The Enhancement Effect of Low-Level Laser Therapy for Muscle Training with Combined NMES and BFR

The Enhancement Effect of Low-Level Laser Therapy for Muscle Training with Combined Neuromuscular Electrical Stimulation and Blood Flow Restriction

Blood flow restriction training (BFR) with neuromuscular stimulation (NMES) is employed for individuals with limited mobility and joint issues. However, this approach is highly susceptible to muscle fatigue, despite its potential beneficial effects on muscle strength. Recently, there has been growing interest in using low-level laser therapy (LLLT) to address muscle fatigue. LLLT, known for improving microcirculation and mitochondrial function, shows promise in alleviating enhanced muscle fatigue associated with combined BFR and NMES training. Despite these positive effects, there is limited knowledge about the short-term training impact of combined BFR and NMES with LLLT preconditioning. This project aims to investigate whether the photobiomodulation effects of LLLT could further enhance the training benefits of combined BFR and NMES. The study will employ an integrated analysis of decomposition surface EMG, EEG, and mechanomyogram to explore the behavior and neuromuscular mechanisms underlying the training benefits. If additional benefits are identified, LLLT pre-conditioning is recommended to enhance the use of combined BFR and NMES.

Study Overview

• Status: Recruiting
• Conditions: Muscle Strength; Laser Therapy, Low-Level; Neuromuscular Electrical Stimulation (NMES); Blood Flow Restriction Therapy
• Intervention / Treatment: Device: Low Level Laser Therapy; Device: blood flow restriction; Device: Neuromuscular Electrical Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ing-Shiou Hwang, PhD; Phone Number: 5024 +886 62353535; Email: ensureh@gmail.com
• Study Contact Backup: Name: Pei-Fen Li, Master; Phone Number: 5024 +886 62353535; Email: abbylee52034@gmail.com

Study Locations

• Taiwan
  • Tainan, Taiwan
    • Recruiting
    • National Chen Kong University Hospital, Tainan
    • Contact: Ing-Shiou Hwang, PhD; Phone Number: 5932 88662353535; Email: ensureh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy adults aged 20-40, without a diagnosis of cardiovascular or neuromusculoskeletal diseases.
2. Normal vision range after visual correction.

Exclusion Criteria:

1. Exclude students who have a teacher-student relationship with the principal investigator to ensure the participants' autonomy.
2. History of brain injury, stroke, spinal cord injury, or other neuromuscular-related conditions.
3. Contraindications for laser therapy: pregnancy, malignant tumor tissues, bleeding areas, and photosensitive skin regions.
4. Presence of any contraindications for blood flow restriction training, such as a history of injury or strain in the non-dominant arm's biceps, deep vein thrombosis or venous occlusion in the non-dominant arm, acute unstable fractures in the non-dominant arm, acute regional infections in the non-dominant arm, severe peripheral arterial occlusive disease in the non-dominant arm, complete lymphatic obstruction in the non-dominant arm, and edema due to acute pulmonary edema or congestive heart failure in the non-dominant arm.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LLLT+BFR+NMES; LLLT: low-level laser therapy BFR: blood flow restriction NMES:neuromuscular Electrical Stimulation 35 min/time, 3 times/weeks, 3 weeks	Device: Low Level Laser Therapy; Low-level laser therapy can increase cellular energy production, making it useful as a pre-conditioning treatment to prevent muscle contraction fatigue or as a post-contraction therapy to accelerate fatigue recovery.; Device: blood flow restriction; Its advantage is that during training, it can surpass the "overload principle," allowing for effective muscle cross-sectional area growth with relatively light weight training (20%-50% of 1RM or 20%-40% of MVC).; Device: Neuromuscular Electrical Stimulation; It is a strength training method that uses electrical currents to stimulate nerve and muscle activation, helping to maintain muscle mass, increase blood flow, and slow down or prevent muscle atrophy.
Experimental: BFR+NMES; BFR: blood flow restriction NMES:Neuromuscular Electrical Stimulation 35 min/time, 3 times/weeks, 3 weeks	Device: blood flow restriction; Its advantage is that during training, it can surpass the "overload principle," allowing for effective muscle cross-sectional area growth with relatively light weight training (20%-50% of 1RM or 20%-40% of MVC).; Device: Neuromuscular Electrical Stimulation; It is a strength training method that uses electrical currents to stimulate nerve and muscle activation, helping to maintain muscle mass, increase blood flow, and slow down or prevent muscle atrophy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myoton	Non-dominant hand extensor digitorum muscle belly parameters of static mechanical properties of muscles (Tone, Stiffness, Relaxation, Creep, etc.)	before training, 1week of training, 2 weeks of training, at the end of 3 weeks training
Mechanomyogram	Recording of extensor digitorum muscle microshock waves during contraction	before training, 1week of training, 2 weeks of training, at the end of 3 weeks training
Multi-electrode surface EMG	Record muscle activity during contraction	before training, at the end of 3 weeks training
Dynamometer System	Measurement to track the degree of force applied by a non-dominant hand.	before training, 1week of training, 2 weeks of training, at the end of 3 weeks training

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Investigators: Study Chair: Ing-Shiou Hwang, PhD, NCKU, Institute of Allied Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Training; Muscle strength; Blood flow restriction; Neuromuscular electrical stimulation; Low-level laser Therapy
• Other Study ID Numbers: A-ER-113-089

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
• product manufactured in and exported from the U.S.: No