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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06196099
• Other study ID #: 1041223-202309-HR-30
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 30, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: January 2024
• Source: Sahmyook University
• Contact: Gwangsoo Kim, BSc
• Phone: +82-10-4140-7104
• Email: anemd9191[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: January 30, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
Korea, Republic of	Honam University	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
Hyunjoong Kim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediate change from baseline after intervention