MedDataX Logo

Blood Flow Restricted Electrical Stimulation During Immobilisation

NCT ID: NCT05093985

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2023-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrophy, Muscular Atrophy, Disuse

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

immobilisation blood flow restriction neuromuscular electrical stimulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Neuromuscular electrical stimulation with blood flow restriction

This is the intervention condition

Group Type EXPERIMENTAL

Neuromuscular electrical stimulation with blood flow restriction

Intervention Type OTHER

Neuromuscular electrical stimulation with blood flow restriction

No intervention

This is the control condition

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neuromuscular electrical stimulation with blood flow restriction

Neuromuscular electrical stimulation with blood flow restriction

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St Mary's University College

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Luke Hughes, PhD

Role: CONTACT

Phone: 0208 240 4058

Email: [email protected]

Stephen Patterson, PhD

Role: CONTACT

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SMU-BFRImmob

Identifier Type: -

Identifier Source: org_study_id