ExerciseACTIMSNCT01065090
A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Participants With Multiple Sclerosis
An observational study of Exercise, run by Biogen at 14 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Exercise
- How many people
- 38 participants
- Where
- 14 sitesin 6 countries
- Study dates
- Jun 2010to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients on AVONEX 3-6 months after treatment initiation
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
Finland4 sites
Research Site
Jyväskylä
Research Site
Oulu
Research Site
Pori
Research Site
Seinäjokï
Denmark3 sites
Research Site
Odense
Research Site
Sønderborg
Research Site
Vejle
Sweden3 sites
Research Site
Ängelholm
Research Site
Gothenburg
Research Site
Stockholm
About this study
Official title: A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Patients 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.
- 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
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of muscle strength
Measured by chair stand test
Measured: Baseline, 12 months, 15 months and 18 months.
Secondary outcomes (1)
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)
Measured: Baseline, 12 months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biogen Idec A/S
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065090
- Sponsor's protocol ID
- ACTIMS
- Acronym
- ACTIMS
- Status last verified
- Apr 2015
- First submitted
- 8 Feb 2010
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01065090
- Acronym / sponsor ID
- ACTIMS / ACTIMS
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- Biogen Idec A/S
- Study start
- Jun 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients on AVONEX 3-6 months after treatment initiation
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of muscle strength
Time frame: Baseline, 12 months, 15 months and 18 months.
Measured by chair stand test
1 secondary outcome
Changes of speed of walking
Time frame: Baseline, 12 months and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise, run by Biogen at 14 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Finland, Denmark, Sweden, Norway, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of muscle strength (time frame: Baseline, 12 months, 15 months and 18 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2015.