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Completed

NCT Number: NCT03723226

BFR and Muscle Mitochondrial Oxidative Capacity

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lousiana State University

Baton Rouge, Louisiana, 70803, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

.

  • Capable and willing to give written informed consent
  • Capable of understanding inclusion and exclusion criteria
  • 18-40 years of age inclusive
  • Body Mass Index (BMI) between 18.5-30 kg/m2 inclusive
  • No medical condition that would limit their participation in supervised exercise training based on the Physical Activity Readiness Questionnaire for Everyone (PARQ+)
  • No current prescription medications, with the exception of birth control
  • 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

.

  • Evidence or self-report being pregnant, lactating, or anticipating becoming pregnant in the next year
  • Participation in resistance or aerobic exercise training > 2 days per week within the 3 months prior to screening
  • Self-report of history of type 1 or 2 diabetes mellitus
  • Self-report history of cardiovascular, peripheral vascular, cerebral vascular, pulmonary, or renal disease
  • Self-report or evidence of uncontrolled hypertension
  • 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 smoking
  • Current consumption of > 14 alcoholic drinks per week based on self-report
  • Absolute Contraindication to Exercise as Defined by the American College of Sports Medicine,1 including:
  • Resting diastolic blood pressure > 100 mm Hg
  • Resting systolic blood pressure > 180 mm Hg
  • Resting heart rate > 100 beats per min
  • Self-report acute viral or bacterial upper or lower respiratory infection at screening
  • 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

Treatment and study plan

Low Load Resistance Exercise

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Changes in Mitochondrial Oxidative Capacity

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

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

Secondary outcomes

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

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

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

  2. Changes in Muscle Strength measured using Isokinetic Dynamometry

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

    Changes in muscle strength measured using isokinetic dynamometry

  3. Changes in Muscle Endurance measured using Isokinetic Dynamometry

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

    Changes in muscle endurance measured using isokinetic dynamometry

Sponsors and collaborators

Lead sponsor

Louisiana State University and A&M College

Other

Collaborators

  • Delfi, Inc.

Registry information

Official study title

Impact of Low-Intensity Resistance Exercise With and Without Blood Flow Redistricted (BFR) on Muscle Mitochondrial Oxidative Capacity

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 29, 2018
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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