Blood Flow Restricted Electrical Stimulation During Immobilisation

Atrophy, Muscular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05093985
• Other study ID #: SMU-BFRImmob
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2021
• Source: St Mary's University College
• Contact: Luke Hughes, PhD
• Phone: 0208 240 4058
• Email: Luke.hughes[@]stmarys.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Atrophy, Disuse
• Atrophy, Muscular
• Muscular Atrophy
• Muscular Disorders, Atrophic

Intervention

Other:
• Neuromuscular electrical stimulation with blood flow restriction
Neuromuscular electrical stimulation with blood flow restriction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St Mary's University College

Outcome

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