Effects of Low-intensity Interval Walking With Blood Flow Restriction on Functional Capacity in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the safety, feasibility and initial efficacy of an
      interval-based walking training at low speed performed with blood flow restriction (BFR) on
      gait speed and functional impairments in patients with Multiple Sclerosis (MS).

      Patients with severe MS will be recruited at outpatient rehabilitation clinics (University
      Hospital of Ferrara). Eligible participants will be randomized to interval walking training
      with BFR (the experimental group) or conventional exercise therapy (the control group)
      according to a blocked-randomization stratified by gender with 1:1 ratio. Both groups will
      receive 12 rehabilitative sessions over 6 weeks, for a 2 sessions/week pattern.

      The experimental group will undergo interval-based walking training at a slow speed according
      to a walk:rest ratio of 1:1 for a total of 6 minutes, to be repeated 5 times. Blood flow
      restriction, applied to the proximal thigh, will be set at a maximum of 40% of systolic blood
      pressure. The control group will be treated with conventional therapy.

      Changes in gait speed, endurance, balance, lower limbs strength and quality of life will be
      assessed at baseline, at the end of training, and at follow up.

      The proposed training modality has never been tested in patients with MS and, if the
      hypotheses were supported by the results, might be a novel tool to improve muscle strength
      with a positive impact on gait disabilities, balance and quality of life for patients with
      MS.
    


Intervention name(s): BFR-Walking; Conventional therapy
Intervention type(s): Other; Other
Intervention description(s): Participants will perform 12 training sessions over 6 weeks, including a 10-minute warm up and cool down period. Patients will perform 5 six-minute bouts of over ground intermittent walking exercise (1-minute walk/rest) with their habitual walking device at a prescribed speed maintained by a metronome, starting from 60 steps/minute. A fixed resting period of 3 minutes will follow each walking bout. During walking, participants will wear BFR bands at both tights. Before every walking bout, the bands will be tightened at a low intensity (max 40% of blood systolic pressure) and untied at the end of every walking bout when patients will be asked to grade their RPE (Borg Scale). Walking speed will be weekly increased by 3 steps/minute, if the previous level was well-tolerated by the patient.; Participants will perform 12 training sessions over 6 weeks. Patients will perform assisted over-ground walking for a total of around 40 minutes, inserted between a 10-minute warm-up and cool-down period. The patient will be encouraged by the same experienced physiotherapist to walk back and forth on 50-meter indoor flat corridor with their habitual walking device. Patient will be asked to walk without stopping until reaching an effort corresponding to a value of 8 out of 10 of the rating of perceived exertion (Borg scale). When the exertion level is reached, the patients will be allowed to rest sitting on a chair if necessary; after a suitable rest period, when patients express sufficient desire to start again, the training will restart
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center pilot randomized parallel group clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: mobility; exercise therapy; blood flow restricted exercise; rehabilitation