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The Effects of Lower Extremity Blood Flow Restriction Training on Power, and Muscle Size.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03983070
Recruitment Status : Suspended (Covid-19. No in-person study procedures are currently allowable by the overseeing IRB.)
First Posted : June 12, 2019
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Bradley Myers, Campbell University, Incorporated

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Healthy Other: Seated Rowing Ergometer Other: Deadlift Other: Blood flow restriction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial with parallel groups
Masking: Single (Outcomes Assessor)
Masking Description: Blinded researcher will perform preliminary and outcomes measures.
Primary Purpose: Treatment
Official Title: The Effects of Lower Extremity Blood Flow Restriction Training on Power, and Muscle Size.
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Arm Intervention/treatment
Active Comparator: Control Exercise Group
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.
Other: Seated Rowing Ergometer
Seated rowing exercise performed at a specific percentage of maximal Watts according to pre-intervention measures

Other: Deadlift
Deadlift exercise performed with a set of dumbbell weights at a sepcific percentage of pre-intervention one-repetition maximum.

Experimental: Blood Flow Restriction and Exercise Group
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.
Other: Seated Rowing Ergometer
Seated rowing exercise performed at a specific percentage of maximal Watts according to pre-intervention measures

Other: Deadlift
Deadlift exercise performed with a set of dumbbell weights at a sepcific percentage of pre-intervention one-repetition maximum.

Other: Blood flow restriction
An occlusive cuff will be placed around each proximal thigh and inflated to 80% arterial occlusion during exercise sessions.




Primary Outcome Measures :
  1. Change in Muscle Size after 4 weeks [ Time Frame: after 4 weeks of intervention ]
    Cross-sectional measurement of muscle girth


Secondary Outcome Measures :
  1. Change in Maximal Oxygen Consumption after 4 weeks [ Time Frame: after 4 weeks of intervention ]
    Oxygen consumption will be assessed utilizing a metabolic cart and gas exchange during maximal effort seated rowing ergometry.

  2. Change in Maximal Deadlift Strength after 4 weeks [ Time Frame: after 4 weeks of intervention ]
    One-repetition maximum strength will be assessed through incremental mass increases and estimation once participant can lift no more than 9 repetitions.


Other Outcome Measures:
  1. Change in Numeric Pain Rating after 4 weeks [ Time Frame: after 4 weeks of intervention ]
    Numeric Pain Rating Scale (0-10). Participants will rate their present experience of pain from 0 "no pain" to 10 "worst imaginable pain." Participants can select any whole number, higher scores represent more intense pain experience. This scale contains only one verbal question.

  2. Change in International Physical Activity Questionnaire - Short Form after 4 weeks [ Time Frame: after 4 weeks of intervention ]
    Assessment of physical activity over 7 day period

  3. Change in Resting Heart Rate after 4 weeks [ Time Frame: after 4 weeks of intervention ]
    After 5 minutes of seated rest heart rate will be assessed

  4. Change in Resting Blood Pressure after 4 weeks [ Time Frame: after 4 weeks of intervention ]
    After 5 minutes of seated rest blood pressure will be assessed

  5. Chang in Thigh circumference after 4 weeks [ Time Frame: after 4 weeks of intervention ]
    Cicumferential measures of the thigh 50% of the way between greater trochanter and lateral femoral condyle



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Recreationally active adults (3 mo more days of moderate intensity physical activity per week, with at least some combination of aerobic and strength training).

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983070


Locations
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United States, North Carolina
Campbell University
Buies Creek, North Carolina, United States, 27546
Sponsors and Collaborators
Campbell University, Incorporated
Investigators
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Principal Investigator: Bradley J Myers, DPT, DSc Campbell University
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Responsible Party: Bradley Myers, Assistant Professor, Campbell University, Incorporated
ClinicalTrials.gov Identifier: NCT03983070    
Other Study ID Numbers: 491
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bradley Myers, Campbell University, Incorporated:
Strength
Hypertrophy
Oxygen consumption