Blood Flow Restriction TherapyNCT06739148
The Enhancement Effect of Low-Level Laser Therapy for Muscle Training with Combined NMES and BFR
A study testing Low Level Laser Therapy, blood flow restriction and Neuromuscular Electrical Stimulation in people with Blood Flow Restriction Therapy and Neuromuscular Electrical Stimulation (NMES), run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Flow Restriction Therapy, Neuromuscular Electrical Stimulation (NMES), Laser Therapy, Low-Level
- What is being tested?
- Low Level Laser Therapy, blood flow restriction and Neuromuscular Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 20-40, without a diagnosis of cardiovascular or neuromusculoskeletal diseases.
- Normal vision range after visual correction.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Chen Kong University Hospital, Tainan
Tainan
Ing-Shiou Hwang, PhD, 88662353535 ext. 5932, ensureh@gmail.com
About this study
Official title: 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.
- Conditions
- Blood Flow Restriction Therapy, Neuromuscular Electrical Stimulation (NMES), Laser Therapy, Low-Level, Muscle Strength
- Being tested
- Low Level Laser Therapy, blood flow restriction, Neuromuscular Electrical Stimulation
- Keywords
- Muscle strength, Training, Low-level laser Therapy, Blood flow restriction, Neuromuscular electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyDevice
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.
blood flow restrictionDevice
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).
Neuromuscular Electrical StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Low Level Laser Therapy; Device: blood flow restriction; Device: Neuromuscular Electrical Stimulation |
| BFR+NMES | Experimental | BFR: blood flow restriction NMES:Neuromuscular Electrical Stimulation
35 min/time, 3 times/weeks, 3 weeks Receives: Device: blood flow restriction; Device: Neuromuscular Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myoton
Non-dominant hand extensor digitorum muscle belly parameters of static mechanical properties of muscles (Tone, Stiffness, Relaxation, Creep, etc.)
Measured: 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
Measured: 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
Measured: before training, at the end of 3 weeks training
Dynamometer System
Measurement to track the degree of force applied by a non-dominant hand.
Measured: before training, 1week of training, 2 weeks of training, at the end of 3 weeks training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Oct 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Flow Restriction TherapyStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ing-Shiou Hwang, PhD, Study chair, NCKU, Institute of Allied Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739148
- Sponsor's protocol ID
- A-ER-113-089
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Enhancement Effect of Low-Level Laser Therapy for Muscle Training with Combined Neuromuscular Electrical Stimulation and Blood Flow Restriction
- ClinicalTrials.gov ID
- NCT06739148
- Acronym / sponsor ID
- A-ER-113-089
- Conditions
- Blood Flow Restriction Therapy, Neuromuscular Electrical Stimulation (NMES), Laser Therapy, Low-Level, Muscle Strength
- Keywords
- Muscle strength, Training, Low-level laser Therapy, Blood flow restriction, Neuromuscular electrical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLLT+BFR+NMES | Experimental | Device: Low Level Laser Therapy, Device: blood flow restriction, Device: Neuromuscular Electrical StimulationLLLT: low-level laser therapy BFR: blood flow restriction NMES:neuromuscular Electrical Stimulation 35 min/time, 3 times/weeks, 3 weeks |
| BFR+NMES | Experimental | Device: blood flow restriction, Device: Neuromuscular Electrical StimulationBFR: blood flow restriction NMES:Neuromuscular Electrical Stimulation 35 min/time, 3 times/weeks, 3 weeks |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adults aged 20-40, without a diagnosis of cardiovascular or neuromusculoskeletal diseases.
- Normal vision range after visual correction.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Level Laser TherapyLow-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 | LLLT+BFR+NMES |
| blood flow restrictionIts 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 | BFR+NMES, LLLT+BFR+NMES |
| Neuromuscular Electrical StimulationIt 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. | Device | BFR+NMES, LLLT+BFR+NMES |
Primary outcome
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.)
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
Multi-electrode surface EMG
Time frame: before training, at the end of 3 weeks training
Record muscle activity during contraction
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Blood Flow Restriction Therapy
Active, not recruiting
Different Levels of Blood Flow Restriction Versus Moderate Intensity Exercises in Patients With Knee Osteoarthritis
Knee Osteoarthritis, Blood Flow Restriction Therapy
Active, not recruiting
Project Tendura: The Impact of Blood Flow Restriction Resistance Training (BFR-RT) in Patients With Achilles Tendon Rupture (ATR) Repair
Achilles Tendon Rupture, Blood Flow Restriction Therapy
Recruiting
Evaluating the Efficacy of Blood Flow Restriction Therapy in a Randomized Clinical Trial for Postoperative Rehabilitation Following Ankle Ligament Reconstruction
Ankle Reconstruction, Blood Flow Restriction Therapy
Recruiting
Optimizing Rehabilitation After Achilles Tendon Rupture Repair: The Role of Blood Flow Restriction Training in Tendon and Muscle Recovery
Achilles Tendon Rupture, Blood Flow Restriction Therapy
Recruiting
Blood Flow Restriction Training For The Treatment Of Lateral Epicondylopathy
Elbow Tendinopathy, Elbow, Tennis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ing-Shiou Hwang, PhD study chair
NCKU, Institute of Allied Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy, blood flow restriction and Neuromuscular Electrical Stimulation in people with Blood Flow Restriction Therapy and Neuromuscular Electrical Stimulation (NMES), run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ing-Shiou Hwang, PhD (+886 62353535 ext. 5024, ensureh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myoton (time frame: before training, 1week of training, 2 weeks of training, at the end of 3 weeks training). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.