Study of Alternative Exercise Therapies for Progressive Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This project will evaluate a new therapy for patients with a severe form of MS known as
      progressive MS. These patients are severely limited in their ability to walk and function in
      everyday life. The exercise therapy we are proposing is a recumbent cross trainer which
      allows patients to be seated and move their arms and legs at the same time against resistive
      foot pedals and arm levers. The recumbent cross trainer is safe and easy to use for people
      with disabilities and is more cost-effective compared with other rehabilitation equipment.
      Before the recumbent trainer can become part of mainstream MS therapy, it is important to
      determine if it is as effective as other exercise therapies in improving functional
      performance and quality of life. In this study we will compare the effects of the recumbent
      cross training with supported treadmill walking on functional and psychological outcomes.
      Further, since this is a new therapy for progressive MS patients, we also want to determine
      if it is safe and enjoyable to use.

      We hypothesize that recumbent stepper training will be safe and well-tolerated by progressive
      MS patients. Both training interventions will be beneficial in improving walking function and
      psychosocial outcomes. Recumbent stepper straining will likely have greater effects on upper
      extremity function, while supported treadmill walking will have greater effects on lower
      extremity function.
    

Detailed description: 
      We are proposing to evaluate the clinical utility and efficacy of a new therapeutic exercise
      modality for patients with progressive MS with severe functional impairments.

      Progressive MS patients have limited treatment options and reach higher disability levels at
      a faster rate than relapsing remitting MS patients. Consequently, finding solutions to
      maintain function and improve quality of life of patients with progressive MS is essential.

      A traditional training modality for patients with limited mobility is body-weight supported
      treadmill training (BWSTT). Our preliminary results support the efficacy of BWSTT in
      progressive MS patients; however, the financial burden and labour-intensive nature of BWSTT
      does not make it a viable option for most settings. For the aforementioned reasons, we are
      proposing total body recumbent stepper training (TBRST) as an alternative therapy for
      progressive MS patients with mobility impairments. TBRST is advantageous over BWSTT in that
      it has low set-up and maintenance costs, is easily used by patients with limited mobility and
      requires minimal assistance to operate. TBRST has the potential to become part of
      conventional MS treatment programs and could easily be incorporated into home and community
      settings. The primary aim of this investigation is to establish safety and satisfaction with
      TBRST in progressive MS patients. Second, we plan to determine if TBRST is as effective as a
      BWSTT as a therapeutic modality.

      Twenty patients with progressive MS (primary and secondary) of high disability level (EDSS
      6.0-8.0) will be recruited to participate in this study. Both primary and secondary MS
      patients will be included due to similarities in disease progression and a lack of available
      alternative treatments for this population. Patients will be randomized to either the TBRST
      or BWSTT intervention; there will be 10 patients in each group. Patients in the TBRST program
      will train using the Nustep (TRS 4000) recumbent cross trainer. The recumbent cross trainer
      allows patients to move their legs in a natural stepping motion with bilateral reciprocal
      movement of the arms from a seated position. Foot straps, leg stabilizers and hand
      stabilizers may be used for added control and proper body alignment when necessary. Patients
      in the BWSTT group will exercise using the Woodway Loco-system which allows a portion of the
      patient's body-weight to be off-loaded by an overhead pulley system. Treadmill therapists
      will guide the patients' legs through a proper gait motion and assist with lower limb
      control.

      Participants in both interventions will complete three weekly exercise sessions of 30min, for
      the duration of 12 weeks. Perceived exertion will be used as an indicator of exercise
      intensity and will guide program progression. Both intervention groups will maintain a
      perceived exertion of 5-7 on the Borg CR10 Scale throughout the exercise program. All
      patients will be evaluated at baseline and following 12 weeks on a variety of outcome
      measures. Primary outcome measures will be safety and satisfaction with TBRST. Secondary
      outcomes will be functional ability using the EDSS and MSFC, quality of life using the
      MSQOL-54, fatigue using the MFIS and MS self-efficacy using the MSSE. The proposed research
      will take place over one year with enrolment and intervention programs commencing in a graded
      manner.
    

Intervention name(s): Body-weight supported treadmill training; Total body recumbent stepper training
Intervention type(s): Other; Other
Intervention description(s): Patients will undergo training using the Woodway Loco-system which consists of a treadmill with an overhead pulley system connected to a support harness. BWSTT allows patients with limited mobility to safely walk upright on a treadmill with a portion of their body weight counter balanced. Three trainers will be required to assist with the BWSTT program. Two trainers will be positioned at the lower limbs to manually guide the participant through a proper gait motion and provided lower limb control. A third trainer will stand behind the participant to provide trunk support and assist with weight shifting.; Patients will train using the Nustep T4 (TRS 4000) which is a recumbent cross trainer that provides a full body workout in a seated position. The Nustep trainer allows patients to achieve a natural stepping motion against graded loads with bilateral reciprocal movement of the arms. Recumbent training is safe and easily accessible for patients of all ability levels with a swivel chair to aid in patient transfers. Foot straps, leg stabilizers and hand stabilizers may be used for added control and proper body alignment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: exercise; rehabilitation; progressive multiple sclerosis; functional ability; fatigue; quality of life