BFR and Muscle Mitochondrial Oxidative Capacity

Sponsor
Louisiana State University and A&M College (Other)
Overall Status
Recruiting
CT.gov ID
NCT03723226
Collaborator
Delfi, Inc. (Other)
30
1
2
55.1
0.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Low Load Resistance Exercise
  • Behavioral: Low Load Resistance Exercise + BFR
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Impact of Low-Intensity Resistance Exercise With and Without Blood Flow Redistricted (BFR) on Muscle Mitochondrial Oxidative Capacity
Actual Study Start Date :
Jan 28, 2019
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.

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
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.

Outcome Measures

Primary Outcome Measures

  1. Changes in Mitochondrial Oxidative Capacity [Changes from baseline (pre-training) to follow-up (about 72 hours post-training).]

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

Secondary Outcome Measures

  1. Changes in Muscle Mass measured by Dual Energy X-ray Absorptiometry [Changes from baseline (pre-training) to follow-up (about 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 [Changes from baseline (pre-training) to follow-up (about 72 hours post-training)]

    Changes in muscle strength measured using isokinetic dynamometry

  3. Changes in Muscle Endurance measured using Isokinetic Dynamometry [Changes from baseline (pre-training) to follow-up (about 72 hours post-training)]

    Changes in muscle endurance measured using isokinetic dynamometry

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
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.

  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

  4. Self-report acute viral or bacterial upper or lower respiratory infection at screening

  5. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lousiana State University Baton Rouge Louisiana United States 70803

Sponsors and Collaborators

  • Louisiana State University and A&M College
  • Delfi, Inc.

Investigators

  • Principal Investigator: Brian Irving, PhD, Louisiana State University - Kinesiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brian Irving, Assistant Professor, Louisiana State University and A&M College
ClinicalTrials.gov Identifier:
NCT03723226
Other Study ID Numbers:
  • IRB#3934
First Posted:
Oct 29, 2018
Last Update Posted:
Aug 2, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022