Atrophy, MuscularNCT05093985
Blood Flow Restricted Electrical Stimulation During Immobilisation
A study testing Neuromuscular electrical stimulation with blood flow restriction in people with Atrophy, Muscular and Atrophy, Disuse, run by St Mary's University College.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophy, Muscular, Atrophy, Disuse
- What is being tested?
- Neuromuscular electrical stimulation with blood flow restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2021to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Stephen Patterson, PhD contact
About this study
Official title: Investigating the Effect of Neuromuscular Electrical Stimulation and Blood Flow Restriction Training on Physiological Deconditioning During Unloading and Retraining
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.
Read the 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.
- Conditions
- Atrophy, Muscular, Atrophy, Disuse
- Being tested
- Neuromuscular electrical stimulation with blood flow restriction
- Keywords
- immobilisation, blood flow restriction, neuromuscular electrical stimulation
- Medical subject headings
- Muscular Atrophy, Muscular Disorders, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulation with blood flow restrictionOther
Neuromuscular electrical stimulation with blood flow restriction
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular electrical stimulation with blood flow restriction | Experimental | This is the intervention condition Receives: Other: Neuromuscular electrical stimulation with blood flow restriction |
| No intervention | No intervention | This is the control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal isometric strength via Biodex Dynamometer
Strength measure
Measured: Through study completion, an average of 1 year
Change in maximal isokinetic strength via Biodex Dynamometer
Strength measure
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Change in muscle endurance via Biodex Dynamometer
Endurance measure
Measured: Through study completion, an average of 1 year
Change in muscle morphology via 2D and 3D ultrasonography
Morphology measure
Measured: Through study completion, an average of 1 year
Change in muscle VO2 via near-infrared spectroscopy
VO2 measure
Measured: Through study completion, an average of 1 year
Change in blood markers via venous blood samples
Blood markers
Measured: Through study completion, an average of 1 year
Change in pressure pain thresholds via handheld allometry
Pain measure
Measured: Through study completion, an average of 1 year
Change in corticomotor excitability and inhibition, via transcranial magnetic stimulation
Corticospinal function
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start15 Nov 2021 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophy, MuscularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Mary's University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093985
- Sponsor's protocol ID
- SMU-BFRImmob
- Status last verified
- Oct 2021
- First submitted
- 20 Sep 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Neuromuscular Electrical Stimulation and Blood Flow Restriction Training on Physiological Deconditioning During Unloading and Retraining
- ClinicalTrials.gov ID
- NCT05093985
- Acronym / sponsor ID
- SMU-BFRImmob
- Conditions
- Atrophy, Muscular, Atrophy, Disuse
- Keywords
- immobilisation, blood flow restriction, neuromuscular electrical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- St Mary's University CollegeUniversity, hospital or other
- Study start
- 15 Nov 2021 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular electrical stimulation with blood flow restriction | Experimental | Other: Neuromuscular electrical stimulation with blood flow restrictionThis is the intervention condition |
| No intervention | No intervention | –This is the control condition |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulation with blood flow restrictionNeuromuscular electrical stimulation with blood flow restriction | Other | Neuromuscular electrical stimulation with blood flow restriction |
Primary outcome
Change in maximal isometric strength via Biodex Dynamometer
Time frame: Through study completion, an average of 1 year
Strength measure
Change in maximal isokinetic strength via Biodex Dynamometer
Time frame: Through study completion, an average of 1 year
Strength measure
6 secondary outcomes
Change in muscle endurance via Biodex Dynamometer
Time frame: Through study completion, an average of 1 year
Change in muscle morphology via 2D and 3D ultrasonography
Time frame: Through study completion, an average of 1 year
Change in muscle VO2 via near-infrared spectroscopy
Time frame: Through study completion, an average of 1 year
Change in blood markers via venous blood samples
Time frame: Through study completion, an average of 1 year
Change in pressure pain thresholds via handheld allometry
Time frame: Through study completion, an average of 1 year
Change in corticomotor excitability and inhibition, via transcranial magnetic stimulation
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Patterson, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation with blood flow restriction in people with Atrophy, Muscular and Atrophy, Disuse, run by St Mary's University College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luke Hughes, PhD (0208 240 4058 ext. 4058, Luke.hughes@stmarys.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximal isometric strength via Biodex Dynamometer (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021; AzTrials last refreshed its copy on 29 Oct 2026.