Effect of Physical ACtivity in Fingolimod Treated patiEnts (PACE) With Relapsing-remitting Multiple Sclerosis

Phase 4TerminatedNCT01490840

Novartis Pharmaceuticals178 enrolled

Overview

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

In this study, it was planned to randomize 226 participants. However, only 178 participants were randomized during a timeframe of 2 years and 8 months. Therefore, the study was terminated due to slow enrollment and low participant compliance to the physical training schedule.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

178

Conditions

Fatigue in Multiple Sclerosis

Interventions

Physical exerciseOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (32)

Outcomes

Primary Outcomes

Change From Baseline in Fatigue as Measured by the Modified Fatigue Impact Scale (mFIS ).

The mFIS provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. It is a 21-item, structured, self-report questionnaire that generally can be completed with little or no intervention from an interviewer. The mFIS score ranged from 0 (not tired) to 84 (tired). A negative change from baseline indicates improvement.

Time frame: Baseline, 6 months

Secondary Outcomes

Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Sit-to-stand Test

The Sit to Stand Test is a functional outcome measure of the lower-extremity muscle power. The test was performed 3 times with one minute rest in between. The best attempt out of three was used for the analysis. A positive change from baseline indicates improvement.

Time frame: baseline, 6 months

Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Change in Leg Strength and Trunk Strength

Isometric and dynamic muscular strength was measured by an Isomed 2000 isometric measurement device (knee flexion/tension, trunk flexion/extension). Isomed 2000 device measures muscular flexion and tension under standardized training conditions. A positive change from baseline indicates improvement.

Time frame: baseline, 6 months

Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Leg Strength Endurance

Time frame: baseline, 6 months

Change From Baseline in Quality of Life as Measured by the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Novartis Investigative Site

Dortmund, Germany, Germany

Novartis Investigative Site

Leipzig, Germany, Germany

Novartis Investigative Site

Aachen, Germany

Novartis Investigative Site

Alzenau in Unterfranken, Germany

Novartis Investigative Site

Aschaffenburg, Germany

Novartis Investigative Site

Bad Mergentheim, Germany

Novartis Investigative Site

Bamberg, Germany

Novartis Investigative Site

Bayreuth, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

...and 22 more locations