 60.00 years.
- Must be able to perform standardized lower-limb physical assessments, including isokinetic strength testing and explosive power tests (e.g., CMJ, SJ, and 30m sprints).
- Capability to complete a 6-minute aerobic cycling task at a moderate intensity (60% VO_2max).
- Physically cleared for exercise as determined by a Physical Activity Readiness Questionnaire (PAR-Q).
- Willingness to undergo functional near-infrared spectroscopy (fNIRS) monitoring with a Scalp Coupling Index (SCI) ≥ 0.7.
Who cannot join
- History of musculoskeletal injuries to the lower limbs within the past 6 months that would impede maximum voluntary contraction (MVC) or high-intensity efforts.
- Known cardiovascular, respiratory, or neurological conditions that contraindicate maximal exercise testing (VO_2max ramp protocol).
- Body Mass Index (BMI) or health status that prevents the safe completion of high-impact explosive power tests like the 30cm drop jump (RSI assessment).
- Presence of excessive motion artifacts or poor fNIRS signal quality, specifically a Signal-to-Noise Ratio (SNR) < 5 dB or motion artifact frame ratio ≥$ 10%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lower Limb Muscle Strength and Power Predict Exercise-Induced Prefrontal Hemodynamic Response: An Interpretable Machine Learning Study Using fNIRS Data
This study aims to investigate the predictive value of lower limb muscle strength and explosive power on exercise-induced prefrontal hemodynamic responses. Using an interpretable machine learning framework (GCAT-Net), the research analyzes how various physical performance indicators-such as isokinetic muscle strength, 1RM leg press, and vertical jump metrics-can predict oxygenated hemoglobin (ΔHbO) changes in the bilateral dorsolateral prefrontal cortex (DLPFC) during moderate-intensity cycling.
- Being tested
- Standardized Lower-Limb Physical Performance Assessment and Aerobic Exercise Task
- Keywords
- functional near-infrared spectroscopy, prefrontal cortex, lower-limb power, muscle strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Lower-Limb Physical Performance Assessment and Aerobic Exercise TaskOther
Participants undergo a comprehensive physiological and biomechanical assessment protocol divided into three phases. First, demographic and morphological data (Age, Sex, BMI, and Body Fat %) are collected, followed by a maximal oxygen consumption (VO_2max) test using a Bruce-modified ramp protocol on a cycle ergometer. Second, participants complete a standardized lower-limb neuromuscular battery, including isokinetic strength testing at 60°/s (peak torque for knee, hip, and ankle) via a Biodex System 4 Pro, a 1RM leg press, and explosive power assessments comprising Countermovement Jumps (CMJ), Squat Jumps (SJ), and 30m sprints. Finally, cortical hemodynamic activity is monitored using a 16-channel fNIRS system (NIRSport2) over the bilateral dorsolateral prefrontal cortex (DLPFC) during a 6-minute constant-load cycling task at 60% VO_2max.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Physical Performance and Hemodynamic Observation Group | Other | Observational Study Arm Receives: Other: Standardized Lower-Limb Physical Performance Assessment and Aerobic Exercise Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve of Oxygenated Hemoglobin (Δ HbO AUC) during Aerobic Exercise
Cortical hemodynamics are measured using the NIRSport2 fNIRS system over the bilateral dorsolateral prefrontal cortex (DLPFC).
Measured: Measured during the 6-minute constant-load cycling task (60%VO_2max), which occurs approximately 120 minutes after the start of the experimental session.
Secondary outcomes (4)
Demographic and Morphological Baseline Profile
Collection of foundational participant data including Age, Height (InBody H20N), Weight, BMI, and Body Fat % (InBody 770 via multi-frequency bioelectrical impedance). Resting Heart Rate (RHR) is recorded after 5 minutes of quiet rest.
Measured: Baseline (Minutes 0-20 of the session).
Isokinetic Neuromuscular Strength Battery
Evaluation of lower-limb strength using a Biodex System 4 Pro at an angular velocity of 60°/s. Metrics include peak torque for knee extension/flexion, hip extension, and ankle plantarflexion, as well as the 1RM leg press and Hamstring/Quadriceps (H:Q) ratio.
Measured: Post-baseline assessment (Minutes 30-60 of the session).
Explosive Power and Functional Performance Metric
Assessment of neuromuscular power through Countermovement Jump (CMJ), Squat Jump (SJ), Reactive Strength Index (RSI via 30cm drop jump), 30m sprint time, and standing long jump. Functional strength is measured using the Five Times Sit-to-Stand (FiveTSTS) test.
Measured: Following isokinetic testing (Minutes 70-90 of the session).
Peak Cardiorespiratory Capacity (VO_2max)
Maximal oxygen consumption determined through a Bruce-modified ramp protocol (25 W starting load, increasing 25 W/min) on a cycle ergometer until volitional exhaustion.
Measured: Final physical assessment before the hemodynamic task (Minutes 100-120 of the session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Mar 2025
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prefrontal HemodynamicsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lincoln University College
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan University of Technology
- Responsible party
- Principal investigator, Linjun Liu, Lincoln University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575802
- Sponsor's protocol ID
- WSUST-IRB-070225
- Acronym
- LLSPP
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Limb Muscle Strength and Power Predict Exercise-Induced Prefrontal Hemodynamic Response: An Interpretable Machine Learning Study Using fNIRS Data
- ClinicalTrials.gov ID
- NCT07575802
- Acronym / sponsor ID
- LLSPP / WSUST-IRB-070225
- Keywords
- functional near-infrared spectroscopy, prefrontal cortex, lower-limb power, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Lincoln University CollegeUniversity, hospital or other
- Collaborators
- Wuhan University of Technology
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 8 May 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 predictive value of lower limb muscle strength and explosive power on exercise-induced prefrontal hemodynamic responses. Using an interpretable machine learning framework (GCAT-Net), the research analyzes how various physical performance indicators-such as isokinetic muscle strength, 1RM leg press, and vertical jump metrics-can predict oxygenated hemoglobin (ΔHbO) changes in the bilateral dorsolateral prefrontal cortex (DLPFC) during moderate-intensity cycling.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standardized Physical Performance and Hemodynamic Observation Group | Other | Other: Standardized Lower-Limb Physical Performance Assessment and Aerobic Exercise TaskObservational Study Arm |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adults aged between 18.00 and 60.00 years.
- Must be able to perform standardized lower-limb physical assessments, including isokinetic strength testing and explosive power tests (e.g., CMJ, SJ, and 30m sprints).
- Capability to complete a 6-minute aerobic cycling task at a moderate intensity (60% VO_2max).
- Physically cleared for exercise as determined by a Physical Activity Readiness Questionnaire (PAR-Q).
- Willingness to undergo functional near-infrared spectroscopy (fNIRS) monitoring with a Scalp Coupling Index (SCI) ≥ 0.7.
Key exclusion criteria (4 listed)
- History of musculoskeletal injuries to the lower limbs within the past 6 months that would impede maximum voluntary contraction (MVC) or high-intensity efforts.
- Known cardiovascular, respiratory, or neurological conditions that contraindicate maximal exercise testing (VO_2max ramp protocol).
- Body Mass Index (BMI) or health status that prevents the safe completion of high-impact explosive power tests like the 30cm drop jump (RSI assessment).
- Presence of excessive motion artifacts or poor fNIRS signal quality, specifically a Signal-to-Noise Ratio (SNR) < 5 dB or motion artifact frame ratio ≥$ 10%.
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 |
|---|---|---|
| Standardized Lower-Limb Physical Performance Assessment and Aerobic Exercise TaskParticipants undergo a comprehensive physiological and biomechanical assessment protocol divided into three phases. First, demographic and morphological data (Age, Sex, BMI, and Body Fat %) are collected, followed by a maximal oxygen consumption (VO_2max) test using a Bruce-modified ramp protocol on a cycle ergometer. Second, participants complete a standardized lower-limb neuromuscular battery, including isokinetic strength testing at 60°/s (peak torque for knee, hip, and ankle) via a Biodex System 4 Pro, a 1RM leg press, and explosive power assessments comprising Countermovement Jumps (CMJ), Squat Jumps (SJ), and 30m sprints. Finally, cortical hemodynamic activity is monitored using a 16-channel fNIRS system (NIRSport2) over the bilateral dorsolateral prefrontal cortex (DLPFC) during a 6-minute constant-load cycling task at 60% VO_2max. | Other | Standardized Physical Performance and Hemodynamic Observation Group |
Primary outcome
Area Under the Curve of Oxygenated Hemoglobin (Δ HbO AUC) during Aerobic Exercise
Time frame: Measured during the 6-minute constant-load cycling task (60%VO_2max), which occurs approximately 120 minutes after the start of the experimental session.
Cortical hemodynamics are measured using the NIRSport2 fNIRS system over the bilateral dorsolateral prefrontal cortex (DLPFC).
4 secondary outcomes
Demographic and Morphological Baseline Profile
Time frame: Baseline (Minutes 0-20 of the session).
Isokinetic Neuromuscular Strength Battery
Time frame: Post-baseline assessment (Minutes 30-60 of the session).
Explosive Power and Functional Performance Metric
Time frame: Following isokinetic testing (Minutes 70-90 of the session).
Peak Cardiorespiratory Capacity (VO_2max)
Time frame: Final physical assessment before the hemodynamic task (Minutes 100-120 of the session).
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 8 May 2026.
- Individual participant dataSharing planned: No
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 Standardized Lower-Limb Physical Performance Assessment and Aerobic Exercise Task in people with Prefrontal Hemodynamics and Muscle Strength, run by Lincoln University College at 1 site in Russia.
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 5 inclusion and 4 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 8 May 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 Russia. 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?
Area Under the Curve of Oxygenated Hemoglobin (Δ HbO AUC) during Aerobic Exercise (time frame: Measured during the 6-minute constant-load cycling task (60%VO_2max), which occurs approximately 120 minutes after the start of the experimental session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.