Clinical trial NCT05093985: Blood Flow Restricted Electrical Stimulation During Immobilisation
Official title: Investigating the Effect of Neuromuscular Electrical Stimulation and Blood Flow Restriction Training on Physiological Deconditioning During Unloading and Retraining
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrophy, Muscular
Atrophy, Disuse
Keywords: immobilisation
blood flow restriction
neuromuscular electrical stimulation
Lead sponsor: St Mary's University College
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in maximal isometric strength via Biodex Dynamometer
timeFrame: Through study completion, an average of 1 year
measure: Change in maximal isokinetic strength via Biodex Dynamometer
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Change in muscle endurance via Biodex Dynamometer
timeFrame: Through study completion, an average of 1 year
measure: Change in muscle morphology via 2D and 3D ultrasonography
timeFrame: Through study completion, an average of 1 year
measure: Change in muscle VO2 via near-infrared spectroscopy
timeFrame: Through study completion, an average of 1 year
measure: Change in blood markers via venous blood samples
timeFrame: Through study completion, an average of 1 year
measure: Change in pressure pain thresholds via handheld allometry
timeFrame: Through study completion, an average of 1 year
measure: Change in corticomotor excitability and inhibition, via transcranial magnetic stimulation
timeFrame: Through study completion, an average of 1 year
Other outcomes:
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