MuscleNCT05586451
Muscle Activation With Acute Bouts of Blood Flow Restricted Resistance Exercise
A study testing Traditional High Load Resistance Exercise (HLRE), Low Load Resistance Exercise with Blood Flow Restriction (LLBFR) and Moderate Load Resistance Exercise with Blood Flow Restriction (MLBFR) in people with Muscle and Acute Exercise, run by Louisiana State University and A&M College at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle, Acute Exercise
- What is being tested?
- Traditional High Load Resistance Exercise (HLRE), Low Load Resistance Exercise with Blood Flow Restriction (LLBFR) and Moderate Load Resistance Exercise with Blood Flow Restriction (MLBFR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to 1 Aug 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lousiana State University
Baton Rouge, Louisiana, 70803
About this study
Official title: 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).
- Conditions
- Muscle, Acute Exercise
- Being tested
- Traditional High Load Resistance Exercise (HLRE), Low Load Resistance Exercise with Blood Flow Restriction (LLBFR), Moderate Load Resistance Exercise with Blood Flow Restriction (MLBFR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional High Load Resistance Exercise (HLRE)Behavioural
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.
Low Load Resistance Exercise with Blood Flow Restriction (LLBFR)Behavioural
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).
Moderate Load Resistance Exercise with Blood Flow Restriction (MLBFR)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Resistance Trained | Other | 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. Receives: Behavioral: Traditional High Load Resistance Exercise (HLRE); Behavioral: Low Load Resistance Exercise with Blood Flow Restriction (LLBFR); Behavioral: Moderate Load Resistance Exercise with Blood Flow Restriction (MLBFR) |
| Untrained | Other | 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. Receives: Behavioral: Traditional High Load Resistance Exercise (HLRE); Behavioral: Low Load Resistance Exercise with Blood Flow Restriction (LLBFR); Behavioral: Moderate Load Resistance Exercise with Blood Flow Restriction (MLBFR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Activation Measured During Traditional High Load Resistance Exercise (HLRE)
Muscle (vastus lateralis) activation will be measured using surface EMG, during the knee extension exercises conducted during the acute HLRE bout.
Measured: 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)
Muscle (vastus lateralis) activation will be measured using surface EMG, during the knee extension exercises conducted during the acute LLBFR bout.
Measured: 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)
Muscle activation (vastus lateralis) will be measured using surface EMG, during the knee extension exercises conducted during the acute MLBFR bout.
Measured: Measurement will occur during the acute bout MLBFR, which will occur during the MLBFR study visit.
Secondary outcomes (3)
Change in Maximal Voluntary Contraction following HLRE
Maximal Voluntary (isometric) Contractions will be measured using an isokinetic dynamometer before and after the acute HLRE session.
Measured: Measurements will be conducted before and immediately following the completion of the HLRE bout.
Change in Maximal Voluntary Contraction following LLBFR
Maximal Voluntary (isometric) Contractions will be measured using an isokinetic dynamometer before and after the acute LLBFR session.
Measured: Measurements will be conducted before and immediately following the completion of the LLBFR bout.
Change in Maximal Voluntary Contraction following MLBFR
Maximal Voluntary (isometric) Contractions will be measured using an isokinetic dynamometer before and after the acute MLBFR session.
Measured: Measurements will be conducted before and immediately following the completion of the MLBFR bout.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start5 Jul 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MuscleStudies 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University and A&M College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Irving, Louisiana State University and A&M College
- Investigators
- Brian A Irving, Principal investigator, School of Kinesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586451
- Sponsor's protocol ID
- IRBAM-22-0600
- Status last verified
- Sep 2023
- First submitted
- 1 Aug 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Activation With Acute Bouts of Blood Flow Restricted Resistance Exercise Compared to High Load Resistance Exercise in Trained Versus Untrained Adults
- ClinicalTrials.gov ID
- NCT05586451
- Acronym / sponsor ID
- IRBAM-22-0600
- Conditions
- Muscle, Acute Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Louisiana State University and A&M CollegeUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 19 Oct 2022 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Trained | Other | Behavioral: Traditional High Load Resistance Exercise (HLRE), Behavioral: Low Load Resistance Exercise with Blood Flow Restriction (LLBFR), Behavioral: Moderate Load Resistance Exercise with Blood Flow Restriction (MLBFR)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. |
| Untrained | Other | Behavioral: Traditional High Load Resistance Exercise (HLRE), Behavioral: Low Load Resistance Exercise with Blood Flow Restriction (LLBFR), Behavioral: Moderate Load Resistance Exercise with Blood Flow Restriction (MLBFR)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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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+)
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Traditional High Load Resistance Exercise (HLRE)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. | Behavioural | Resistance Trained, Untrained |
| Low Load Resistance Exercise with Blood Flow Restriction (LLBFR)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). | Behavioural | Resistance Trained, Untrained |
| Moderate Load Resistance Exercise with Blood Flow Restriction (MLBFR)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). | Behavioural | Resistance Trained, Untrained |
Primary outcome
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.
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.
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.
3 secondary outcomes
Change in Maximal Voluntary Contraction following HLRE
Time frame: 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.
Change in Maximal Voluntary Contraction following MLBFR
Time frame: Measurements will be conducted before and immediately following the completion of the MLBFR bout.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: Undecided. Available upon request.
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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.
Brian A Irving principal investigator
School of Kinesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional High Load Resistance Exercise (HLRE), Low Load Resistance Exercise with Blood Flow Restriction (LLBFR) and Moderate Load Resistance Exercise with Blood Flow Restriction (MLBFR) in people with Muscle and Acute Exercise, run by Louisiana State University and A&M College at 1 site in United States.
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 8 inclusion and 15 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: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 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 13 Sep 2023.