BFR and Muscle Mitochondrial Oxidative Capacity
Primary Purpose
Mitochondria, Strength, Hypertrophy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Load Resistance Exercise
Low Load Resistance Exercise + BFR
Sponsored by
About this trial
This is an interventional basic science trial for Mitochondria
Eligibility Criteria
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
Sites / Locations
- Lousiana State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Low Load Resistance Exercise
Low Load Resistance Exercise + BFR
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in Mitochondrial Oxidative Capacity
Changes in mitochondrial oxidative capacity will be measured using near infrared spectroscopy (NIRS).
Secondary Outcome Measures
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 in Muscle Strength measured using Isokinetic Dynamometry
Changes in muscle strength measured using isokinetic dynamometry
Changes in Muscle Endurance measured using Isokinetic Dynamometry
Changes in muscle endurance measured using isokinetic dynamometry
Full Information
NCT ID
NCT03723226
First Posted
September 21, 2018
Last Updated
August 14, 2023
Sponsor
Louisiana State University and A&M College
Collaborators
Delfi, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03723226
Brief Title
BFR and Muscle Mitochondrial Oxidative Capacity
Official Title
Impact of Low-Intensity Resistance Exercise With and Without Blood Flow Redistricted (BFR) on Muscle Mitochondrial Oxidative Capacity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 28, 2019 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louisiana State University and A&M College
Collaborators
Delfi, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitochondria, Strength, Hypertrophy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Load Resistance Exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Low Load Resistance Exercise + BFR
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low Load Resistance Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low Load Resistance Exercise + BFR
Intervention Description
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 Outcome Measure Information:
Title
Changes in Mitochondrial Oxidative Capacity
Description
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 Outcome Measure Information:
Title
Changes in Muscle Mass measured by Dual Energy X-ray Absorptiometry
Description
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)
Title
Changes in Muscle Strength measured using Isokinetic Dynamometry
Description
Changes in muscle strength measured using isokinetic dynamometry
Time Frame
Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)
Title
Changes in Muscle Endurance measured using Isokinetic Dynamometry
Description
Changes in muscle endurance measured using isokinetic dynamometry
Time Frame
Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Irving, PhD
Organizational Affiliation
Louisiana State University - Kinesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lousiana State University
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70803
Country
United States
12. IPD Sharing Statement
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BFR and Muscle Mitochondrial Oxidative Capacity
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