NCT07575802

Brief 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, 1RM leg press, and vertical jump metrics-can predict oxygenated hemoglobin (ΔHbO) changes in the bilateral dorsolateral prefrontal cortex (DLPFC) during moderate-intensity cycling.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

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

March 1, 2025

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

14 days

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

functional near-infrared spectroscopyprefrontal cortexlower-limb powermuscle strength

Outcome Measures

Primary Outcomes (1)

  • 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 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

    Baseline (Minutes 0-20 of the session).

  • Isokinetic Neuromuscular Strength Battery

    Post-baseline assessment (Minutes 30-60 of the session).

  • Explosive Power and Functional Performance Metric

    Following isokinetic testing (Minutes 70-90 of the session).

  • Peak Cardiorespiratory Capacity (VO_2max)

    Final physical assessment before the hemodynamic task (Minutes 100-120 of the session).

Study Arms (1)

Standardized Physical Performance and Hemodynamic Observation Group

OTHER

Observational Study Arm

Other: Standardized Lower-Limb Physical Performance Assessment and Aerobic Exercise Task

Interventions

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.

Standardized Physical Performance and Hemodynamic Observation Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moscow State University of Sport and Tourism

Moscow, 117519, Russia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Researcher

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start

March 1, 2025

Primary Completion

March 15, 2025

Study Completion

March 15, 2025

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations