- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07575802
Lower Limb Strength and Power as Predictors of Brain Blood Flow During Exercise (LLSPP)
May 4, 2026 updated by: Linjun Liu, Lincoln University College
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
256
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Moscow, Russia, 117519
- Moscow State University of Sport and Tourism
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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%.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Standardized Physical Performance and Hemodynamic Observation Group
Observational Study Arm
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Cortical hemodynamics are measured using the NIRSport2 fNIRS system over the bilateral dorsolateral prefrontal cortex (DLPFC).
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Measured during the 6-minute constant-load cycling task (60%VO_2max), which occurs approximately 120 minutes after the start of the experimental session.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Demographic and Morphological Baseline Profile
Time Frame: Baseline (Minutes 0-20 of the session).
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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.
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Baseline (Minutes 0-20 of the session).
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Isokinetic Neuromuscular Strength Battery
Time Frame: Post-baseline assessment (Minutes 30-60 of the session).
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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.
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Post-baseline assessment (Minutes 30-60 of the session).
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Explosive Power and Functional Performance Metric
Time Frame: Following isokinetic testing (Minutes 70-90 of the session).
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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.
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Following isokinetic testing (Minutes 70-90 of the session).
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Peak Cardiorespiratory Capacity (VO_2max)
Time Frame: Final physical assessment before the hemodynamic task (Minutes 100-120 of the session).
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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.
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Final physical assessment before the hemodynamic task (Minutes 100-120 of the session).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2025
Primary Completion (Actual)
March 15, 2025
Study Completion (Actual)
March 15, 2025
Study Registration Dates
First Submitted
May 4, 2026
First Submitted That Met QC Criteria
May 4, 2026
First Posted (Actual)
May 8, 2026
Study Record Updates
Last Update Posted (Actual)
May 8, 2026
Last Update Submitted That Met QC Criteria
May 4, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- WSUST-IRB-070225
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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