Feasibility of Assessing Muscle Displacement and Muscle Excursion on Muscle Fatigue, With and Without Preventive Strategies

NCT07102602 | Active Not Recruiting FDA Device

• 1 other identifier: 202410054DINE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Study Subjects: This study will recruit healthy males aged 18 to 35 who regularly exercise for at least 2.5 hours per week. Expected Number of Participants: 20. Methods and Procedures: This trial will be randomized into two groups, Groups A and B, who will undergo two isokinetic concentric exercise sessions (fatiguing exercise) separated by 15 days. Group A will first receive a fatigue prevention strategy (high-energy laser) followed by a placebo-controlled no-fatigue strategy 15 days later. Group B will first receive a placebo-controlled no-fatigue strategy followed by a fatigue prevention strategy (high-energy laser) 15 days later. The fatigue prevention strategy involves irradiating the quadriceps femoris with a 900-joule high-intensity laser therapy (3-watt output power for 5 minutes) before the isokinetic concentric exercise. The no-fatigue strategy (sham-controlled) involves irradiating the quadriceps femoris with a 0-joule high-energy laser (0-watt output power for 5 minutes) before the isokinetic concentric exercise. Muscle displacement, muscle excursion, as well as muscle electrophysiological changes, force output, and microcirculation parameters were measured before and after exercise to verify the feasibility of muscle displacement and migration for muscle fatigue assessment, and to further establish their impact and application value in muscle fatigue prevention strategies (high-intensity laser therapy).

Conditions

Muscle Fatigue

Outcome Measures

Primary Outcomes (1)

• Muscle displacement

  pre-fatigue (baseline), immediately post-fatigue, 5, 10, 20 minutes post-fatigue

Study Arms (2)

high intensity laser therapy

ACTIVE COMPARATOR

Device: high intensity laser therapy

sham laser therapy

SHAM COMPARATOR

Device: Sham laser therapy

Interventions

high intensity laser therapy DEVICE

The high-intensity laser used in this study is approved by the Ministry of Health and Welfare, Taiwan (No. 032670). It operates at a wavelength of 940 nm. For the active treatment (HILT), the laser delivers 900 joules to the quadriceps at a power output of 3 W for 5 minutes and is applied along the length of the quadriceps muscle

high intensity laser therapy

Sham laser therapy DEVICE

In the sham condition (SHAM), the output is set to 0 W for 5 minutes, resulting in no energy delivery.

sham laser therapy

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy male aged between 18 and 35 years who engage in regular physical activity for at least 2.5 hours per week

You may not qualify if:

• history of musculoskeletal injuries or lower limb muscle strains involving the dominant lower limb within the past six months
• history of surgical interventions on the dominant lower limb

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University College of Medicine

Taipei, Taipei city, 100, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 4, 2025
• Study Start: November 30, 2024
• Primary Completion: February 25, 2025
• Study Completion: November 30, 2025
• Last Updated: August 4, 2025

Record last verified: 2025-07

Locations

TW (1)