NCT07808814

Brief Summary

This randomized, sham-controlled, two-period crossover study evaluated the effects of portable 808-nm low-level laser therapy (LLLT) on acute recovery and running biomechanics following a quadriceps-dominant fatiguing task in recreational runners. Twenty male recreational runners completed both active LLLT and sham conditions, separated by a 2-week washout period. After the fatiguing task, participants received 10 minutes of bilateral quadriceps LLLT or sham treatment, followed by treadmill running at the same fixed self-selected speed. Quadriceps soreness, heart rate, running spatiotemporal parameters, and kinematic responses were assessed using a verbal numerical rating scale, heart-rate monitoring, two-dimensional video analysis, and inertial measurement units.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 2, 2026

Last Update Submit

September 2, 2026

Conditions

Keywords

Running BiomechanicsInertial Measurement UnitsLow-Level Laser TherapyPhotobiomodulation TherapyRecreational Runners

Outcome Measures

Primary Outcomes (10)

  • Quadriceps Soreness

    Quadriceps soreness was assessed using a 0-10 verbal numerical rating scale (VNRS), where 0 indicated no soreness and 10 indicated the worst imaginable soreness. Decimal responses were permitted.

    Immediately after the 10-minute intervention and before the post-intervention running trial.

  • Distal-Tibial Acceleration at Initial Contact

    Resultant distal-tibial acceleration was measured using bilateral inertial measurement units and expressed in meters per second squared (m/s²). Values from 10 consecutive steps were averaged for each limb, and the left- and right-limb means were subsequently averaged.

    At initial contact during the post-intervention treadmill running trial; events were identified within the 60-120-second analysis interval.

  • Distal-Tibial Angular Velocity at Initial Contact

    Resultant distal-tibial angular velocity was measured using bilateral inertial measurement units and expressed in degrees per second (°/s). Values from 10 consecutive steps were averaged for each limb, and the left- and right-limb means were subsequently averaged.

    At initial contact during the post-intervention treadmill running trial; events were identified within the 60-120-second analysis interval.

  • Distal-Tibial Angular Velocity at Toe-Off

    Resultant distal-tibial angular velocity was measured using bilateral inertial measurement units and expressed in degrees per second (°/s). Values from 10 consecutive steps were averaged for each limb, and the left- and right-limb means were subsequently averaged.

    At toe-off during the post-intervention treadmill running trial; events were identified within the 60-120-second analysis interval.

  • Distal-Tibial Acceleration at Toe-Off

    Resultant distal-tibial acceleration was measured using bilateral inertial measurement units and expressed in meters per second squared (m/s²). Values from 10 consecutive steps were averaged for each limb, and the left- and right-limb means were subsequently averaged.

    At toe-off during the post-intervention treadmill running trial; events were identified within the 60-120-second analysis interval.

  • Step Width During Running

    Step width was measured from posterior-view two-dimensional video analysis and expressed in centimeters. Ten consecutive steps were analyzed and averaged for each participant and condition.

    During the 3-minute post-intervention treadmill running trial; 10 consecutive steps were analyzed from 60 to 120 seconds after the start of running.

  • Sacral Acceleration at Initial Contact

    Resultant sacral acceleration was measured using an inertial measurement unit positioned over the S2 region and expressed in meters per second squared (m/s²). Values from 10 consecutive steps were averaged for each participant and condition.

    At initial contact during the post-intervention treadmill running trial; events were identified within the 60-120-second analysis interval.

  • Sacral Acceleration at Toe-Off

    Resultant sacral acceleration was measured using an inertial measurement unit positioned over the S2 region and expressed in meters per second squared (m/s²). Values from 10 consecutive steps were averaged for each participant and condition.

    At toe-off during the post-intervention treadmill running trial; events were identified within the 60-120-second analysis interval.

  • Sacral Angular Velocity at Initial Contact

    Resultant sacral angular velocity was measured using an inertial measurement unit positioned over the S2 region and expressed in degrees per second (°/s). Values from 10 consecutive steps were averaged for each participant and condition.

    At initial contact during the post-intervention treadmill running trial; events were identified within the 60-120-second analysis interval.

  • Sacral Angular Velocity at Toe-Off

    Resultant sacral angular velocity was measured using an inertial measurement unit positioned over the S2 region and expressed in degrees per second (°/s). Values from 10 consecutive steps were averaged for each participant and condition.

    At toe-off during the post-intervention treadmill running trial; events were identified within the 60-120-second analysis interval.

Secondary Outcomes (5)

  • Heart Rate at the End of the Intervention

    During the final 10 seconds of the 10-minute intervention.

  • Sagittal Trunk Inclination Angle at Initial Contact

    At initial contact during the post-intervention treadmill running trial; 10 consecutive steps were analyzed from 60 to 120 seconds after the start of running.

  • Sagittal Trunk Inclination Angle at Toe-Off

    At toe-off during the post-intervention treadmill running trial; 10 consecutive steps were analyzed from 60 to 120 seconds after the start of running.

  • Knee-Flexion Angle at Initial Contact

    At initial contact during the post-intervention treadmill running trial; 10 consecutive steps were analyzed from 60 to 120 seconds after the start of running.

  • Knee-Flexion Angle at Toe-Off

    At toe-off during the post-intervention treadmill running trial; 10 consecutive steps were analyzed from 60 to 120 seconds after the start of running.

Study Arms (2)

LLLT-Sham Sequence

EXPERIMENTAL

Participants received LLLT during the first experimental period and sham during the second experimental period, with a 2-week washout period between visits.

Device: LLLTDevice: Sham

Sham-LLLT Sequence

EXPERIMENTAL

Participants received sham during the first experimental period and LLLT during the second experimental period, with a 2-week washout period between visits.

Device: LLLTDevice: Sham

Interventions

LLLTDEVICE

Portable 808-nm low-level laser therapy applied bilaterally to the rectus femoris, vastus lateralis, and vastus medialis for 10 minutes.

LLLT-Sham SequenceSham-LLLT Sequence
ShamDEVICE

Sham device applied to the same bilateral quadriceps sites for 10 minutes, matching the LLLT condition in device appearance, placement, duration, and fixation.

LLLT-Sham SequenceSham-LLLT Sequence

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male recreational runners aged 18-40 years.
  • Recreational running status determined using the World Masters Athletics (WMA) age-graded performance score, with an age-graded score below 60%.
  • Previous experience with treadmill running.
  • Rearfoot-strike running pattern.
  • No running-related lower-limb injury during the preceding 6 months

You may not qualify if:

  • WMA age-graded performance score of 60% or higher.
  • Non-rearfoot-strike running pattern.
  • Leg-length discrepancy greater than 3 cm.
  • Use of an orthosis, brace, or other lower-limb medical device that could influence running gait.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chia Nan University of Pharmacy & Science

Tainan, 717301, Taiwan

Location

Related Publications (5)

  • do Nascimento AP, de Oliveira GA, Bressanin JPB, Aguirra P, Ribeiro AS, Caldeira LFS, Casonatto J, Ferraresi C, Aguiar AF. Acute dose-response effect of photobiomodulation therapy on 5-km running performance in trained runners: a randomized, double-blind, placebo-controlled, crossover study. Lasers Med Sci. 2024 May 31;39(1):145. doi: 10.1007/s10103-024-04099-8.

  • De Marchi T, Leal Junior EC, Bortoli C, Tomazoni SS, Lopes-Martins RA, Salvador M. Low-level laser therapy (LLLT) in human progressive-intensity running: effects on exercise performance, skeletal muscle status, and oxidative stress. Lasers Med Sci. 2012 Jan;27(1):231-6. doi: 10.1007/s10103-011-0955-5. Epub 2011 Jul 8.

  • de Brito Vieira WH, Bezerra RM, Queiroz RA, Maciel NF, Parizotto NA, Ferraresi C. Use of low-level laser therapy (808 nm) to muscle fatigue resistance: a randomized double-blind crossover trial. Photomed Laser Surg. 2014 Dec;32(12):678-85. doi: 10.1089/pho.2014.3812.

  • Vanin AA, Verhagen E, Barboza SD, Costa LOP, Leal-Junior ECP. Photobiomodulation therapy for the improvement of muscular performance and reduction of muscular fatigue associated with exercise in healthy people: a systematic review and meta-analysis. Lasers Med Sci. 2018 Jan;33(1):181-214. doi: 10.1007/s10103-017-2368-6. Epub 2017 Oct 31.

  • Zandbergen MA, Marotta L, Bulthuis R, Buurke JH, Veltink PH, Reenalda J. Effects of level running-induced fatigue on running kinematics: A systematic review and meta-analysis. Gait Posture. 2023 Jan;99:60-75. doi: 10.1016/j.gaitpost.2022.09.089. Epub 2022 Oct 12.

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The LLLT and sham devices were pre-coded as Conditions A and B by the manufacturer. Only the manufacturer retained the code linking each condition to the actual intervention. Participants, intervention personnel, investigators, and outcome assessors remained unaware of condition identity until completion of data analysis. The devices were covered during application to prevent visual identification of the assigned intervention.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized, two-period crossover design. Participants were assigned to one of two intervention sequences (LLLT followed by sham, or sham followed by LLLT), with a 2-week washout period between experimental visits.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 9, 2026

Study Start

February 17, 2025

Primary Completion

June 19, 2025

Study Completion

June 19, 2025

Last Updated

September 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made publicly available because of participant privacy and ethical considerations. De-identified data may be available from the corresponding author upon reasonable request, subject to applicable ethical and institutional restrictions.

Locations