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

December 16, 2024 updated by: National Cheng-Kung University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ing-Shiou Hwang, PhD
  • Phone Number: 5024 +886 62353535
  • Email: ensureh@gmail.com

Study Contact Backup

Study Locations

  • Taiwan
      • Tainan, Taiwan
        • Recruiting
        • National Chen Kong University Hospital, Tainan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Myoton
Time Frame: before training, 1week of training, 2 weeks of training, at the end of 3 weeks training
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
Time Frame: before training, 1week of training, 2 weeks of training, at the end of 3 weeks training
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
Time Frame: before training, at the end of 3 weeks training
Record muscle activity during contraction
before training, at the end of 3 weeks training
Dynamometer System
Time Frame: before training, 1week of training, 2 weeks of training, at the end of 3 weeks training
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cheng-Kung University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ing-Shiou Hwang, PhD, NCKU, Institute of Allied Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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