Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05093985
Other study ID # SMU-BFRImmob
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 15, 2021
Est. completion date October 1, 2023

Study information

Verified date October 2021
Source St Mary's University College
Contact Luke Hughes, PhD
Phone 0208 240 4058
Email Luke.hughes@stmarys.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date October 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Intervention

Other:
Neuromuscular electrical stimulation with blood flow restriction
Neuromuscular electrical stimulation with blood flow restriction

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
St Mary's University College

Outcome

Type Measure Description Time frame Safety issue
Primary Change in maximal isometric strength via Biodex Dynamometer Strength measure Through study completion, an average of 1 year
Primary Change in maximal isokinetic strength via Biodex Dynamometer Strength measure Through study completion, an average of 1 year
Secondary Change in muscle endurance via Biodex Dynamometer Endurance measure Through study completion, an average of 1 year
Secondary Change in muscle morphology via 2D and 3D ultrasonography Morphology measure Through study completion, an average of 1 year
Secondary Change in muscle VO2 via near-infrared spectroscopy VO2 measure Through study completion, an average of 1 year
Secondary Change in blood markers via venous blood samples Blood markers Through study completion, an average of 1 year
Secondary Change in pressure pain thresholds via handheld allometry Pain measure Through study completion, an average of 1 year
Secondary Change in corticomotor excitability and inhibition, via transcranial magnetic stimulation Corticospinal function Through study completion, an average of 1 year
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05670080 - Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair? N/A
Recruiting NCT04436523 - Blood Flow Restriction After Meniscus Repair N/A
Completed NCT00964340 - A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral SRT2104 Capsules Administered to Healthy Elderly Subjects for 28 Days Phase 1
Not yet recruiting NCT04861857 - Effects of Parmigiano Reggiano on Muscle and Inflammatory Response to Eccentric Resistance Training in Older Adults N/A
Recruiting NCT05776862 - Study Testing Benefits of Ursolic Acid (UA) as a Countermeasure To Myopenia and Insulin Resistance in Chronic Spinal Cord Injury (SCI) Phase 2
Withdrawn NCT01039909 - A Clinical Study to Assess the Effects of SRT2104 Upon Immobilization-Induced Skeletal Muscle Atrophy in Healthy Human Volunteers Phase 1
Completed NCT05773469 - Energy Balance in Extreme Environments: Finding the EI Limit
Withdrawn NCT06032247 - Bilateral Versus Unilateral Strength Training After ACLR N/A
Recruiting NCT05008705 - Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly N/A
Not yet recruiting NCT05760066 - Effects of Resistance Training Preconditioning on Skeletal Muscle Recovery From a Period of Disuse in Young Adults N/A
Completed NCT01476072 - 31P MRS Ischaemic Exercise Optimisation and COPD Phase 1