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

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec A/S
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01065090
First received: February 8, 2010
Last updated: April 9, 2015
Last verified: April 2015

February 8, 2010
April 9, 2015
June 2010
January 2014   (final data collection date for primary outcome measure)
Change of muscle strength [ Time Frame: Baseline, 12 months, 15 months and 18 months. ] [ Designated as safety issue: No ]
Measured by chair stand test
whether the addition of exercise improves functional capacity in MS patients undergoing DMT treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01065090 on ClinicalTrials.gov Archive Site
Changes of speed of walking [ Time Frame: Baseline, 12 months and 18 months ] [ Designated as safety issue: No ]
Measured by 6 min walk test, Symbol Digit Modalities Test (SDMT), Quality of Life (QoL, SF26, physical part) and Multiple Sclerosis Walking Scale (MSWS)
whether exercise improves fatigue, mood and QoL in MS patients undergoing DMT treatment and has an impact on EDSS, time to first relapse, number of relapse free patients, and immunological factors. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Participants With Multiple Sclerosis
A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Patients With Multiple Sclerosis

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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Patients on AVONEX 3-6 months after treatment initiation

Exercise
Not Provided
  • training
    one group will receive resistance training and one group the normal physiotherapeutic treatment
  • physiotherapy
    one group will receive resistance training and one group the normal physiotherapeutic treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
January 2014
January 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Denmark,   Finland,   New Zealand,   Norway,   Sweden
 
NCT01065090
ACTIMS
Yes
Biogen Idec
Biogen Idec
Biogen Idec A/S
Study Director: Medical Director Biogen Idec
Biogen Idec
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP