The Back Exercises to Neutralize Disability Study
Condition: Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      A pilot randomized control trial (RCT) to generate effect sizes on the effects of blood flow
      restricted exercise on trunk extensor cross-sectional area (primary outcome), strength and
      endurance, whole body and regional lean mass and bone density, as well as the rate of
      recurrence of LBP (secondary outcomes).
    

Detailed description: 
      This is a single-blinded, comparison-control group, single-center study of the effects of
      exercise with and without blood flow restriction applied to the appendicular limbs on safety,
      body composition (i.e., muscle mass), muscle strength, muscle endurance, whole body and
      regional lean mass and bone density, and back pain and disability in male and female subjects
      aged 18-50 years with recurrent low back pain and poor to moderate trunk extensor muscle
      endurance.

      Up to 50 subjects (2 arms) will be randomized in a 1:1 ratio to receive 10-weeks of
      resistance exercise training with (group 1) or without blood flow restriction (group 2).
      Randomization will be stratified by sex.

      This study will have a screening period of 21 days (day -21 to day -1, screening and baseline
      measures), a 10-week exercise treatment period (day 1 to day 70) and a 36-week follow up
      period after the last exercise session (day 70 to day 322). The total duration of the study
      from first exercise session will be approximately 46 weeks. Baseline measures for muscle size
      (via MRI), muscle strength, muscle endurance, whole body and regional lean mass and bone
      density (via DEXA), and measures of back pain and disability will be obtained between day -21
      to -1.

      Primary Endpoint: The primary endpoint is percent change in trunk extensor muscle
      cross-sectional area measured by MRI at week 10 (study day 70) after start of exercise
      training.

      Secondary: The secondary endpoints include:

        -  Muscle strength

        -  Muscle endurance (time to task failure)

        -  Whole body and regional lean mass by DEXA

        -  Whole body and regional bone density by DEXA

        -  Pain

        -  Disability

        -  Safety

        -  Treatment acceptability Procedures and Assessments Efficacy measures (MRI, muscle
           strength, muscle endurance, lean mass, bone density, pain, and disability) will be
           obtained at screening and at week 10 (day 70) and week 20 (day 154).

      Safety of blood flow restricted exercise will be assessed based on adverse event findings and
      monitoring. Subjects will be asked to monitor and report all adverse events (AEs) experienced
      from the time the informed consent is signed until the end-of-study visit.

      Treatment acceptability will be determined by administering the Treatment Evaluation
      Inventory survey at the end of the fourth and sixteenth exercise sessions.
    

Intervention name(s): Exercise with blood flow restriction; Exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Low load resistance exercise performed with an external pressure cuff applied over both legs or both arms during respective leg and arm exercises.; Low load resistance exercise performed with no external pressure cuff applied to the appendicular limbs.
Other intervention name(s): Kaatsu Training with Blood Flow Restricted Exercise; Resistance exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise