A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Participants With Multiple Sclerosis (ACTIMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01065090
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : April 13, 2015
Biogen Idec A/S
Information provided by (Responsible Party):

Brief Summary:
The primary objective of the investigation is to determine whether the addition of exercise (resistance training or modified physiotherapy) improves functional capacity in Multiple Sclerosis (MS) participants undergoing Disease Modifying Therapy (DMT) treatment. We hypothesize that the Progressive Resistance Training (PRT) will improve functional capacity without increasing the risk of relapses in participants undergoing standard DMT treatment. The secondary objectives are to determine whether exercise (resistance training or physiotherapy) improves fatigue, mood and Quality of Life (QoL) in MS participants undergoing DMT treatment. Also as a secondary objective, the study aims at determining whether exercise (resistance training or modified physiotherapy) has an impact on Expanded Disability Status Scale (EDSS), time to first relapse, number of relapse free participants, and immunological factors. We hypothesize that the exercise (resistance training) will improve fatigue, mood and QoL and that an impact on immunological factors will be seen in participants even though they are undergoing standard DMT treatment.

Condition or disease

Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Patients With Multiple Sclerosis
Study Start Date : June 2010
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

one group will receive resistance training and one group the normal physiotherapeutic treatment
one group will receive resistance training and one group the normal physiotherapeutic treatment

Primary Outcome Measures :
  1. Change of muscle strength [ Time Frame: Baseline, 12 months, 15 months and 18 months. ]
    Measured by chair stand test

Secondary Outcome Measures :
  1. Changes of speed of walking [ Time Frame: Baseline, 12 months and 18 months ]
    Measured by 6 min walk test, Symbol Digit Modalities Test (SDMT), Quality of Life (QoL, SF26, physical part) and Multiple Sclerosis Walking Scale (MSWS)

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients on AVONEX 3-6 months after treatment initiation

Key Inclusion Criteria:

  • Age > 18 years and age < 65 years at screening
  • Relapsing Remitting Multiple Sclerosis (RRMS) diagnosis according to McDonald Criteria
  • Subjects who have been on Avonex treatment for 3-6 months prior to screening
  • A signed informed consent form (ICF) is obtained before any study activity
  • EDSS > 1.5 and < 5 at Screening with at least a score of 1 in pyramidal function
  • Are able to walk at least 100 meters
  • Are able to transport themselves to and from the training facility

Key Exclusion Criteria:

  • Suffer from dementia, alcoholism or if they use pacemaker
  • Have any serious medical co-morbidities like cardiovascular, respiratory, orthopedic or metabolic diseases
  • Have had a MS relapse within an eight week period prior to the study start
  • Are pregnant
  • Have trained systematic resistance training for one day or more each week in the prior 3 months before study start.
  • Only able to participate in less than 70% of the planned training sessions.
  • Suffers from major depression

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01065090

Coordinating Research Site
NSW, Australia
Research Site
Odense, Denmark
Research Site
Sønderborg, Denmark
Research Site
Vejle, Denmark
Research Site
Jyväskylä, Finland
Research Site
Oulu, Finland
Research Site
Pori, Finland
Research Site
Seinäjokï, Finland
New Zealand
Research Site
Hamilton, New Zealand
Research Site
Drammen, Norway
Research Site
Ullevål, Norway
Research Site
Gothenburg, Sweden
Research Site
Stockholm, Sweden
Research Site
Ängelholm, Sweden
Sponsors and Collaborators
Biogen Idec A/S
Study Director: Medical Director Biogen

Responsible Party: Biogen Identifier: NCT01065090     History of Changes
Other Study ID Numbers: ACTIMS
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: April 2015

Keywords provided by Biogen:
Capacity for Work Questionnaire
SDMT: Symbol Digit Modalities Test
FSMC: Fatigue Scale for Motor and Cognitive functions
effects of exercise
EDSS: Expanded Disability Status Scale

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases