NCT05093985

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

1.9 years

First QC Date

September 20, 2021

Last Update Submit

October 13, 2021

Conditions

Atrophy, MuscularAtrophy, Disuse

Keywords

immobilisationblood flow restrictionneuromuscular electrical stimulation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Change in muscle endurance via Biodex Dynamometer

    Through study completion, an average of 1 year

  • Change in muscle morphology via 2D and 3D ultrasonography

    Through study completion, an average of 1 year

  • Change in muscle VO2 via near-infrared spectroscopy

    Through study completion, an average of 1 year

  • Change in blood markers via venous blood samples

    Through study completion, an average of 1 year

  • Change in pressure pain thresholds via handheld allometry

    Through study completion, an average of 1 year

  • +1 more secondary outcomes

Study Arms (2)

Neuromuscular electrical stimulation with blood flow restriction

EXPERIMENTAL

This is the intervention condition

Other: Neuromuscular electrical stimulation with blood flow restriction

No intervention

NO INTERVENTION

This is the control condition

Interventions

Neuromuscular electrical stimulation with blood flow restrictionOTHER

Neuromuscular electrical stimulation with blood flow restriction

Neuromuscular electrical stimulation with blood flow restriction

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Muscular AtrophyMuscular Disorders, Atrophic

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular Diseases

Central Study Contacts

Luke Hughes, PhD

CONTACT

0208 240 4058Luke.hughes@stmarys.ac.uk

Stephen Patterson, PhD

CONTACT

Stephen.patterson@stmarys.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2021

First Posted

October 26, 2021

Study Start

November 15, 2021

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

October 26, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share