- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03723226
BFR and Muscle Mitochondrial Oxidative Capacity
August 14, 2023 updated by: Brian Irving, Louisiana State University and A&M College
Impact of Low-Intensity Resistance Exercise With and Without Blood Flow Redistricted (BFR) on 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70803
- Lousiana State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)
|
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
|
Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)
|
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
|
Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Brian Irving, PhD, Louisiana State University - Kinesiology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 28, 2019
Primary Completion (Actual)
July 1, 2023
Study Completion (Actual)
July 1, 2023
Study Registration Dates
First Submitted
September 21, 2018
First Submitted That Met QC Criteria
October 25, 2018
First Posted (Actual)
October 29, 2018
Study Record Updates
Last Update Posted (Actual)
August 16, 2023
Last Update Submitted That Met QC Criteria
August 14, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#3934
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertrophy
-
Rhode Island HospitalCompletedChildren, Only | Tonsillar Hypertrophy | Adenoid HypertrophyUnited States
-
Olubukola NafiuNot yet recruitingSurgery | Tonsillar Hypertrophy | Adenoid Hypertrophy
-
Nagoya UniversityUnknownHypertensive Left Ventricular HypertrophyJapan
-
Istanbul UniversityWithdrawn
-
Organon and CoCompleted
-
Seoul National University HospitalSamsung Medical Center; Chung-Ang University Hosptial, Chung-Ang University... and other collaboratorsCompletedTonsillar HypertrophyKorea, Republic of
-
Marymount UniversityUniversity of TehranCompleted
-
Mansoura UniversityCompleted
-
Marmara UniversityCompletedFrenulum; Hypertrophy, Lip
-
Assistance Publique - Hôpitaux de ParisInstitute of Cardiometabolism and Nutrition, FranceNot yet recruitingLeft Ventricular HypertrophyFrance
Clinical Trials on Low Load Resistance Exercise
-
National Taiwan Normal UniversityCompleted
-
University of GlasgowCompleted
-
Louisiana State University and A&M CollegeCompletedMuscle | Acute ExerciseUnited States
-
University of AarhusHorsens Hospital; Regionshospitalet SilkeborgEnrolling by invitationLate-initiated Blood Flow Restricted Rehabilitation Exercises After Total Knee Replacement (EXKnee2)Osteoarthritis, Knee | Arthropathy of KneeDenmark
-
Defence Medical Rehabilitation Centre, UKUniversity of BathRecruitingMuscle Weakness | Muscle DamageUnited Kingdom
-
Arizona State UniversityTerminatedBlood Pressure | Endothelial Dysfunction | Insulin SensitivityUnited States
-
AspetarRecruitingPatellofemoral Pain Syndrome | Knee Pain Chronic | Rotator Cuff Tendinosis | Rotator Cuff Impingement Syndrome | Anterior Knee Pain SyndromeQatar
-
VA Office of Research and DevelopmentRecruiting
-
University of Colorado, DenverDavis Phinney FoundationRecruitingLow-load Resistance Training With Blood Flow Restriction in People With Parkinson's Disease (BFR-PD)Parkinson DiseaseUnited States
-
European University CyprusNot yet recruitingShoulder Pain | Shoulder Impingement | BFRCyprus