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

This study is currently recruiting participants.
Verified June 2011 by Biogen Idec
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01065090
First received: February 8, 2010
Last updated: June 7, 2012
Last verified: June 2011
History of Changes

February 8, 2010
June 7, 2012
August 2010
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whether the addition of exercise improves functional capacity in MS patients undergoing DMT treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01065090 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Patients With Multiple Sclerosis
A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Patients With Multiple Sclerosis

The trial is a randomized, multi-centre and prospective 6-9 month trial with a 3 and 6 month follow up, which aims to investigate the effects of systematic exercise (resistance training) or modified physiotherapy without resistance training in relapsing remitting MS (RRMS) patients treated with standard DMT over the course of 18 months.
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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
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
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Inclusion Criteria:

  • Age > 18 years and age < 65 years at screening
  • 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

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
Both
18 Years to 64 Years
No
Contact: Sara Berkö Sara.berko@biogenidec.com
Denmark,   Finland,   Norway,   Sweden
 
NCT01065090
ACTIMS
Yes
Ulrik Dalgas, Cand. Scient., PhD, Dep. Sports Science, Dalgas Avenue 4, DK-8000 Aarhus C,University of Aarhus.Denmark
Biogen Idec
Not Provided
Not Provided
Biogen Idec
June 2011

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