MSFrontier

PACE

A 6-month, Multicenter, Randomized, Controlled Parallel Group Study to Evaluate the Effect of Physical Training on Fatigue in Patients With Relapsing-remitting Multiple Sclerosis Treated With Fingolimod, Followed by a 6 Month Optional Extension Phase
Stopped earlyPhase 4Relapsing MSNCT014908402011-002969-38

What it found

Stopped early

The trial ended early for another reason (see below).

Reason given: The study stopped due to slow enrollment and low participant compliance.

What was tested

Treatment tested

Results by group

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

Baseline, 6 months

GroupValueIntervalNumber analysed
E-training-3.57 score on a scale-6.81–-0.3456
Waiting-2.10 score on a scale-4.69–0.4983

E-training

-3.57

Waiting

-2.1

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
E-training945 (5.3%)
Waiting849 (10.7%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

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

    Baseline, 6 months

    Thinking and memoryFatigue

  • To decrease the level of fatigue via a structured physical e-training vs. no training in Gilenya-treated RRMS patients after 6 months; assessed by the mFIS fatigue scale.

    Fatigue

Other measures (9)

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

    baseline, 6 months

    Physical function

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

    baseline, 6 months

    Physical function

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

    baseline, 6 months

    Physical function

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

    Baseline, 6 months, 12 months

    FatigueWalking and mobilityArm and hand functionMood and sleepQuality of life (reported by participants)

  • Change From Baseline in Fatigue as Measured by the WEIMuS (Würzburg Fatigue Inventory for MS)

    Baseline, 6 months

    Thinking and memoryFatigue

  • Change From Baseline in Depression as Measured by the Beck Depression Inventory Second Edition (BDI-II)

    Baseline, 6 months

    Mood and sleep

  • Change From Baseline in Aerobic Capacity (VO2max) as Measured by a Physical Endurance Spiroergometry on a Treadmill

    Baseline, 6 months

    Physical function

  • Change From Baseline in Peak Expiratory Flow as Measured by a Physical Endurance Spiroergometry on a Treadmill

    Baseline, 6 months

  • • To evaluate the effect of structured physical e-training vs. no training on isometric and dynamic muscular strength measured by Isomed 2000 isometric measurement device (knee flexion/tension, trunk flexion/extension) and sit-to-stand-test.

    Physical function

Who could take part

Relapsing MS · 18 to 65

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

Loading reviews and guidelines…

Related trials

History

    1. Started

      Nov 2011

    2. Main results due

      Jul 2014

    3. Finished

      Jul 2014

    4. Results posted

      May 2016

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error