HealthyNCT03983070
The Effects of Lower Extremity Blood Flow Restriction Training on Power, and Muscle Size.
A study testing Seated Rowing Ergometer, Deadlift and Blood flow restriction in people with Healthy, run by Campbell University, Incorporated at 1 site in United States.
Trial summary
Blood-flow restriction training (BFR) is a technique utilized to provide the benefits of high intensity exercise (strength, power, hypertrophy) when applied to exercise intensities that are insufficient to produce these benefits without BFR. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Seated Rowing Ergometer, Deadlift and Blood flow restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 1 Jan 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreationally active adults (3 mo more days of moderate intensity physical activity per week, with at least some combination of aerobic and strength training).
Who cannot join
- Failure to achieve clearance for exercise participation via the Par-Q+ screening tool
- Currently pregnant or with 3 months post-partum
- Presence of chronic low back pain
- history of surgery to change the structure of joints within the lower extremity (joint replacement, osteotomy)
- Known blood clotting disorder or taking blood thinner medications
- Presence of peripheral vascular disease
- Presence of systemic or widespread pain disorder (fibromyalgia, chronic regional pain syndrome)
- Currently under activity limitations for any reason
Trial locations and contacts
1 site in 1 country.
United States1 site
Campbell University
Buies Creek, North Carolina, 27546
About this study
Blood-flow restriction training (BFR) is a technique utilized to provide the benefits of high intensity exercise (strength, power, hypertrophy) when applied to exercise intensities that are insufficient to produce these benefits without BFR. The technique involves the application of an occlusive cuff (similar in design to a blood pressure cuff) over the limb of an individual that is set to occlude arterial blood flow at a given percentage during exercise. BFR has demonstrated increased strength and muscle hypertrophy compared to control interventions in various populations including: healthy subjects, athletes, post-surgery, clinical rehabilitation, and older adults.
Most research on BFR has been conducted on single joint exercises and not exercises that exhibit more complex movements typically associated with daily activities. The early evidence of complex exercises combined with BFR suggests that strength and hypertrophy both improve, however more research needs to be conducted.
The purpose of this project is to determine if four weeks of BFR training combined with approach rowing and deadlifts increases strength, power, aerobic capacity, and muscle size. These results will be compared to an isovolumetric control.
Read the detailed description
INITIAL DATA COLLECTION (60-75 minutes) Measurements will be performed by a researcher blinded to group allocation. Height and weight will be measured with a stadiometer and calibrated scale.
Participant will sit to complete the following intake forms: Par-Q+, Numeric Pain Rating Scale, International Physical Activity Questionnaire- short form After sitting at least 5 minutes the following resting measures will be taken: resting heart rate, resting blood pressure
Thigh Circumference (supine): Markings will be made bilaterally at the lateral femoral condyle, proximal greater trochanter, and a line in an anterior to posterior direction 50% between these two landmarks. A circumferential measurement of the thigh will be taken three separate times at that 50% line for each leg.
Muscle Size: Measurements will be taken of the vastus lateralis and biceps femoris following the protocol established by Ruas et al using the GE LOGIC e, GE Healthcare, WI, USA). Superficial markings will be made to assist the researcher in locating desired anatomical location for measurement. Markings will be made bilaterally at the lateral femoral condyle, proximal aspect of greater trochanter, and a line in an anterior to posterior direction 50% between these two landmarks. Participants will lay supine for vastus lateralis and prone for biceps femoris measurement. The ultrasound transducer will be placed on the skin, utilizing a water-gel coupling agent, oriented perpendicular to the skin interface over the muscle of interest at the line that marks 50% of the distance between lateral femoral condyle and proximal greater trochanter. Images will be saved in the ultrasound device using participant identifier, muscle visualized, and date (example: BFR01_VL_05.01.19). Images will be exported to a computer for analysis using ImageJ software (National Institutes of Health, Bethesda, MD, USA).
Maximal Vo2: Oxygen consumption will be assessed on stationary rower (Concept2 Inc., Morrisville, VT) utilizing a metabolic cart and gas exchange (ParvoMedics, Provo, UT). Throughout the exercise test rating of perceived exertion (RPE) will be assessed within the final 10 seconds of each stage. Each participant will proceed throughout the various stages of the exercise test in a sequential fashion until test is terminated for one of the following reasons (1) participant requests to stop exercise test, (2) RPE reaches 10 out of 10, (3) participant fails to maintain desired Watts for that stage.
Maximal Deadlift Test:
Lower extremity strength will be assessed through an estimated one-repetition maximum (1-RM) deadlift with a dumbbell in each hand. Prior to performing the test each participant will receive instruction on proper technique for deadlift and the ability to perform practice repetitions as needed. The participant will begin with an estimated weight after consultation with research team member. The participant will grasp one dumbbell in each hand in an upright standing position and perform the maximum number of deadlifts possible. If the participant performs at least 1 repetition and no more than 9 repetitions of deadlifts they are finished with the deadlift test. If the participant performs more than 9 repetitions the resistance will be altered following the table below and the deadlift test will be performed again after 2-minute rest. Periods of testing and rest will alternate until the resistance provides at least 1 repetition but no more than 9 repetitions. The final deadlift weight and number of successful repetitions will be recorded and entered into the following equation to determine an estimated maximum deadlift resistance.
Randomization Participants will be randomly assigned to either the BFR group or the control group (CG), using block randomization. A predetermined random allocation of equal parts BFR and CG will be determined for each set of 10 participants (example: participants 1-10 will contain a random allocation of 5 to each intervention group, the same for participants 11-20 and 21-30). The block randomization will be performed by an individual not involved in this study (other than to randomize) with the result of the randomization being concealed until the after initial testing session. Both groups will participate in the same number of exercise sessions (2x per week for 4 weeks) and one final testing session.
EXERCISE SESSIONS (Study total = 4 hours) All exercise sessions will be conducted by a researcher who is not blinded to group allocation. Each group will complete two training sessions per week for four weeks. RPE will be recorded in the final seconds of each round of exercise. If participant does not complete the protocol for either rower or deadlift the resistance will be retained for future sessions. If participant reports <6/10 RPE at the final stage of either rower or deadlift the intensity for that exercise will be increased by 10% (watts or resistance respectively).
BFR Group
BFR will be conducted utilizing the Personal Tourniquet System (PTS) for BFR, Delfi Medical Innovations Inc (Vancouver , BC, Canada).
WARM-UP: Standard dynamic warm-up
BFR Set-up
- Placement of BFR sleeve and BFR cuffs around bilateral thighs.
- Participant will lay supine with cuffs in place.
- Researcher will initiate cuff inflation to measure arterial pressure
- After successful measurement of arterial pressure each cuff will be set to inflate to 80% occlusion for the exercise session.
- Participant will remain in BFR cuffs and move into the exercise session. Participants will complete a dynamic warm-up prior to starting the BFR exercise protocol. Upon completion of the protocol, the cuff will be deflated and removed. The participant will then walk for five minutes at a self-selected pace for a cool down.
Control Group
Participants will complete an identical dynamic warm-up as the BFR group prior to starting the CG exercise protocol. Upon completion of the protocol, the participant will then walk for five minutes at a self-selected pace for a cool down.
Final Testing Protocol (60-75 minutes)
Follow the same protocol as initial testing with all measurements taken by researcher blinded to group allocation. The researcher conducting final testing will not have been involved in the intervention period for any participant nor ask the participant about their experience or group allocation. Participants will also be instructed to not share their group allocation with the researcher collecting the final data.
- Conditions
- Healthy
- Being tested
- Seated Rowing Ergometer, Deadlift, Blood flow restriction
- Keywords
- Strength, Hypertrophy, Oxygen consumption
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seated Rowing ErgometerOther
Seated rowing exercise performed at a specific percentage of maximal Watts according to pre-intervention measures
DeadliftOther
Deadlift exercise performed with a set of dumbbell weights at a sepcific percentage of pre-intervention one-repetition maximum.
Blood flow restrictionOther
An occlusive cuff will be placed around each proximal thigh and inflated to 80% arterial occlusion during exercise sessions.
| Study group | Role | What they receive |
|---|---|---|
| Control Exercise Group | Active comparator | Participants allocated to the Control Exercise Group will participate in 8 total exercise sessions (2x per week for 4 weeks). Exercise sessions will include two exercise modalities 1)seated rowing ergometer and 2) dumbbell deadlifts. Exercise intensity will be individualized based upon preliminary testing with rowing at 80% maximal Watts, and deadlifts at 60% of one-repetition maximum. Receives: Other: Seated Rowing Ergometer; Other: Deadlift |
| Blood Flow Restriction and Exercise Group | Experimental | Participants allocated to the Control Exercise Group will participate in 8 total exercise sessions (2x per week for 4 weeks). Exercise sessions will include the application of blood flow restriction during two exercise modalities 1)seated rowing ergometer and 2) dumbbell deadlifts. Exercise intensity will be individualized based upon preliminary testing with rowing at 40% maximal Watts, and deadlifts at 30% of one-repetition maximum. Blow flow restriction will be applied at 80% occlusion during both exercise modalities. Receives: Other: Seated Rowing Ergometer; Other: Deadlift; Other: Blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle Size after 4 weeks
Cross-sectional measurement of muscle girth
Measured: after 4 weeks of intervention
Secondary outcomes (2)
Change in Maximal Oxygen Consumption after 4 weeks
Oxygen consumption will be assessed utilizing a metabolic cart and gas exchange during maximal effort seated rowing ergometry.
Measured: after 4 weeks of intervention
Change in Maximal Deadlift Strength after 4 weeks
One-repetition maximum strength will be assessed through incremental mass increases and estimation once participant can lift no more than 9 repetitions.
Measured: after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start1 Jun 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial with parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campbell University, Incorporated
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley Myers, Campbell University, Incorporated
- Investigators
- Bradley J Myers, DPT, DSc, Principal investigator, Campbell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983070
- Sponsor's protocol ID
- 491
- Status last verified
- Mar 2022
- First submitted
- 31 May 2019
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lower Extremity Blood Flow Restriction Training on Power, and Muscle Size.
- ClinicalTrials.gov ID
- NCT03983070
- Acronym / sponsor ID
- 491
- Conditions
- Healthy
- Keywords
- Strength, Hypertrophy, Oxygen consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Campbell University, IncorporatedUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 12 Jun 2019 (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 restriction training (BFR) is a technique utilized to provide the benefits of high intensity exercise (strength, power, hypertrophy) when applied to exercise intensities that are insufficient to produce these benefits without BFR. The technique involves the application of an occlusive cuff (similar in design to a blood pressure cuff) over the limb of an individual that is set to occlude arterial blood flow at a given percentage during exercise. BFR has demonstrated increased strength and muscle hypertrophy compared to control interventions in various populations including: healthy subjects, athletes, post-surgery, clinical rehabilitation, and older adults.
Most research on BFR has been conducted on single joint exercises and not exercises that exhibit more complex movements typically associated with daily activities. The early evidence of complex exercises combined with BFR suggests that strength and hypertrophy both improve, however more research needs to be conducted.
The purpose of this project is to determine if four weeks of BFR training combined with approach rowing and deadlifts increases strength, power, aerobic capacity, and muscle size. These results will be compared to an isovolumetric control.
Detailed description
INITIAL DATA COLLECTION (60-75 minutes) Measurements will be performed by a researcher blinded to group allocation. Height and weight will be measured with a stadiometer and calibrated scale.
Participant will sit to complete the following intake forms: Par-Q+, Numeric Pain Rating Scale, International Physical Activity Questionnaire- short form After sitting at least 5 minutes the following resting measures will be taken: resting heart rate, resting blood pressure
Thigh Circumference (supine): Markings will be made bilaterally at the lateral femoral condyle, proximal greater trochanter, and a line in an anterior to posterior direction 50% between these two landmarks. A circumferential measurement of the thigh will be taken three separate times at that 50% line for each leg.
Muscle Size: Measurements will be taken of the vastus lateralis and biceps femoris following the protocol established by Ruas et al using the GE LOGIC e, GE Healthcare, WI, USA). Superficial markings will be made to assist the researcher in locating desired anatomical location for measurement. Markings will be made bilaterally at the lateral femoral condyle, proximal aspect of greater trochanter, and a line in an anterior to posterior direction 50% between these two landmarks. Participants will lay supine for vastus lateralis and prone for biceps femoris measurement. The ultrasound transducer will be placed on the skin, utilizing a water-gel coupling agent, oriented perpendicular to the skin interface over the muscle of interest at the line that marks 50% of the distance between lateral femoral condyle and proximal greater trochanter. Images will be saved in the ultrasound device using participant identifier, muscle visualized, and date (example: BFR01_VL_05.01.19). Images will be exported to a computer for analysis using ImageJ software (National Institutes of Health, Bethesda, MD, USA).
Maximal Vo2: Oxygen consumption will be assessed on stationary rower (Concept2 Inc., Morrisville, VT) utilizing a metabolic cart and gas exchange (ParvoMedics, Provo, UT). Throughout the exercise test rating of perceived exertion (RPE) will be assessed within the final 10 seconds of each stage. Each participant will proceed throughout the various stages of the exercise test in a sequential fashion until test is terminated for one of the following reasons (1) participant requests to stop exercise test, (2) RPE reaches 10 out of 10, (3) participant fails to maintain desired Watts for that stage.
Maximal Deadlift Test:
Lower extremity strength will be assessed through an estimated one-repetition maximum (1-RM) deadlift with a dumbbell in each hand. Prior to performing the test each participant will receive instruction on proper technique for deadlift and the ability to perform practice repetitions as needed. The participant will begin with an estimated weight after consultation with research team member. The participant will grasp one dumbbell in each hand in an upright standing position and perform the maximum number of deadlifts possible. If the participant performs at least 1 repetition and no more than 9 repetitions of deadlifts they are finished with the deadlift test. If the participant performs more than 9 repetitions the resistance will be altered following the table below and the deadlift test will be performed again after 2-minute rest. Periods of testing and rest will alternate until the resistance provides at least 1 repetition but no more than 9 repetitions. The final deadlift weight and number of successful repetitions will be recorded and entered into the following equation to determine an estimated maximum deadlift resistance.
Randomization Participants will be randomly assigned to either the BFR group or the control group (CG), using block randomization. A predetermined random allocation of equal parts BFR and CG will be determined for each set of 10 participants (example: participants 1-10 will contain a random allocation of 5 to each intervention group, the same for participants 11-20 and 21-30). The block randomization will be performed by an individual not involved in this study (other than to randomize) with the result of the randomization being concealed until the after initial testing session. Both groups will participate in the same number of exercise sessions (2x per week for 4 weeks) and one final testing session.
EXERCISE SESSIONS (Study total = 4 hours) All exercise sessions will be conducted by a researcher who is not blinded to group allocation. Each group will complete two training sessions per week for four weeks. RPE will be recorded in the final seconds of each round of exercise. If participant does not complete the protocol for either rower or deadlift the resistance will be retained for future sessions. If participant reports <6/10 RPE at the final stage of either rower or deadlift the intensity for that exercise will be increased by 10% (watts or resistance respectively).
BFR Group
BFR will be conducted utilizing the Personal Tourniquet System (PTS) for BFR, Delfi Medical Innovations Inc (Vancouver , BC, Canada).
WARM-UP: Standard dynamic warm-up
BFR Set-up
- Placement of BFR sleeve and BFR cuffs around bilateral thighs.
- Participant will lay supine with cuffs in place.
- Researcher will initiate cuff inflation to measure arterial pressure
- After successful measurement of arterial pressure each cuff will be set to inflate to 80% occlusion for the exercise session.
- Participant will remain in BFR cuffs and move into the exercise session. Participants will complete a dynamic warm-up prior to starting the BFR exercise protocol. Upon completion of the protocol, the cuff will be deflated and removed. The participant will then walk for five minutes at a self-selected pace for a cool down.
Control Group
Participants will complete an identical dynamic warm-up as the BFR group prior to starting the CG exercise protocol. Upon completion of the protocol, the participant will then walk for five minutes at a self-selected pace for a cool down.
Final Testing Protocol (60-75 minutes)
Follow the same protocol as initial testing with all measurements taken by researcher blinded to group allocation. The researcher conducting final testing will not have been involved in the intervention period for any participant nor ask the participant about their experience or group allocation. Participants will also be instructed to not share their group allocation with the researcher collecting the final data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial with parallel groups
| Arm | Type | Receives |
|---|---|---|
| Control Exercise Group | Active comparator | Other: Seated Rowing Ergometer, Other: DeadliftParticipants allocated to the Control Exercise Group will participate in 8 total exercise sessions (2x per week for 4 weeks). Exercise sessions will include two exercise modalities 1)seated rowing ergometer and 2) dumbbell deadlifts. Exercise intensity will be individualized based upon preliminary testing with rowing at 80% maximal Watts, and deadlifts at 60% of one-repetition maximum. |
| Blood Flow Restriction and Exercise Group | Experimental | Other: Seated Rowing Ergometer, Other: Deadlift, Other: Blood flow restrictionParticipants allocated to the Control Exercise Group will participate in 8 total exercise sessions (2x per week for 4 weeks). Exercise sessions will include the application of blood flow restriction during two exercise modalities 1)seated rowing ergometer and 2) dumbbell deadlifts. Exercise intensity will be individualized based upon preliminary testing with rowing at 40% maximal Watts, and deadlifts at 30% of one-repetition maximum. Blow flow restriction will be applied at 80% occlusion during both exercise modalities. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Recreationally active adults (3 mo more days of moderate intensity physical activity per week, with at least some combination of aerobic and strength training).
Key exclusion criteria (8 listed)
- Failure to achieve clearance for exercise participation via the Par-Q+ screening tool
- Currently pregnant or with 3 months post-partum
- Presence of chronic low back pain
- history of surgery to change the structure of joints within the lower extremity (joint replacement, osteotomy)
- Known blood clotting disorder or taking blood thinner medications
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 |
|---|---|---|
| Seated Rowing ErgometerSeated rowing exercise performed at a specific percentage of maximal Watts according to pre-intervention measures | Other | Blood Flow Restriction and Exercise Group, Control Exercise Group |
| DeadliftDeadlift exercise performed with a set of dumbbell weights at a sepcific percentage of pre-intervention one-repetition maximum. | Other | Blood Flow Restriction and Exercise Group, Control Exercise Group |
| Blood flow restrictionAn occlusive cuff will be placed around each proximal thigh and inflated to 80% arterial occlusion during exercise sessions. | Other | Blood Flow Restriction and Exercise Group |
Primary outcome
Change in Muscle Size after 4 weeks
Time frame: after 4 weeks of intervention
Cross-sectional measurement of muscle girth
2 secondary outcomes
Change in Maximal Oxygen Consumption after 4 weeks
Time frame: after 4 weeks of intervention
Change in Maximal Deadlift Strength after 4 weeks
Time frame: after 4 weeks of intervention
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 14 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Bradley J Myers, DPT, DSc principal investigator
Campbell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seated Rowing Ergometer, Deadlift and Blood flow restriction in people with Healthy, run by Campbell University, Incorporated 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 1 inclusion and 8 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 14 Mar 2022. 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?
Change in Muscle Size after 4 weeks (time frame: after 4 weeks of intervention). 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 14 Mar 2022.