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

Fatigue in Multiple Sclerosis Clinical Trial

— PACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490840
• Other study ID #: CFTY720DDE07
• Secondary ID: 2011-002969-38
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2011
• Last updated: December 9, 2014
• Start date: November 2011
• Est. completion date: July 2014

Study information

• Verified date: December 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• Fatigue in Multiple Sclerosis
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Physical exercise
Strength training exercises are performed against own body weight or with training aids like elastic rubber bands or gymballs. 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.

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Aachen
Germany	Novartis Investigative Site	Alzenau
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	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Böblingen
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Dortmund
Germany	Novartis Investigative Site	Erbach
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Prien
Germany	Novartis Investigative Site	Regensburg
Germany	Novartis Investigative Site	Siegen
Germany	Novartis Investigative Site	Sinsheim
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Teupitz
Germany	Novartis Investigative Site	Unterhaching

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fatigue from baseline to 6 month and 12 months 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 will be performed at - screening, baseline, week 13, week 26, week 35 and week 53	Baseline to 6 months	No
Secondary	Change in isomentric and dynamic muscular strength as measured by changes in knee and trunk flexion and tension by Isomed 2000 isometric measurement device	Isometric and dynamic muscular strength measured by Isomed 2000 isometric measurement device (knee flexion/tension, trunk flexion/extension) and sit-to-stand-test.; Isomed 2000 device measures muscular flexion and tension under standardized training conditions.; The Sit to Stand Test is a functional outcome measure of the lower-extremity muscle power. The test will be performed 3 times with one minute rest in between, the best attempt out of three is used for the analysis.	From baseline to 6 months and 12 months	No
Secondary	Change in quality of life from baseline to 6 and 12 months as measured by the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS)	The Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS) consists of 38 items, 28 of which are the basis for computation of five subscale scores reflecting major dimensions of health-related quality of life (HRQoL) in MS: Fatigue/Thinking (4 items), Mobility lower limb (5 items), Mobility upper limb (5 items), Social function (6 items) and Mood (eight items). Internal consistency, retest reliability and validity of the HAQUAMS are not affected by cognitive impairment in MS	Baseline to 6 months	No
Secondary	Change in fatigue from baseline to 6 and 12 months as measured by the WEIMuS (Würzburg Fatigue Inventory for MS)	The WEIMuS (Würzburg Fatigue Inventory for MS) scale is a validated self-assessment instrument to quantify the degree of fatigue. The scale consists of 17 items with 5 categories that are scored from '0' to '4', with the total sum score ranging from 0 to 68; higher scores indicate higher degrees of fatigue. Subscores for cognitive and physical fatigue are ranging from 0 to 36 and from 0 to 32, respectively.	Baseline to 6 months and 12 months	No
Secondary	Change in depression from baseline to 6 and 12 months as measured by the Beck Depression Inventory Second Edition (BDI-II)	The Beck Depression Inventory Second Edition (BDI-II) is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders Fourth Edition. Scoring: Each of the 21 items corresponding to a symptom of depression is summed to give a single score for the BDI-II. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.	Baseline to 6 months and 12 months	No
Secondary	Change in aerobic capacity from baseline to 6 and 12 months as measured by a physical endurance spiroergometry on a treadmill	Physical endurance spiroergometry will be accomplished. Ergometry will be assessed according to national guidelines of the German society for sports medicine. Ergometry is a combined examination of circulation and lung function and will be performed as a submaximal or maximal test depending on the patient´s individual performance	Baseline to 6 and 12 months	No