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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
St Mary's University College
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 20, 2021
    Last Updated
    October 13, 2021
    Sponsor
    St Mary's University College
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    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

    Learn more about this trial

    Blood Flow Restricted Electrical Stimulation During Immobilisation

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