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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01065090




Registration number
NCT01065090
Ethics application status
Date submitted
8/02/2010
Date registered
9/02/2010
Date last updated
13/04/2015

Titles & IDs
Public title
A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Participants With Multiple Sclerosis
Scientific title
A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Patients With Multiple Sclerosis
Secondary ID [1] 0 0
ACTIMS
Universal Trial Number (UTN)
Trial acronym
ACTIMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change of muscle strength - Measured by chair stand test
Timepoint [1] 0 0
Baseline, 12 months, 15 months and 18 months.
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
Baseline, 12 months and 18 months

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Coordinating Research Site - NSW
Recruitment postcode(s) [1] 0 0
- NSW
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Odense
Country [2] 0 0
Denmark
State/province [2] 0 0
Sønderborg
Country [3] 0 0
Denmark
State/province [3] 0 0
Vejle
Country [4] 0 0
Finland
State/province [4] 0 0
Jyväskylä
Country [5] 0 0
Finland
State/province [5] 0 0
Oulu
Country [6] 0 0
Finland
State/province [6] 0 0
Pori
Country [7] 0 0
Finland
State/province [7] 0 0
Seinäjokï
Country [8] 0 0
New Zealand
State/province [8] 0 0
Hamilton
Country [9] 0 0
Norway
State/province [9] 0 0
Drammen
Country [10] 0 0
Norway
State/province [10] 0 0
Ullevål
Country [11] 0 0
Sweden
State/province [11] 0 0
Gothenburg
Country [12] 0 0
Sweden
State/province [12] 0 0
Stockholm
Country [13] 0 0
Sweden
State/province [13] 0 0
Ängelholm

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Biogen Idec A/S
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01065090
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications