A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Patients With Multiple Sclerosis - Full Text View

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:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Exercise and Physical Fitness Fatigue Multiple Sclerosis

U.S. FDA Resources

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

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:	June 7, 2012
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
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases

Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013

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