Effect of Neuromuscular Electrical Stimulation Combined With Blood Flow Restriction on Muscular and Cardiovascular Function

NCT03662555 | Unknown

• 1 other identifier: Stmarys
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Neuromuscular electrical stimulation (NMES) has recently been combined with blood flow restriction (BFR) in controlled trials and has shown increased muscular strength and size compared with NMES and BFR on their own. However, none have used BFR pressures previously recommended. The first study of my Ph.D. found 40% and 80% BFR pressures to induce acute fatigue and muscle swelling. However, 80% caused higher ratings of pain and perceived exertion. The present study will determine whether NMES combined with either 40% or 80% BFR causes greater structural muscular adaptations and is perceptually easier after 6 weeks of training.

Conditions

Muscle Weakness; Muscle Atrophy

Outcome Measures

Primary Outcomes (2)

• Quadriceps volume and muscle architecture (3D Ultrasound)

  Muscle volume of the vastus lateralis and skeletal muscle architecture will be assessed by ultrasound technique (Telemed LogicScan 128 EXT-1Z). Measurement of fascicle length and pennation angle will be acquired at mid-belly, in the mid-sagittal plane.

  8 weeks

• Knee extension isometric, eccentric, concentric and endurance strength (Cybex)

  Maximal isometric, eccentric and concentric strength of the quadricep muscles will be measured using the same isokinetic dynamometer to assess peak force measurements (Cybex). This digital strain gauge dynamometer displays the force measurement to the nearest 0.1 N. Prior to each measurement, the instrument will be calibrated per the manufacturer's instructions and specifications. The individuals will be seated in a comfortable position with the backrest angled at 100˚ to the seat without shoes or orthotic device on. Maximal voluntary isometric contraction (MVIC) for the quadriceps will tested at 60 degrees from full extension using a goniometer (19-21), and the shin pad positioned 2 cm above the lateral malleolus of the fibula attached to a load cell (22).

  8 weeks

Secondary Outcomes (3)

• Voluntary activation

  8 weeks

• Near-infrared spectroscopy

  8 weeks

• Blood pressure

  8 weeks

Study Arms (3)

NMES and BFR (80%)

EXPERIMENTAL

Group 1, participants will undergo NMES and BFR (80% pressure) applied to the quadriceps for 25 min.

Device: Neuromuscular electrical stimulation

NMES and BFR (40%)

EXPERIMENTAL

Group 2, participants will undergo NMES and BFR (40% pressure) applied to the quadriceps for 25 min.

Device: Neuromuscular electrical stimulation

NMES alone

ACTIVE COMPARATOR

Group 3, participants will undergo NMES applied to the quadriceps for 25 min.

Device: Neuromuscular electrical stimulation

Interventions

Neuromuscular electrical stimulation DEVICE

Neuromuscular electrical simulation (NMES) Two self-adhesive electrodes (2 mm thick) will be placed over the rectus femoris, vastus medialis and vastus lateralis muscles. The electrodes will be placed on the motor points of each muscle. The stimulator discharges biphasic rectangular pulses. The stimulation frequency and duty cycle will be 50 Hz and 5 s of stimulation followed by a 5 s pause for each rep. The intensity of electrical flow will be at each subject's maximum that they can tolerate. The stimulation will be for 5 x 5 min sets with 1 min rest between sets. Blood flow restriction A handheld Doppler probe (Hi-Dop) will detect their auscultatory and visual pulse using the doppler's screen. The cuff will be inflated initially up to their systolic blood pressure and then incrementally by 10 mmHg until no auscultatory or visual pulse is detected. A percentage of 40% or 80% of each subject's LOP will then be used during the BFR conditions.

Also known as: Blood flow restriction

NMES alone; NMES and BFR (40%); NMES and BFR (80%)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged between 18 and 45 years old

You may not qualify if:

• History of lower extremity surgery, traumatic injuries to the ankle, knee, hip, pelvis and lower back
• Current musculoskeletal condition
• High blood pressure
• Cardiovascular pathology

Sponsors & Collaborators

• St. Mary's University, Twickenham: lead

MeSH Terms

Conditions

Muscle Weakness; Muscular Atrophy

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Atrophy; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Model Details: In a multi-arm parallel randomised controlled trial design. The randomisation scheme will be generated via online software (http://www.randomization.com). Participants will be recruited to 6 weeks of training, 3 sessions a week and randomised to one of three groups. Group 1, participants will undergo NMES and BFR (80% pressure) applied to the quadriceps for 25 min. Group 2, participants will undergo NMES and BFR (40% pressure) applied to the quadriceps for 25 min. Group 3, participants will undergo NMES alone (Control) applied to the quadriceps for 25 min.

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 7, 2018
• Study Start: September 26, 2018
• Primary Completion: July 31, 2019
• Study Completion: September 30, 2019
• Last Updated: September 12, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share