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CompletedNCT03723226Updated Aug 16, 2023

BFR and Muscle Mitochondrial Oxidative Capacity

An interventional study of Low Load Resistance Exercise and Low Load Resistance Exercise + BFR in Mitochondria, Strength and Hypertrophy, sponsored by Louisiana State University and A&M College. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-16.

Sponsored by Louisiana State University and A&M College · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Mitochondria
  • Strength
  • Hypertrophy

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03

In context

Hypertrophy

656 studies on the registry are indexed under Hypertrophy; 87 are open to participants now.

This study's enrollment of 24 is below the median of 50 across 460 interventional studies indexed under Hypertrophy.

Browse Hypertrophy studies →

Lead sponsor

Louisiana State University and A&M College is the lead sponsor of 13 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    Low Load Resistance Exercise

    Subjects allocated to Low Load Resistance Exercise will undergo 6 weeks of single-legged low load (25%) resistance exercise. Their contralateral leg will serve as within subject control.

    Behavioral: Low Load Resistance Exercise

  • Experimental
    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 plus blood flow restriction. Their contralateral leg will serve as within subject control.

    Behavioral: Low Load Resistance Exercise + BFR

Interventions

  • BehavioralLow 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.

  • BehavioralLow 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.

06

What researchers measure

Primary outcomes

  1. Changes in Mitochondrial Oxidative Capacity

    Changes in mitochondrial oxidative capacity will be measured using near infrared spectroscopy (NIRS).

    Time frame: Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training).

Secondary outcomes

  1. Changes in Muscle Mass measured by Dual Energy X-ray Absorptiometry

    Changes in muscle mass will be measured by Dual Energy X-ray Absorptiometry

    Time frame: Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)

  2. Changes in Muscle Strength measured using Isokinetic Dynamometry

    Changes in muscle strength measured using isokinetic dynamometry

    Time frame: Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)

  3. Changes in Muscle Endurance measured using Isokinetic Dynamometry

    Changes in muscle endurance measured using isokinetic dynamometry

    Time frame: Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)

07

Study locations

1 site
  • Lousiana State University
    Baton Rouge, Louisiana 70803, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03723226
Lead sponsor
Louisiana State University and A&M College
Collaborators
Delfi, Inc.
Responsible party
Brian Irving (Assistant Professor, Louisiana State University and A&M College) — Principal investigator
First posted
Oct 29, 2018
Start date
Jan 28, 2019
Primary completion
Jul 1, 2023
Completion
Jul 1, 2023
Last update
Aug 16, 2023

Study contacts

Brian Irving, PhD
principal investigator · Louisiana State University - Kinesiology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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