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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05586451
Other study ID # IRBAM-22-0600
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 5, 2022
Est. completion date August 1, 2023

Study information

Verified date September 2023
Source Louisiana State University and A&M College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: 1. Capable and willing to give written informed consent 2. Capable of understanding inclusion and exclusion criteria 3. 18-40 years of age 4. A waist circumference < 40 inches. 5. No medical condition that would limit their participation in supervised exercise sessions based on the Physical Activity Readiness Questionnaire for Everyone (PARQ+) 6. No current prescription medications 7. Willing to allow researchers to use data and images (e.g., Dual Energy X-Ray Absorptiometry) for research purposes after study participation is completed 8. 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: 1. Self-report history of diabetes mellitus 2. Self-report history of cardiovascular, peripheral vascular, cerebral vascular, pulmonary, or renal disease 3. Self-report or evidence of uncontrolled hypertension > 150/85 (or measured) 4. Self-report history of blood clotting disorders 5. Self-report history of deep vein thrombosis or pulmonary embolism 6. Self-report history of sickle cell trait 7. Self-report history of varicose veins 8. Self-report history of a myopathy leading to muscle loss, weakness, severe cramps or myalgia 9. Self-report history of orthopedic limitations that would preclude them from participation in a dynamic exercise program 10. Self-report history of musculoskeletal disorders (e.g., severe osteoarthritis, rheumatoid arthritis, avascular necrosis or osteonecrosis) 11. Self-report history of neurological disorders (e.g., peripheral neuropathy, amyotrophic lateral sclerosis, multiple sclerosis, fibromyalgia, Parkinson's disease) 12. Weight loss of > 10% in the last 3 months prior to screening 13. Active tobacco use including smoking, vaping, or smokeless tobacco use 14. Current consumption of > 14 alcoholic drinks per week based on self-report 15. 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
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).
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).

Locations

Country Name City State
United States Lousiana State University Baton Rouge Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Louisiana State University and A&M College

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Measurement will occur during the acute bout HLRE, which will occur during the HLRE study visit.
Primary 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. Measurement will occur during the acute bout LLBFR, which will occur during the LLBFR study visit.
Primary 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. Measurement will occur during the acute bout MLBFR, which will occur during the MLBFR study visit.
Secondary 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. Measurements will be conducted before and immediately following the completion of the HLRE bout.
Secondary 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. Measurements will be conducted before and immediately following the completion of the LLBFR bout.
Secondary 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. Measurements will be conducted before and immediately following the completion of the MLBFR bout.
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