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

NCT01490840 | Terminated Phase 4 Results

• 2 other identifiers: CFTY720DDE072011-002969-38
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 32

Brief Summary

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

Conditions

Fatigue in Multiple Sclerosis

Keywords

Fatigue; MS; Multiple Sclerosis; Exercise; Physical activity; Physical training; Fingolimod

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 months

Secondary Outcomes (8)

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

  baseline, 6 months

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

  baseline, 6 months

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

  baseline, 6 months

• 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

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

  Baseline, 6 months

Study Arms (2)

E-training

EXPERIMENTAL

Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.

Other: Physical exercise

Waiting

EXPERIMENTAL

Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 months waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.

Other: Physical exercise

Interventions

Physical exercise OTHER

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.

E-training; Waiting

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (32)

Novartis Investigative Site

Dortmund, Germany, 44135, Germany

Location

Novartis Investigative Site

Leipzig, Germany, 04299, Germany

Location

Novartis Investigative Site

Aachen, 52062, Germany

Location

Novartis Investigative Site

Alzenau in Unterfranken, 63755, Germany

Location

Novartis Investigative Site

Aschaffenburg, 63739, Germany

Location

Novartis Investigative Site

Bad Mergentheim, 97980, Germany

Location

Novartis Investigative Site

Bamberg, 96052, Germany

Location

Novartis Investigative Site

Bayreuth, 95445, Germany

Location

Novartis Investigative Site

Berlin, 10437, Germany

Location

Novartis Investigative Site

Berlin, 10625, Germany

Location

Novartis Investigative Site

Berlin, 10691, Germany

Location

Novartis Investigative Site

Berlin, 12587, Germany

Location

Novartis Investigative Site

Berlin, 13347, Germany

Location

Novartis Investigative Site

Bielefeld, 33647, Germany

Location

Novartis Investigative Site

Bochum, 44787, Germany

Location

Novartis Investigative Site

Böblingen, 71032, Germany

Location

Novartis Investigative Site

Erbach im Odenwald, 64711, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Frankfurt, 65929, Germany

Location

Novartis Investigative Site

Hamburg, 22179, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Jena, 07740, Germany

Location

Novartis Investigative Site

Kassel, 34121, Germany

Location

Novartis Investigative Site

Potsdam, 14471, Germany

Location

Novartis Investigative Site

Prien am Chiemsee, 83209, Germany

Location

Novartis Investigative Site

Regensburg, 93053, Germany

Location

Novartis Investigative Site

Siegen, 57076, Germany

Location

Novartis Investigative Site

Sinsheim, 74889, Germany

Location

Novartis Investigative Site

Stuttgart, 70174, Germany

Location

Novartis Investigative Site

Stuttgart, 70178, Germany

Location

Novartis Investigative Site

Teupitz, 15755, Germany

Location

Novartis Investigative Site

Unterhaching, 82008, Germany

Location

Related Publications (1)

• Maurer M, Schuh K, Seibert S, Baier M, Hentschke C, Streber R, Tallner A, Pfeifer K. A randomized study to evaluate the effect of exercise on fatigue in people with relapsing-remitting multiple sclerosis treated with fingolimod. Mult Scler J Exp Transl Clin. 2018 Feb 14;4(1):2055217318756688. doi: 10.1177/2055217318756688. eCollection 2018 Jan-Mar.

  PMID: 29479457 DERIVED

MeSH Terms

Conditions

Fatigue; Multiple Sclerosis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Study Director
• Organization: Novartis

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: December 13, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 12, 2016
• Results First Posted: May 12, 2016

Record last verified: 2016-04

Locations

DE (32)