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

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.

Study Overview

• Status: Completed
• Conditions: Exercise

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Australia
  • NSW, Australia
    • Coordinating Research Site
• Denmark
  • Odense, Denmark
    • Research Site
  • Sønderborg, Denmark
    • Research Site
  • Vejle, Denmark
    • Research Site
• Finland
  • Jyväskylä, Finland
    • Research Site
  • Oulu, Finland
    • Research Site
  • Pori, Finland
    • Research Site
  • Seinäjokï, Finland
    • Research Site
• New Zealand
  • Hamilton, New Zealand
    • Research Site
• Norway
  • Drammen, Norway
    • Research Site
  • Ullevål, Norway
    • Research Site
• Sweden
  • Gothenburg, Sweden
    • Research Site
  • Stockholm, Sweden
    • Research Site
  • Ängelholm, Sweden
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients on AVONEX 3-6 months after treatment initiation

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of muscle strength	Measured by chair stand test	Baseline, 12 months, 15 months and 18 months.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biogen
• Collaborators: Biogen Idec A/S

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: February 8, 2010
• First Submitted That Met QC Criteria: February 8, 2010
• First Posted (Estimate): February 9, 2010

Study Record Updates

• Last Update Posted (Estimate): April 13, 2015
• Last Update Submitted That Met QC Criteria: April 9, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: exercise; AVONEX; 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: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: ACTIMS