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Muscle WeaknessNCT03662555

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

A study testing Neuromuscular electrical stimulation in people with Muscle Weakness and Muscle Atrophy, run by St. Mary's University, Twickenham.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Muscle Weakness, Muscle Atrophy
What is being tested?
Neuromuscular electrical stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
26 Sep 2018to 30 Sep 2019
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 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adults aged between 18 and 45 years old

Who cannot join

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

About this study

Official title: Effect of Neuromuscular Electrical Stimulation Combined With Varying Degrees of Blood Flow Restriction on Muscular and Cardiovascular Function

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.

Read the detailed description

Laboratory testing will take place on 28 separate occasions, 2 familiarisation, 8 testing and 18 intervention sessions. The first session (FAM 1) will serve as a familiarisation trial to the NMES protocol, BFR stimulus and strength testing. It will be conducted 10-14 days prior to the intervention period. The second session (FAM 2) will serve as a second familiarisation trial to the NMES protocol, BFR stimulus and strength testing. This session will take place 7 days prior to the beginning of the intervention period and will serve as a standardised control period prior to the main testing. The third session (PRE) will take place 1 day prior the start of the intervention period and all future sessions will consist of strength, muscle and cardiovascular function outcome measures. The fourth session (MID) will take place the morning following 3 weeks of training. The fifth session (POST1) will take place 48 hours following 6 weeks of training. There will also be post testing sessions after three days (POST2), one week (POST3) and two weeks post intervention (POST4) to assess detraining. Participants will be provided with protein supplementation after every training session. All strength, muscle and hemodynamic measurements will be conducted at St Marys University by Paul Head. Supplements should be avoided for 72 hours prior to experimental measures and throughout the intervention period. All repeated measures will be performed at a similar time of day (± 1 h).

Being tested
Neuromuscular electrical stimulation
Medical subject headings
Muscle Weakness, Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular electrical stimulationDevice

    Also called Blood flow restriction

    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.

Study groups in NCT03662555
Study groupRoleWhat they receive
NMES and BFR (80%)ExperimentalGroup 1, participants will undergo NMES and BFR (80% pressure) applied to the quadriceps for 25 min.
Receives: Device: Neuromuscular electrical stimulation
NMES and BFR (40%)ExperimentalGroup 2, participants will undergo NMES and BFR (40% pressure) applied to the quadriceps for 25 min.
Receives: Device: Neuromuscular electrical stimulation
NMES aloneActive comparatorGroup 3, participants will undergo NMES applied to the quadriceps for 25 min.
Receives: Device: Neuromuscular electrical stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 weeks

  2. 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).

    Measured: 8 weeks

Secondary outcomes (3)

  1. Voluntary activation

    The percent of voluntary activation (%VA) will be estimated using the twitch interpolation protocol (25). Doublet stimuli were administered to the femoral nerve approximately 200-300 ms into the MVC. A second doublet will be applied approximately 3 s after the cessation of the MVC at rest (25). The stimuli were rectangular pulses of 200 ls duration and will be delivered using a high-voltage (maximal voltage = 400 V) constant-current stimulator (Digitimer DS7AH, Herthfordshire, UK).

    Measured: 8 weeks

  2. Near-infrared spectroscopy

    Following 10 min of supine rest a near-infrared spectroscopy (NIRS) optode (Portamon, Artinis medical systems) was placed on the vastus lateralis and secured with an elastic bandage (Tiger Tear, Hampshire, United Kingdom) to prevent movement and covered with an optically dense black material to minimize the intrusion of extraneous light. This protocol was used to characterize the recovery of m˙VO2 and has been shown to be reliable by our group and others (28-30). NIRS will be assessed PRE, MID and POST1, 2, 3 and 4.

    Measured: 8 weeks

  3. Blood pressure

    A blood pressure cuff (Omron) will be placed around the subject's dominant arm and tested after 5 mins of supine rest and then immediately post each intervention session and at POST testing. To assess acute changes in systolic and diastolic blood pressure. Two readings will be taken and if they have a difference of >5 a third reading will be taken and the average recorded (27).

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2018
  2. Study start26 Sep 2018 (estimated)
  3. Primary completion31 Jul 2019 (estimated)
  4. Study completion30 Sep 2019 (estimated)

Resources

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
Model description
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.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03662555
Sponsor's protocol ID
Stmarys
Status last verified
Sep 2018
First submitted
5 Sep 2018
Last updated
12 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular electrical stimulation in people with Muscle Weakness and Muscle Atrophy, run by St. Mary's University, Twickenham.

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 1 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 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Quadriceps volume and muscle architecture (3D Ultrasound) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03662555.

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 12 Sep 2018.

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