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
ClinicalTrials.gov Identifier:
NCT01065090
First received: February 8, 2010
Last updated: April 9, 2015
Last verified: April 2015
  Purpose

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
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:

Primary Outcome Measures:
  • Change of muscle strength [ Time Frame: Baseline, 12 months, 15 months and 18 months. ] [ Designated as safety issue: No ]
    Measured by chair stand test


Secondary Outcome Measures:
  • 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)


Enrollment: 38
Study Start Date: June 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
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

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.

  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

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

No publications provided

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01065090     History of Changes
Other Study ID Numbers: ACTIMS
Study First Received: February 8, 2010
Last Updated: April 9, 2015
Health Authority: Norway: Ethics Committee
Denmark: Ethics Committee
Sweden: Medical Products Agency
Finland: Finnish Medicines Agency

Keywords provided by Biogen:
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 July 28, 2015