HealthyNCT06196099
Combining Resting Blood Flow Restriction with Neuromuscular Electrical Stimulation: Effects on Blood Lactate Levels and Lower Limb Muscle Function
A study testing Blood Flow Restriction, Neuromuscular Electrical Stimulation and Squat exercise in people with Healthy, run by Hyunjoong Kim at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Blood Flow Restriction, Neuromuscular Electrical Stimulation and Squat exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Dec 2023to 30 Jan 2024
- 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 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy
- Being tested
- Blood Flow Restriction, Neuromuscular Electrical Stimulation, Squat exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow RestrictionDevice
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.
Neuromuscular Electrical StimulationDevice
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.
Squat exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| rest-Blood Flow Restriction plus Neuromuscular Electrical Stimulation | Active comparator | Not described Receives: Device: Blood Flow Restriction; Device: Neuromuscular Electrical Stimulation |
| rest-Blood Flow Restriction | Active comparator | Not described Receives: Device: Blood Flow Restriction |
| Squat Exercise | Active comparator | Not described Receives: Behavioral: Squat exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lactate
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.
Measured: Immediate change from baseline after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start30 Dec 2023
- Primary completion11 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyunjoong Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hyunjoong Kim, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196099
- Sponsor's protocol ID
- 1041223-202309-HR-30
- Status last verified
- Jan 2025
- First submitted
- 23 Dec 2023
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Resting Blood Flow Restriction with Neuromuscular Electrical Stimulation: Effects on Blood Lactate Levels and Lower Limb Muscle Function
- ClinicalTrials.gov ID
- NCT06196099
- Acronym / sponsor ID
- 1041223-202309-HR-30
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hyunjoong KimUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 9 Jan 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rest-Blood Flow Restriction plus Neuromuscular Electrical Stimulation | Active comparator | Device: Blood Flow Restriction, Device: Neuromuscular Electrical Stimulation |
| rest-Blood Flow Restriction | Active comparator | Device: Blood Flow Restriction |
| Squat Exercise | Active comparator | Behavioral: Squat exercise |
Who may qualify
- Ages
- 20 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
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 |
|---|---|---|
| Blood Flow RestrictionThe 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 | rest-Blood Flow Restriction, rest-Blood Flow Restriction plus Neuromuscular Electrical Stimulation |
| Neuromuscular Electrical StimulationNeuromuscular 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. | Device | rest-Blood Flow Restriction plus Neuromuscular Electrical Stimulation |
| Squat exerciseIn 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. | Behavioural | Squat Exercise |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: Yes
Related trials for Healthy
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction, Neuromuscular Electrical Stimulation and Squat exercise in people with Healthy, run by Hyunjoong Kim at 1 site in South Korea.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 23 Jan 2025. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood lactate (time frame: Immediate change from baseline after intervention). 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 23 Jan 2025.