A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Participants 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Exercise Behavior Motor Activity

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Coordinating Research Site, NSW, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Change of muscle strength

Time frame: Baseline, 12 months, 15 months and 18 months.

Measured by chair stand test

Secondary outcomes

Changes of speed of walking

Time frame: Baseline, 12 months and 18 months

Measured by 6 min walk test, Symbol Digit Modalities Test (SDMT), Quality of Life (QoL, SF26, physical part) and Multiple Sclerosis Walking Scale (MSWS)

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Collaborators

Biogen Idec A/S

Registry information

Official study title

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

Acronym: ACTIMS

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Feb 9, 2010
Registry last updated: Apr 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed