NCT06739148

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

December 18, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

September 12, 2024

Last Update Submit

December 16, 2024

Conditions

Keywords

Muscle strengthTrainingLow-level laser TherapyBlood flow restrictionNeuromuscular electrical stimulation

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

LLLT+BFR+NMES

EXPERIMENTAL

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 TherapyDevice: blood flow restrictionDevice: Neuromuscular Electrical Stimulation

BFR+NMES

EXPERIMENTAL

BFR: blood flow restriction NMES:Neuromuscular Electrical Stimulation 35 min/time, 3 times/weeks, 3 weeks

Device: blood flow restrictionDevice: Neuromuscular Electrical Stimulation

Interventions

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.

LLLT+BFR+NMES

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).

BFR+NMESLLLT+BFR+NMES

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.

BFR+NMESLLLT+BFR+NMES

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Exclude students who have a teacher-student relationship with the principal investigator to ensure the participants\' autonomy.
  • History of brain injury, stroke, spinal cord injury, or other neuromuscular-related conditions.
  • Contraindications for laser therapy: pregnancy, malignant tumor tissues, bleeding areas, and photosensitive skin regions.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Chen Kong University Hospital, Tainan

Tainan, Taiwan

RECRUITING

MeSH Terms

Interventions

Low-Level Light TherapyBlood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapyExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CarePhysical Therapy Modalities

Study Officials

  • Ing-Shiou Hwang, PhD

    NCKU, Institute of Allied Health Sciences

    STUDY CHAIR

Central Study Contacts

Ing-Shiou Hwang, PhD

CONTACT

Pei-Fen Li, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2024

First Posted

December 18, 2024

Study Start

October 1, 2024

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

December 18, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations