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

NCT ID: NCT07102602

Last Updated: 2025-08-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2025-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

high intensity laser therapy

Group Type: ACTIVE_COMPARATOR

high intensity laser therapy

Intervention Type: 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

sham laser therapy

Group Type: SHAM_COMPARATOR

Sham laser therapy

Intervention Type: DEVICE

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

Interventions

high intensity laser therapy

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

Intervention Type: DEVICE

Sham laser therapy

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University College of Medicine

Taipei, Taipei city, Taiwan

Countries

Taiwan

Other Identifiers

202410054DINE

Identifier Type: -

Identifier Source: org_study_id