Blood Flow Restricted Electrical Stimulation During Immobilisation
Primary Purpose
Atrophy, Muscular, Atrophy, Disuse
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation with blood flow restriction
Sponsored by
About this trial
This is an interventional basic science trial for Atrophy, Muscular focused on measuring immobilisation, blood flow restriction, neuromuscular electrical stimulation
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Neuromuscular electrical stimulation with blood flow restriction
No intervention
Arm Description
This is the intervention condition
This is the control condition
Outcomes
Primary Outcome Measures
Change in maximal isometric strength via Biodex Dynamometer
Strength measure
Change in maximal isokinetic strength via Biodex Dynamometer
Strength measure
Secondary Outcome Measures
Change in muscle endurance via Biodex Dynamometer
Endurance measure
Change in muscle morphology via 2D and 3D ultrasonography
Morphology measure
Change in muscle VO2 via near-infrared spectroscopy
VO2 measure
Change in blood markers via venous blood samples
Blood markers
Change in pressure pain thresholds via handheld allometry
Pain measure
Change in corticomotor excitability and inhibition, via transcranial magnetic stimulation
Corticospinal function
Full Information
NCT ID
NCT05093985
First Posted
September 20, 2021
Last Updated
October 13, 2021
Sponsor
St Mary's University College
1. Study Identification
Unique Protocol Identification Number
NCT05093985
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2021 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St Mary's University College
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy, Muscular, Atrophy, Disuse
Keywords
immobilisation, blood flow restriction, neuromuscular electrical stimulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neuromuscular electrical stimulation with blood flow restriction
Arm Type
Experimental
Arm Description
This is the intervention condition
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
This is the control condition
Intervention Type
Other
Intervention Name(s)
Neuromuscular electrical stimulation with blood flow restriction
Intervention Description
Neuromuscular electrical stimulation with blood flow restriction
Primary Outcome Measure Information:
Title
Change in maximal isometric strength via Biodex Dynamometer
Description
Strength measure
Time Frame
Through study completion, an average of 1 year
Title
Change in maximal isokinetic strength via Biodex Dynamometer
Description
Strength measure
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Change in muscle endurance via Biodex Dynamometer
Description
Endurance measure
Time Frame
Through study completion, an average of 1 year
Title
Change in muscle morphology via 2D and 3D ultrasonography
Description
Morphology measure
Time Frame
Through study completion, an average of 1 year
Title
Change in muscle VO2 via near-infrared spectroscopy
Description
VO2 measure
Time Frame
Through study completion, an average of 1 year
Title
Change in blood markers via venous blood samples
Description
Blood markers
Time Frame
Through study completion, an average of 1 year
Title
Change in pressure pain thresholds via handheld allometry
Description
Pain measure
Time Frame
Through study completion, an average of 1 year
Title
Change in corticomotor excitability and inhibition, via transcranial magnetic stimulation
Description
Corticospinal function
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luke Hughes, PhD
Phone
0208 240 4058
Ext
4058
Email
Luke.hughes@stmarys.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Patterson, PhD
Email
Stephen.patterson@stmarys.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
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Blood Flow Restricted Electrical Stimulation During Immobilisation
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