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

Exercise Clinical Trial

— ACTIMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065090
• Other study ID #: ACTIMS
• Status: Completed
• Phase: N/A
• First received: February 8, 2010
• Last updated: April 9, 2015
• Start date: June 2010
• Est. completion date: January 2014

Study information

• Verified date: April 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics CommitteeDenmark: Ethics CommitteeSweden: Medical Products AgencyFinland: Finnish Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Exercise
• Multiple Sclerosis

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Biogen Idec A/S

Countries where clinical trial is conducted

Australia,  Denmark,  Finland,  New Zealand,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of muscle strength	Measured by chair stand test	Baseline, 12 months, 15 months and 18 months.	No
Secondary	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	No