MitochondriaNCT03723226
BFR and Muscle Mitochondrial Oxidative Capacity
A study testing Low Load Resistance Exercise and Low Load Resistance Exercise + BFR in people with Mitochondria and Strength, run by Louisiana State University and A&M College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Mitochondria, Strength, Hypertrophy
- What is being tested?
- Low Load Resistance Exercise and Low Load Resistance Exercise + BFR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2019to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lousiana State University
Baton Rouge, Louisiana, 70803
About this study
Official title: 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.
- Conditions
- Mitochondria, Strength, Hypertrophy
- Being tested
- Low Load Resistance Exercise, Low Load Resistance Exercise + BFR
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Load Resistance ExerciseBehavioural
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 + BFRBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Load Resistance Exercise | Active comparator | 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. Receives: Behavioral: Low Load Resistance Exercise |
| Low Load Resistance Exercise + BFR | Experimental | 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. Receives: Behavioral: Low Load Resistance Exercise + BFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Mitochondrial Oxidative Capacity
Changes in mitochondrial oxidative capacity will be measured using near infrared spectroscopy (NIRS).
Measured: Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training).
Secondary outcomes (3)
Changes in Muscle Mass measured by Dual Energy X-ray Absorptiometry
Changes in muscle mass will be measured by Dual Energy X-ray Absorptiometry
Measured: Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)
Changes in Muscle Strength measured using Isokinetic Dynamometry
Changes in muscle strength measured using isokinetic dynamometry
Measured: Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)
Changes in Muscle Endurance measured using Isokinetic Dynamometry
Changes in muscle endurance measured using isokinetic dynamometry
Measured: Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start28 Jan 2019
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MitochondriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University and A&M College
- Sponsor type
- University, hospital or other
- Collaborators
- Delfi, Inc.
- Responsible party
- Principal investigator, Brian Irving, Louisiana State University and A&M College
- Investigators
- Brian Irving, PhD, Principal investigator, Louisiana State University - Kinesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723226
- Sponsor's protocol ID
- IRB#3934
- Status last verified
- Aug 2023
- First submitted
- 21 Sep 2018
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Low-Intensity Resistance Exercise With and Without Blood Flow Redistricted (BFR) on Muscle Mitochondrial Oxidative Capacity
- ClinicalTrials.gov ID
- NCT03723226
- Acronym / sponsor ID
- IRB#3934
- Conditions
- Mitochondria, Strength, Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Louisiana State University and A&M CollegeUniversity, hospital or other
- Collaborators
- Delfi, Inc.
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Load Resistance Exercise | Active comparator | Behavioral: Low Load Resistance ExerciseSubjects 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. |
| Low Load Resistance Exercise + BFR | Experimental | Behavioral: Low Load Resistance Exercise + BFRSubjects 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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+)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Load Resistance ExerciseSubjects 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. | Behavioural | Low Load Resistance Exercise |
| Low Load Resistance Exercise + BFRSubjects 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. | Behavioural | Low Load Resistance Exercise + BFR |
Primary outcome
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).
3 secondary outcomes
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 Strength 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
Time frame: Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Irving, PhD principal investigator
Louisiana State University - Kinesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Load Resistance Exercise and Low Load Resistance Exercise + BFR in people with Mitochondria and Strength, run by Louisiana State University and A&M College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Mitochondrial Oxidative Capacity (time frame: Changes from baseline (pre-training) to follow-up (about 48-72 hours post-training).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.