Blood Flow Restriction and Veterans with Multiple Sclerosis (BRaVe-MS) and Advanced Disability: Protocol for a Randomized Controlled Trial.

Abstract

The purpose of this study will be to determine the efficacy of low intensity lower extremity resistance training with and without blood flow restriction on quadriceps muscle strength and thickness in veterans with advanced multiple sclerosis (MS). This will be an assessor-blinded, 2-group (1 to 1 allocation) randomized controlled trial targeting an enrollment of 58 participants with advanced MS as defined by Patient-Determined Disease Steps scale levels 4 to 7. Both groups will complete 10weeks of twice weekly low-load resistance training (20% to 30% of 1-repetition max) targeting knee and hip extension, knee flexion, and ankle plantarflexion. The intervention group will perform all training using blood flow restriction, with limb occlusion pressures between 60% to 80% of maximal limb occlusion pressure. Primary outcomes will be quadriceps muscle strength and thickness. Secondary outcomes will include knee flexion and ankle plantarflexion strength, functional mobility, physical activity, and patient-reported measures. All outcomes will be assessed at baseline before the intervention, immediately after the intervention, and at a 2-month follow-up assessment. The change between groups post-intervention and after the 2-month follow-up will be reported for all outcomes. All analyses will assume a 2-sided test of hypothesis (α= .05). There is very little evidence for the efficacy of exercise interventions in people with MS who have advanced mobility disability. Resistance training with blood flow restriction may be an important approach for people with advanced MS who may not tolerate more conventional, moderate-to-high intensity resistance training. The results of this study will inform clinicians regarding exercise decisions for people with advanced MS and future investigations on the role of blood flow restriction in people with MS.