- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07654608
Electromyographic Response to Blood Flow Restriction Exercise in Healthy Adults
Electromyographic Analysis of Immediate Neuromuscular Response After Low-Load Knee Extension Exercise With and Without Blood Flow Restriction in Healthy Adults
This pilot randomized contralateral within-participant study evaluated the immediate neuromuscular response to low-load knee extension exercise performed with and without blood flow restriction in healthy young adults.
Participants were randomized in a 1:1 ratio to one of two limb-allocation groups: blood flow restriction applied to the dominant limb or blood flow restriction applied to the non-dominant limb. In each participant, the contralateral limb completed the same exercise protocol without blood flow restriction. Therefore, all participants were assessed under both experimental conditions.
Both limb-specific conditions were completed during the same experimental session. The order of the blood flow restriction and non-blood flow restriction conditions was randomized for each participant, with a 10-minute rest period between conditions.
Blood flow restriction was applied using a pneumatic cuff positioned on the proximal thigh. Cuff pressure was individualized and set at 80% of the arterial occlusion pressure measured for the corresponding limb. Participants completed the same standardized low-load knee extension protocol under both conditions.
Surface electromyography was used to record vastus lateralis activity from each assessed limb during the exercise protocol. Muscle activity was primarily evaluated using root mean square amplitude normalized to the pre-exercise maximal voluntary isometric contraction recorded from the corresponding limb. Root mean square amplitude during maximal voluntary isometric contraction trials was also recorded before and immediately after each condition.
The study aimed to compare the electromyographic response between the blood flow restriction and non-blood flow restriction conditions and to determine whether this response differed according to whether blood flow restriction was applied to the dominant or non-dominant limb.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Badajoz
-
Badajoz, Badajoz, Spain, 06006
- University of Extremadura
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 65 years.
- Healthy adults.
- Absence of active pain or musculoskeletal injury in the lower limbs at the time of assessment.
- Ability to understand the study procedures.
- Voluntary agreement to participate and provision of written informed consent.
Exclusion Criteria:
- History of neuromuscular disease.
- History of cardiovascular disease.
- History of peripheral vascular disease.
- History of thromboembolic events.
- Uncontrolled hypertension.
- Skin lesions or skin conditions preventing placement of the blood flow restriction cuff or surface electromyography electrodes.
- Recent lower limb surgery.
- Pregnancy.
- Any other contraindication to blood flow restriction exercise.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: BFR allocated to the dominant limb
Participants received blood flow restriction on the dominant limb, while the contralateral non-dominant limb completed the same low-load knee extension protocol without blood flow restriction.
Both limb-specific conditions were performed during the same experimental session in randomized order, with a 10-minute rest period between conditions.
Blood flow restriction pressure was individualized and set at 80% of the arterial occlusion pressure of the corresponding limb.
Vastus lateralis surface electromyography was recorded under both conditions.
|
Each participant completed the low-load knee extension exercise protocol separately with both lower limbs.
Under each condition, the protocol comprised 75 repetitions distributed across four sets of 30, 15, 15, and 15 repetitions, with 30 seconds of rest between sets.
One limb performed the protocol with blood flow restriction and the contralateral limb performed it without blood flow restriction.
Condition order was randomized, and a 10-minute rest period was provided between the two limb-specific conditions.
Vastus lateralis surface electromyography was recorded continuously during each protocol.
A pneumatic cuff was placed on the proximal thigh of the limb randomized to the blood flow restriction condition and inflated to 80% of the individualized arterial occlusion pressure during the low-load knee extension protocol.
The cuff was not applied to the contralateral limb, which completed the same protocol under the non-blood flow restriction condition.
The cuff was fully deflated and removed after completion of the blood flow restriction condition.
|
|
Experimental: Experimental: BFR allocated to the non-dominant limb
Participants received blood flow restriction on the non-dominant limb, while the contralateral dominant limb completed the same low-load knee extension protocol without blood flow restriction.
Both limb-specific conditions were performed during the same experimental session in randomized order, with a 10-minute rest period between conditions.
Blood flow restriction pressure was individualized and set at 80% of the arterial occlusion pressure of the corresponding limb.
Vastus lateralis surface electromyography was recorded under both conditions.
|
Each participant completed the low-load knee extension exercise protocol separately with both lower limbs.
Under each condition, the protocol comprised 75 repetitions distributed across four sets of 30, 15, 15, and 15 repetitions, with 30 seconds of rest between sets.
One limb performed the protocol with blood flow restriction and the contralateral limb performed it without blood flow restriction.
Condition order was randomized, and a 10-minute rest period was provided between the two limb-specific conditions.
Vastus lateralis surface electromyography was recorded continuously during each protocol.
A pneumatic cuff was placed on the proximal thigh of the limb randomized to the blood flow restriction condition and inflated to 80% of the individualized arterial occlusion pressure during the low-load knee extension protocol.
The cuff was not applied to the contralateral limb, which completed the same protocol under the non-blood flow restriction condition.
The cuff was fully deflated and removed after completion of the blood flow restriction condition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vastus Lateralis Electromyographic Amplitude Normalized to Maximal Voluntary Isometric Contraction
Time Frame: During the exercise protocol, within a single experimental session.
|
Surface electromyographic activity of the vastus lateralis was assessed during the low-load knee extension exercise protocol.
The root mean square amplitude was normalized to the maximal voluntary isometric contraction recorded before exercise and expressed as percentage of maximal voluntary isometric contraction (%MVIC).
Measurements were extracted at predefined time points across the four exercise sets in both experimental conditions.
|
During the exercise protocol, within a single experimental session.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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