Intensive Multimodal Training for Persons With MS
Condition: Rehabilitation; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the safety, feasibility and preliminary effects of a
      high-intensity rehabilitative multimodal training protocol carried out on treadmill on
      walking efficacy, mobility, balance, executive function, fatigue and health-related quality
      of life in a sample of persons with moderate to severe MS deficit of mobility compared to a
      control group that received a strengthening program of similar intensity.
    

Detailed description: 
      Persons with multiple sclerosis can have various deficits, affecting many aspects of physical
      and cognitive functioning often leading to low levels of physical activity in daily life.
      These include poor endurance, muscle weakness, incoordination and poor balance and cognitive
      deficits that can all lead to persistent mobility difficulties in daily life.

      Given the importance of exercise and physical activity for persons with multiple sclerosis
      that are already moderately to severely hampered by their locomotor ability and balance, the
      setting up of intense functional mobility training that targets the main deficits, in
      adjunction to a clinical rehabilitation usual care and under close supervision, may be a
      viable way of increasing the level of physiological health and give a basis for the persons
      to start their own activity pursuit outside of the rehabilitation clinic. Treadmill walking
      has several benefits for mobility rehabilitation. First, it is a everyday task, walking.
      Second it lends itself well to a dual task paradigm where other aspects of mobility, such as
      equilibrium and cognitive factors can be addressed during walking. Third, even persons with
      severe walking limitations can train walking at various speeds when on treadmill, holding
      onto handrails and using safety harnesses that minimize the possibility of adverse events
      during training. Further, the treadmill paradigm lends itself well to training with
      progressive task difficulty, numerous rhythmic repetitions, and importantly it can include an
      aerobic component to improve cardiorespiratory fitness. All of which should lead to improved
      submaximal exercise tolerance and endurance, more functional mobility and consequently
      increased ability to carry out activities of daily living.

      Methods: A consecutive sample of 42 People with Multiple Sclerosis (PwMS) were recruited from
      the outpatient/inpatient rehabilitation service of the Don Gnocchi Foundation. The study was
      conducted in accordance with the Declaration of Helsinki and was approved by the ethics
      committee of the Don Gnocchi Foundation. Subjects signed an informed consent form before the
      beginning of the study.

      The study design was a two arm randomized 2:1 controlled trial (see study flow chart in
      Figure 1).

      The participants were assessed before and after the rehabilitation period by researchers
      blinded to group assignment.

      Participants in both groups received 15- 20 treatments sessions lasting 30 minutes 5 times
      per week by experienced physical therapists trained for the study. All participants also
      followed their usual rehabilitation care protocols as planned.
    

Intervention name(s): Treadmill; Resistance
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the experimental group received supervised treadmill training, 4-5 sessions per week. The treatment protocol was aimed at improving participants' resistance, walking velocity, balance and cognitive functions during motor and cognitive (dual) tasks. The treadmill training was carried out without body weight support but if needed the participants were attached to a safety harness.; Participants in the control group were treated with Resistance exercises, 4-5 sessions per week. The treatment protocol was aimed at improving strength in muscles involved in walking (hip abductors, quadriceps, plantar flexors, dorsal flexors) according to current guidelines from the American College of Sports Medicine (2009). Three sets of 10 repetitions were performed bilaterally with appropriate weights for each exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intervention; Multiple sclerosis; Treadmill; Mobility