- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05586451
Muscle Activation With Acute Bouts of Blood Flow Restricted Resistance Exercise
September 10, 2023 updated by: Brian Irving, Louisiana State University and A&M College
Muscle Activation With Acute Bouts of Blood Flow Restricted Resistance Exercise Compared to High Load Resistance Exercise in Trained Versus Untrained Adults
Blood flow restricted (BFR) resistance exercise has been shown to improve skeletal muscle adaptations to low load resistance exercise.
One of many adaptations with resistance training is neural adaptations that occur within the first few weeks of resistance training.
It has been hypothesized that these neural adaptations are blunted when using blood flow restricted exercise.
Therefore, the investigators propose to examine the muscle activation created by resistance exercise with different intensities with blood flow restriction and without blood flow restriction in sedentary compared to resistance-trained individuals.
The investigators will recruit and completely study up to 30, previously untrained and resistance-trained, healthy, college-aged (18-40 years) males.
Participants will come in the laboratory for 5 total visits.
These visits will consist of a screening/familiarization visit, a strength testing visit, and 3 acute exercise visits.
The acute exercise visits will consist of 2 blood flow restricted resistance sessions at different intensities and a traditional high load resistance exercise session.
The 3 acute exercise visits will be randomized.
The investigators will measure muscle mass (appendicular lean mass) using Dual Energy X-Ray Absorptiometry, muscle strength and endurance using isotonic and isokinetic testing, and muscle activation using surface electromyography.
The investigators will also use near infrared spectroscopy (NIRS) to measure the muscle tissue (oxygen) saturation index (TSI) in the vastus lateralis during exercise.
Finally, the investigators will also draw blood before and after each exercise session to measure hormones, metabolites, and markers of inflammation using commercially available assays (e.g., ELISAs).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Brian A Irving
- Phone Number: 2255787179
- Email: brianairving@lsu.edu
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70803
- Lousiana State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Capable and willing to give written informed consent
- Capable of understanding inclusion and exclusion criteria
- 18-40 years of age
- A waist circumference < 40 inches.
- No medical condition that would limit their participation in supervised exercise sessions based on the Physical Activity Readiness Questionnaire for Everyone (PARQ+)
- No current prescription medications
- Willing to allow researchers to use data and images (e.g., Dual Energy X-Ray Absorptiometry) for research purposes after study participation is completed
- Either untrained or resistance-trained by the following definitions: Untrained individuals are considered those that report less than two days per week of structured (> 30 minutes) moderate to vigorous-intensity aerobic exercise and less than two days per week of structured resistance training for the 3 months prior to study start. Resistance-trained individuals are considered those who report performing structured moderate to intense resistance exercise for at least three days per week for at least 2 years prior to study start.
Exclusion Criteria:
- Self-report history of diabetes mellitus
- Self-report history of cardiovascular, peripheral vascular, cerebral vascular, pulmonary, or renal disease
- Self-report or evidence of uncontrolled hypertension > 150/85 (or measured)
- Self-report history of blood clotting disorders
- Self-report history of deep vein thrombosis or pulmonary embolism
- Self-report history of sickle cell trait
- Self-report history of varicose veins
- Self-report history of a myopathy leading to muscle loss, weakness, severe cramps or myalgia
- Self-report history of orthopedic limitations that would preclude them from participation in a dynamic exercise program
- Self-report history of musculoskeletal disorders (e.g., severe osteoarthritis, rheumatoid arthritis, avascular necrosis or osteonecrosis)
- Self-report history of neurological disorders (e.g., peripheral neuropathy, amyotrophic lateral sclerosis, multiple sclerosis, fibromyalgia, Parkinson's disease)
- Weight loss of > 10% in the last 3 months prior to screening
- Active tobacco use including smoking, vaping, or smokeless tobacco use
- Current consumption of > 14 alcoholic drinks per week based on self-report
- Any other condition that, in the judgement of the Principal Investigator and/or the Medical Director of this protocol, may interfere with study participation and adherence to the protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Resistance Trained
Resistance-trained individuals are considered those who report performing structured moderate to intense resistance exercise for at least three days per week for at least 2 years prior to study start.
|
Participants will then perform 75% of tested 1RM for 3 sets of 12 repetitions at a pace of 1 repetition every 2 seconds on the dominant leg with one-minute rest between sets.
After completing the HLRE protocol, participants will perform 2 post-exercise maximal voluntary contractions.
Participants will then perform 25% of tested 1RM for sets of 30, 15, 15, and 15 repetitions on the dominant leg at a pace of 1 repetition every 2 seconds with one-minute rest between sets.
Participants will be fitted with an occlusion cuff on the proximal portion of the thigh.
The limb occlusion pressure will be set at 60% blood flow occlusion and remain occluded throughout the exercise (Delfi Medical Innovations Personal Tourniquet System).
Participants will then perform 50% of tested 1RM for sets of 15, 8, 7, and 7 repetitions on the dominant leg at a pace of 1 repetition every 2 seconds with one-minute rest between sets.
Participants will be fitted with an occlusion cuff on the proximal portion of the thigh.
The limb occlusion pressure will be set at 60% blood flow occlusion and remain occluded throughout the exercise (Delfi Medical Innovations Personal Tourniquet System).
|
Other: Untrained
Untrained individuals are considered those that report less than two days per week of structured (> 30 minutes) moderate to vigorous-intensity aerobic exercise and less than two days per week of structured resistance training for the 3 months prior to study start.
|
Participants will then perform 75% of tested 1RM for 3 sets of 12 repetitions at a pace of 1 repetition every 2 seconds on the dominant leg with one-minute rest between sets.
After completing the HLRE protocol, participants will perform 2 post-exercise maximal voluntary contractions.
Participants will then perform 25% of tested 1RM for sets of 30, 15, 15, and 15 repetitions on the dominant leg at a pace of 1 repetition every 2 seconds with one-minute rest between sets.
Participants will be fitted with an occlusion cuff on the proximal portion of the thigh.
The limb occlusion pressure will be set at 60% blood flow occlusion and remain occluded throughout the exercise (Delfi Medical Innovations Personal Tourniquet System).
Participants will then perform 50% of tested 1RM for sets of 15, 8, 7, and 7 repetitions on the dominant leg at a pace of 1 repetition every 2 seconds with one-minute rest between sets.
Participants will be fitted with an occlusion cuff on the proximal portion of the thigh.
The limb occlusion pressure will be set at 60% blood flow occlusion and remain occluded throughout the exercise (Delfi Medical Innovations Personal Tourniquet System).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Activation Measured During Traditional High Load Resistance Exercise (HLRE)
Time Frame: Measurement will occur during the acute bout HLRE, which will occur during the HLRE study visit.
|
Muscle (vastus lateralis) activation will be measured using surface EMG, during the knee extension exercises conducted during the acute HLRE bout.
|
Measurement will occur during the acute bout HLRE, which will occur during the HLRE study visit.
|
Low Load Resistance Exercise with Blood Flow Restriction (LLBFR)
Time Frame: Measurement will occur during the acute bout LLBFR, which will occur during the LLBFR study visit.
|
Muscle (vastus lateralis) activation will be measured using surface EMG, during the knee extension exercises conducted during the acute LLBFR bout.
|
Measurement will occur during the acute bout LLBFR, which will occur during the LLBFR study visit.
|
Moderate Load Resistance Exercise with Blood Flow Restriction (MLBFR)
Time Frame: Measurement will occur during the acute bout MLBFR, which will occur during the MLBFR study visit.
|
Muscle activation (vastus lateralis) will be measured using surface EMG, during the knee extension exercises conducted during the acute MLBFR bout.
|
Measurement will occur during the acute bout MLBFR, which will occur during the MLBFR study visit.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Maximal Voluntary Contraction following HLRE
Time Frame: Measurements will be conducted before and immediately following the completion of the HLRE bout.
|
Maximal Voluntary (isometric) Contractions will be measured using an isokinetic dynamometer before and after the acute HLRE session.
|
Measurements will be conducted before and immediately following the completion of the HLRE bout.
|
Change in Maximal Voluntary Contraction following LLBFR
Time Frame: Measurements will be conducted before and immediately following the completion of the LLBFR bout.
|
Maximal Voluntary (isometric) Contractions will be measured using an isokinetic dynamometer before and after the acute LLBFR session.
|
Measurements will be conducted before and immediately following the completion of the LLBFR bout.
|
Change in Maximal Voluntary Contraction following MLBFR
Time Frame: Measurements will be conducted before and immediately following the completion of the MLBFR bout.
|
Maximal Voluntary (isometric) Contractions will be measured using an isokinetic dynamometer before and after the acute MLBFR session.
|
Measurements will be conducted before and immediately following the completion of the MLBFR bout.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Brian A Irving, School of Kinesiology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 5, 2022
Primary Completion (Actual)
August 1, 2023
Study Completion (Actual)
August 1, 2023
Study Registration Dates
First Submitted
August 1, 2022
First Submitted That Met QC Criteria
October 17, 2022
First Posted (Actual)
October 19, 2022
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 10, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- IRBAM-22-0600
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Available upon request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Muscle
-
United States Army Research Institute of Environmental...US Army Natick Soldier Research, Development & Engineering CenterCompletedMuscle Loss | Muscle Anabolism | Muscle PerformanceUnited States
-
University Hospital, Strasbourg, FranceTerminated
-
United States Army Research Institute of Environmental...Tufts UniversityCompletedMuscle Loss | Muscle AnabolismUnited States
-
Christian Müller, MDUniversity Hospital Inselspital, Berne; Medical University Innsbruck; University... and other collaboratorsRecruitingMuscle Weakness | Muscle Atrophy | Muscle Spasticity | Muscle Cramp | Muscle Soreness | Muscle Damage | Myopathy | Muscle InjurySwitzerland, Austria
-
Çağtay MadenCompletedForward Head Posture | Muscle Tone | Muscle Stiffnes | Muscle Elasticty | Vital CapacityTurkey
-
Koç UniversityCompletedMuscle Strength | Posture | Abdominal MuscleTurkey
-
University of Texas Southwestern Medical CenterAbhimanyu Garg; Prishant Mishra; Jimin RenCompletedMuscle Weakness | Muscle Cramp | Muscle Stiffness | Statin-related Muscle Pain | Muscle AchesUnited States
-
University of LiegeRecruitingMuscle Strength | Shoulder | Electromyography | Muscle ActivationBelgium
-
Ankara Yildirim Beyazıt UniversityCompletedShoulder | Muscle Architecture | Isokinetic | Rotator MuscleTurkey
-
Neuromed IRCCSRecruitingSpasticity, Muscle | Muscle Tone Abnormalities | Rigidity, MuscleItaly
Clinical Trials on Traditional High Load Resistance Exercise (HLRE)
-
National Taiwan Normal UniversityCompleted
-
University of GlasgowCompleted
-
Louisiana State University and A&M CollegeDelfi, Inc.Completed
-
Arizona State UniversityTerminatedBlood Pressure | Endothelial Dysfunction | Insulin SensitivityUnited States
-
VA Office of Research and DevelopmentRecruiting
-
University of AarhusHorsens Hospital; Regionshospitalet SilkeborgEnrolling by invitationLate-initiated Blood Flow Restricted Rehabilitation Exercises After Total Knee Replacement (EXKnee2)Osteoarthritis, Knee | Arthropathy of KneeDenmark
-
Federal University of VicosaCompletedDepression | Executive Function | Physical Functional PerformanceBrazil
-
University of PadovaUniversity of Roma La SapienzaCompletedExercise | Resistance TrainingItaly
-
Universidade Federal do vale do São FranciscoCompletedPost-Exercise Hypotension
-
Pusan National University Yangsan HospitalCompletedObesity | OverweightKorea, Republic of