The Effects of Lower Extremity Blood Flow Restriction Training on Power, and Muscle Size.
Condition: Healthy
Study type: Interventional

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.
    

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

        1. Placement of BFR sleeve and BFR cuffs around bilateral thighs.

        2. Participant will lay supine with cuffs in place.

        3. Researcher will initiate cuff inflation to measure arterial pressure

        4. After successful measurement of arterial pressure each cuff will be set to inflate to
           80% occlusion for the exercise session.

        5. 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.
    

Intervention name(s): Seated Rowing Ergometer; Deadlift; Blood flow restriction
Intervention type(s): Other; Other; Other
Intervention description(s): Seated rowing exercise performed at a specific percentage of maximal Watts according to pre-intervention measures; Deadlift exercise performed with a set of dumbbell weights at a sepcific percentage of pre-intervention one-repetition maximum.; An occlusive cuff will be placed around each proximal thigh and inflated to 80% arterial occlusion during exercise sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial with parallel groups
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Strength; Hypertrophy; Oxygen consumption