Clinical trial NCT01065090: A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Participants With Multiple Sclerosis
Official title: A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exercise
Keywords: 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
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Biogen Idec A/S
First posted: 2010-02-09
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on AVONEX 3-6 months after treatment initiation

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Change of muscle strength
timeFrame: Baseline, 12 months, 15 months and 18 months.
Secondary outcomes:
measure: Changes of speed of walking
timeFrame: Baseline, 12 months and 18 months
Other outcomes:
Locations:
city: NSW
country: Australia
facility: Coordinating Research Site
city: Odense
country: Denmark
facility: Research Site
city: Sønderborg
country: Denmark
facility: Research Site
city: Vejle
country: Denmark
facility: Research Site
city: Jyväskylä
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Pori
country: Finland
facility: Research Site
city: Seinäjokï
country: Finland
facility: Research Site
city: Hamilton
country: New Zealand
facility: Research Site
city: Drammen
country: Norway
facility: Research Site
city: Ullevål
country: Norway
facility: Research Site
city: Gothenburg
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Ängelholm
country: Sweden
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: