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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03723226
Other study ID # IRB#3934
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 28, 2019
Est. completion date July 1, 2023

Study information

Verified date August 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) exercise has been shown to improve skeletal muscle adaptations to resistance exercise. BFR uses blood pressure cuffs (i.e., tourniquets) to reduce skeletal muscle blood flow during resistance exercise. One benefit of BFR is that skeletal muscle adaptations to resistance exercise training including muscle hypertrophy and increases in strength can be achieved at lower-loads (e.g., 25-30% 1RM), that are often comparable to more traditional resistance training loads (70-85% 1RM). However, the impact that low-load BFR resistance exercise has on muscle quality and bioenergetics is unknown. The present study will examine the impact of 6 weeks of low-load, single-leg resistance exercise training with or without personalized BFR on measures of muscle mass, strength, quality, and mitochondrial bioenergetics. The investigators will recruit and study up to 30, previously sedentary, healthy, college-aged adults (18-40 years). The investigators will measure muscle mass using Dual Energy X-Ray Absorptiometry and muscle strength and endurance using isokinetic testing. The investigators will normalize knee extensor strength to lower limb lean mass to quantify muscle quality. The investigators will also use near infrared spectroscopy (NIRS) to measure mitochondrial oxidative capacity in the vastus lateralis. Finally, the investigators will measure markers of systemic inflammation and markers of muscle damage using commercially available ELISA assays.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date July 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
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 inclusive 4. Body Mass Index (BMI) between 18.5-30 kg/m2 inclusive 5. No medical condition that would limit their participation in supervised exercise training based on the Physical Activity Readiness Questionnaire for Everyone (PARQ+) 6. No current prescription medications, with the exception of birth control 7. Willing to allow researchers to use data, biospecimens (e.g., blood) and images (e.g., Dual Energy x-Ray Absorptiometry) for research purposes after study participation is completed Exclusion Criteria. 1. Evidence or self-report being pregnant, lactating, or anticipating becoming pregnant in the next year 2. Participation in resistance or aerobic exercise training > 2 days per week within the 3 months prior to screening 3. Self-report of history of type 1 or 2 diabetes mellitus 4. Self-report history of cardiovascular, peripheral vascular, cerebral vascular, pulmonary, or renal disease 5. Self-report or evidence of uncontrolled hypertension 6. Self-report history of blood clotting disorders 7. Self-report history of deep vein thrombosis or pulmonary embolism 8. Self-report history of sickle cell trait 9. Self-report history of varicose veins 10. Self-report history of a myopathy leading to muscle loss, weakness, severe cramps or myalgia 11. Self-report history of orthopedic limitations that would preclude them from participation in a dynamic exercise program 12. Self-report history of musculoskeletal disorders (e.g., severe osteoarthritis, rheumatoid arthritis, avascular necrosis or osteonecrosis) 13. Self-report history of neurological disorders (e.g., peripheral neuropathy, amyotrophic lateral sclerosis, multiple sclerosis, fibromyalgia, Parkinson's disease) 14. Weight loss of > 10% in the last 3 months prior to screening 15. Active smoking 16. Current consumption of > 14 alcoholic drinks per week based on self-report 17. Absolute Contraindication to Exercise as Defined by the American College of Sports Medicine,1 including: 1. Resting diastolic blood pressure > 100 mm Hg 2. Resting systolic blood pressure > 180 mm Hg 3. Resting heart rate > 100 beats per min 18. Self-report acute viral or bacterial upper or lower respiratory infection at screening 19. 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:
Low Load Resistance Exercise
Subjects allocated to Low Load Resistance Exercise will undergo 6 weeks of single-legged low load (25%) resistance exercise. Subjects will then perform 4 sets of 30, 15, 15 and 15 repetitions at 25% of their 1RM for the single-legged leg press and single-legged knee extensions. Their contralateral leg will serve as within subject control.
Low Load Resistance Exercise + BFR
Subjects allocated to Low Load Resistance Exercise + BFR will undergo 6 weeks of single-legged low load (25%) resistance exercise with blood flow restriction (60% occlusion pressure). Subjects will then perform 4 sets of 30, 15, 15 and 15 repetitions at 25% of their 1RM for the single-legged leg press and single-legged knee extensions. Their contralateral leg will serve as within subject control.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Louisiana State University and A&M College Delfi, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Mitochondrial Oxidative Capacity Changes in mitochondrial oxidative capacity will be measured using near infrared spectroscopy (NIRS). Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training).
Secondary Changes in Muscle Mass measured by Dual Energy X-ray Absorptiometry Changes in muscle mass will be measured by Dual Energy X-ray Absorptiometry Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)
Secondary Changes in Muscle Strength measured using Isokinetic Dynamometry Changes in muscle strength measured using isokinetic dynamometry Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)
Secondary Changes in Muscle Endurance measured using Isokinetic Dynamometry Changes in muscle endurance measured using isokinetic dynamometry Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)
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