Blood Flow Restricted Electrical Stimulation During Immobilisation

Investigating the Effect of Neuromuscular Electrical Stimulation and Blood Flow Restriction Training on Physiological Deconditioning During Unloading and Retraining

Following injury or surgery to a limb, it is often immobilised to allow tissue healing. Short periods of disuse cause loss of muscle size and strength and impaired mechanical properties of tendons, which leads to reduced function. Strategies to combat these deconditioning adaptations include neuromuscular electrical stimulation (NMES), however at present its effectiveness is limited. Recent research suggests that the effects of NMES can be augmented with blood flow restriction (BFR). At present, the effect of combining these two techniques on muscle function during limb immobilisation is unknown. Furthermore, the impact of BFR training during retraining following immobilisation is unknown.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrophy, Muscular; Atrophy, Disuse
• Intervention / Treatment: Other: Neuromuscular electrical stimulation with blood flow restriction

Detailed Description

Following injury or surgery to a limb, it is often immobilised to allow tissue healing. Short periods of disuse cause loss of muscle size and strength and impaired mechanical properties of tendons, which leads to reduced function. Strategies to combat these deconditioning adaptations include neuromuscular electrical stimulation (NMES), however at present its effectiveness is limited. Recent research suggests that the effects of NMES can be augmented with blood flow restriction (BFR). At present, the effect of combining these two techniques on muscle function during limb immobilisation is unknown. Furthermore, the impact of BFR training during retraining following immobilisation is unknown.

This study will examine the effectiveness and feasibility of a neuromuscular electrical stimulation and blood flow restriction protocol during a 7 day period of immobilisation. Multiple measures across several physiological systems will be obtained.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen Patterson, PhD; Email: Stephen.patterson@stmarys.ac.uk
• Study Contact Backup: Name: Luke Hughes, PhD; Phone Number: 4058 0208 240 4058; Email: Luke.hughes@stmarys.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Between the age of 18-55
• Non-smoker
• No previous history of cardiovascular, respiratory or neurological problems
• Not taking anticoagulant medication
• Injury-free in the 3 months prior to scheduled participation in the study.

Exclusion Criteria:

• Hypertension (<140/80)
• Metal work in-situ
• Blood diseases or clotting issues
• Injury or previous injury (<3 months prior to scheduled participation in the study)
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neuromuscular electrical stimulation with blood flow restriction; This is the intervention condition	Other: Neuromuscular electrical stimulation with blood flow restriction; Neuromuscular electrical stimulation with blood flow restriction
No Intervention: No intervention; This is the control condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maximal isometric strength via Biodex Dynamometer	Strength measure	Through study completion, an average of 1 year
Change in maximal isokinetic strength via Biodex Dynamometer	Strength measure	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in muscle endurance via Biodex Dynamometer	Endurance measure	Through study completion, an average of 1 year
Change in muscle morphology via 2D and 3D ultrasonography	Morphology measure	Through study completion, an average of 1 year
Change in muscle VO2 via near-infrared spectroscopy	VO2 measure	Through study completion, an average of 1 year
Change in blood markers via venous blood samples	Blood markers	Through study completion, an average of 1 year
Change in pressure pain thresholds via handheld allometry	Pain measure	Through study completion, an average of 1 year
Change in corticomotor excitability and inhibition, via transcranial magnetic stimulation	Corticospinal function	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: St Mary's University College

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: immobilisation; neuromuscular electrical stimulation; blood flow restriction
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Muscular Disorders, Atrophic
• Other Study ID Numbers: SMU-BFRImmob

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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