Effect of Physical ACtivity in Fingolimod Treated patiEnts (PACE) With Relapsing-remitting Multiple Sclerosis
Condition: Fatigue in Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Fatigue
Intervention: Physical exercise
Intervention description: Strength training exercises are performed against own body weight or with training aids like elastic rubber bands or gym balls. All exercises are home-based. To increase balance and core stability, a subset of exercises is performed on shaky ground and/or one-legged. Exercise intensity, duration and frequency are individually assigned by a sports therapist. For each muscle group, a set of exercises of increasing difficulty allows for individual and progressive training adaption. Therapists can choose from an exercise database of approximately 150 different strength exercises with different graduation.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Fatigue; MS; Multiple Sclerosis; Exercise; Physical activity; Physical training; Fingolimod

Summary:

      This study evaluated the effect of an individualized web-based physical training in
      fingolimod -treated patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria

          -  Patients with Expanded Disability Status Scale (EDSS) score of 0-3.5 (including)

          -  Immunomodulatory treatment with prescribed fingolimod for at least one month prior to
             baseline

          -  Fatigue score assessed by mFIS of equal or greater than 14 at screening

          -  Neurologically stable with no evidence of relapse within 30 days prior to inclusion
             date

        Exclusion Criteria:

          -  Patients who have been treated with:

               -  systemic corticosteroids or immunoglobulins within 1 month prior to
                  randomization;

               -  immunosuppressive medications such as azathioprine, cyclophosphamide, or
                  methotrexate within 3 months prior to randomization;

               -  monoclonal antibodies (including natalizumab) within 3 months prior to
                  randomization;

               -  mitoxantrone within 6 months prior to randomization

               -  cladribine at any time.

          -  Patients with any medically unstable condition, as assessed by the primary treating
             physician at each site.

          -  Patients with any of the following cardiovascular conditions :

               -  history of cardiac arrest;

               -  history of myocardial infarction or with current unstable ischemic heart disease;

               -  history of angina pectoris due to coronary spasm or history of Raynaud syndrome

               -  Heart failure (NYHA III-IV) or any severe cardiac disease as determined by the
                  investigator;

               -  history or presence of a second-degree AV block, Type II or a third-degree AV

               -  block

               -  patients receiving Class Ia (ajmaline, disopyramide, procainamide, quinidine) or

               -  III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide,
                  azimilide,

               -  dofelitide);

               -  proven history of sick sinus syndrome or sino-atrial heart block;

               -  uncontrolled hypertension

          -  Clinically relevant internal disease (e.g. uncorrected anemia) or orthopedic diseases
             (e.g. scoliosis) that might interfere with physical training

          -  Any severe disability or clinical impairment that can prevent the patient to meet all
             study requirements at the investigator's discretion

        Other protocol-defined inclusion/exclusion criteria may apply.