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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Biogen Idec.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01065090
First received: February 8, 2010
Last updated: September 12, 2013
Last verified: June 2011
  Purpose

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.


Condition
Exercise

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • whether the addition of exercise improves functional capacity in MS patients undergoing DMT treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: August 2010
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients on AVONEX 3-6 months after treatment initiation

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065090

Contacts
Contact: Sara Berkö Sara.berko@biogenidec.com

Locations
Denmark
Research Site Recruiting
Esbjerg, Denmark
Contact: Esbjerg Sygehus    4579182277    est@ribeamt.dk   
Principal Investigator: Stenager Egon, MD         
Research Site Not yet recruiting
Holstebro, Denmark
Contact: Holstebro Hospital         
Principal Investigator: Tørring Jesper, MD         
Research Site Not yet recruiting
Odense, Denmark
Contact: Odense University Hosp.         
Principal Investigator: Ravnborg Mads, MD         
Research Site Active, not recruiting
Sønderborg, Denmark
Research Site Recruiting
Vejle, Denmark
Contact: Vejle Sygehus    4579405504    est@ribeamt.dk   
Principal Investigator: Stenager Egon, MD         
Finland
Research Site Not yet recruiting
Jyväskylä, Finland
Contact: Keski-Suomen Hosp.         
Principal Investigator: Sarasoja Taneli         
Research Site Not yet recruiting
Oulu, Finland
Contact: Oulu Hospital         
Principal Investigator: Keskinarkaus Irma         
Research Site Not yet recruiting
Pori, Finland
Contact: Satakunnan Hosp.         
Principal Investigator: Seppä Juha-Matti         
Research Site Not yet recruiting
Seinäjokï, Finland
Contact: Seinäjokï Hospital         
Principal Investigator: Kuusisto Hanna         
Norway
Research Site Not yet recruiting
Drammen, Norway
Contact: Buskerud Hospital         
Principal Investigator: Björnå Ingrid         
Research Site Not yet recruiting
Ullevål, Norway
Contact: Ullevål Hospital         
Sweden
Research Site Not yet recruiting
Gothenburg, Sweden
Contact: Sahlgrenaks         
Research Site Not yet recruiting
Stockholm, Sweden
Contact: Karolinska Solna         
Principal Investigator: Andersson Magnus         
Research Site Not yet recruiting
Stockholm, Sweden
Contact: karolinska Huddinge         
Principal Investigator: Hillert Jan         
Research Site Not yet recruiting
Ängelholm, Sweden
Contact: Ängelholm         
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Ulrik Dalgas, Cand. Scient., PhD, Dep. Sports Science, Dalgas Avenue 4, DK-8000 Aarhus C,University of Aarhus.Denmark
ClinicalTrials.gov Identifier: NCT01065090     History of Changes
Other Study ID Numbers: ACTIMS
Study First Received: February 8, 2010
Last Updated: September 12, 2013
Health Authority: Norway: Ethics Committee
Denmark: Ethics Committee
Sweden: Medical Products Agency
Finland: Finnish Medicines Agency

Keywords provided by Biogen Idec:
Capacity for Work Questionnaire
exercise
AVONEX
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
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 29, 2014