Combining Resting Blood Flow Restriction with Neuromuscular Electrical Stimulation: Effects on Blood Lactate Levels and Lower Limb Muscle Function

January 20, 2025 updated by: Hyunjoong Kim
The current research landscape shows studies indicating increased muscle strength and hypertrophy through neuromuscular electrical stimulation combined with blood flow restriction. However, there is a lack of research specifically on the effects of this combination during rest periods. Therefore, the primary objective of this study is to investigate the impact of resting blood flow restriction training combined with neuromuscular electrical stimulation on blood lactate levels and changes in lower limb muscle function in healthy male adults.

Study Overview

Status

Status

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

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 (Actual)

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.
12

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.

Study Locations

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:

  • Healthy adult males in their 20s,
  • Individuals who answered less than one item on the PAR-Q (Physical Activity Readiness Questionnaire),
  • Participants who consented to the use and publication of their physical function evaluation data and expressed a desire to participate in the exercise experiment.

Exclusion Criteria:

  • Individuals with severe hypertension (blood pressure above 170/110 mmHg),
  • Individuals with a history of deep venous thrombosis,
  • Individuals with endothelial dysfunction,
  • Individuals with peripheral vascular disease,
  • Individuals with one or more of the following conditions: diabetes, infection, cancer,
  • Participants who expressed a desire to withdraw during the study period or whose participation rate was below 80% were excluded from the study.

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: Non-Randomized
  • Interventional Model: Single Group 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.
Active Comparator: rest-Blood Flow Restriction plus Neuromuscular Electrical Stimulation
Device: Blood Flow Restriction
The study participants were instructed to rest quietly in a seated position for 10 minutes. During the last 3 minutes of the resting period, upper arm blood pressure was measured twice using an automatic blood pressure monitor (BP170, InBody, Korea). The blood flow restriction cuffs (BFR Therapy Cuff, BFR Therapy Co., USA) - measuring 5cm in width and 60cm in length - were applied to the upper third of the thigh on both legs. To maintain consistency in measurements, the distance from the proximal part of the kneecap to the distal edge of the cuff was measured. A Capillary Reaction Time (CRT) test was used to assess the appropriateness of the cuff pressure; this involved applying thumb pressure to the quadriceps muscle after cuff application and timing how long it took for the skin color to return to normal.
Device: Neuromuscular Electrical Stimulation
Neuromuscular Electrical Stimulation (NMES) was applied five times a week for one week using a four-channel stimulator (Compex Physio, Chattanooga, Switzerland). The stimulation protocol was set to a frequency of 35Hz, with electrodes attached to the vastus lateralis and vastus medialis muscles. The therapist adjusted the intensity and alternating output of the electrodes selectively to facilitate the squat exercises required during the intervention. During the stimulation period, participants were engaged in a squat exercise program, with the total duration of stimulation being 10 minutes.
Active Comparator: rest-Blood Flow Restriction
Device: Blood Flow Restriction
The study participants were instructed to rest quietly in a seated position for 10 minutes. During the last 3 minutes of the resting period, upper arm blood pressure was measured twice using an automatic blood pressure monitor (BP170, InBody, Korea). The blood flow restriction cuffs (BFR Therapy Cuff, BFR Therapy Co., USA) - measuring 5cm in width and 60cm in length - were applied to the upper third of the thigh on both legs. To maintain consistency in measurements, the distance from the proximal part of the kneecap to the distal edge of the cuff was measured. A Capillary Reaction Time (CRT) test was used to assess the appropriateness of the cuff pressure; this involved applying thumb pressure to the quadriceps muscle after cuff application and timing how long it took for the skin color to return to normal.
Active Comparator: Squat Exercise
Behavioral: Squat exercise
In this study, the squat exercise was performed in four sets. Participants were instructed to position their feet shoulder-width apart and educated to squat in such a way that their knees did not extend beyond their toes. To ensure consistency in performing the squat at the same angle, a mark was made on the wall at the pelvic height during a 90° squat. This allowed participants to perform squats at the same height. The exercise was conducted under the guidance of a physical therapist with five years of clinical experience.

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
Blood lactate
Time Frame: Immediate change from baseline after intervention
Lactate levels were measured using the Accutrend Plus (Roche, Germany). A small amount of whole blood was collected from the participants for blood lactate concentration analysis. The procedure involved the finger-prick method, where the tip of the right index finger was disinfected with an alcohol swab. Then, a lancet prepared for this purpose was used to obtain a small sample of capillary blood from the disinfected area. The collected blood was then applied to lactate strips, and the blood lactate analyzer (Accutrend Plus, Roche, Germany) provided the lactate level readings within 60 seconds.
Immediate change from baseline after intervention

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.
Hyunjoong Kim

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.
December 30, 2023

Primary Completion (Actual)

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.
January 11, 2024

Study Completion (Actual)

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.
January 30, 2024

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).
December 23, 2023

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 23, 2023

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.
January 9, 2024

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.
January 20, 2025

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.
January 1, 2025

More Information

Terms related to this study

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.
  • 1041223-202309-HR-30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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