Multiple Sclerosis (Relapsing Remitting)NCT01518660
Multiple Sclerosis and Progressive Resistance Training
A study testing Training in people with Multiple Sclerosis (Relapsing Remitting), run by University of Aarhus at 2 sites in Denmark.
Trial summary
The purpose of this study is to investigate underlying mechanisms possibly explaining the beneficial effects of progressive resistance training for people with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis (Relapsing Remitting)
- What is being tested?
- Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesDenmark
- Study dates
- Feb 2012to Jan 2014
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed relapsing-remitting MS according to the McDonald criteria
- Expanded Disability Status Scale (EDSS) between 2.0 and 5.5
- Be able to train twice a week at the University
- Use interferon based medication
Who cannot join
- Alcohol abuse, Alzheimer's and pacemaker (or other metallic implant)
- Comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases
- Having had an attack in a period of 8 weeks prior to the start of the intervention period
- Having an attack during the intervention period
- Pregnancy
- Systematic resistance training in a period of 3 months prior to the start of the intervention period.
- Training adherence of less than 85%.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
MS Clinic, Department of Neurology, Aarhus University Hospital
Aarhus C, 8000
Sport Science, Aarhus University
Aarhus C, 8000
About this study
Official title: Multiple Sclerosis - Inflammatory, Neurological and Muscular Adaptations to Progressive Resistance Training
The purpose of this study is to investigate underlying mechanisms possibly explaining the beneficial effects of progressive resistance training for people with multiple sclerosis.
Read the detailed description
Exercise in general, and progressive resistance training (PRT) in particular, is regarded as an important tool in the rehabilitation of people with multiple sclerosis (MS).
Previous studies have reported positive effects of PRT on muscle strength, functional capacity, fatigue and quality of life. Also, a possible disease modifying effect has been proposed. However, the underlying physiological mechanisms that might explain these beneficial effects and the possible effects on disease progression are unresolved. Additionally, none of the previous studies has been concerned with the possible impact of MS progression type, gender and/or medication.
The purpose of this randomized, controlled, gender stratified trial is to investigate underlying mechanisms possibly explaining the beneficial effects of progressive resistance training for people with multiple sclerosis.
- Conditions
- Multiple Sclerosis (Relapsing Remitting)
- Being tested
- Training
- Keywords
- Resistance Training, Strength Training
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
Bi-weekly progressive resistance training
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | Not described Receives: Behavioral: Training |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood-borne biomarkers
Resting levels of bloodbourne biomarkers;
- Cytokines
- Neurotrophins
Measured: Change from baseline to 24 weeks
Secondary outcomes (6)
Neuro-muscular function of knee extensors
By use of an isokinetic dynamometer, EMG and stimulation equipment the following will be assessed for the knee extensors;
- Maximal muscle strength
- Surface EMG
- Central activation ratio
Measured: Change from baseline to 24 weeks
Walking performance
Walking performance will be assessed by the;
- Two minute walk test
- 25-foot walk test
- Chair rise test
- Stair climb test
Measured: Change from baseline to 24 weeks
Self-reported measures
The self-reported measures contains questionnaires regarding;
- Fatigue (Fatigue Severity Scale, Modifies Fatigue Impact Scale)
- Health-Related Quality of Life (SF-36)
- Depression (Major Depression Inventory)
- Disease impact (MS Impact Scale 29)
- Walking Performance (MS Walking Scale 12)
Measured: Change from baseline to 24 weeks
Brain volume
MRI-scans of the head will provide the following measurements;
- Brain volume (analysed with SIENA)
- Plaque incidence
Measured: Change from baseline to 24 weeks
Body Composition
Weight and Bodyfat-% will be assessed with a Bodycomposition weight (Tanita SC220)
Measured: Change from baseline to 24 weeks
Thigh muscle cross-sectional area
MRI-scans of the thigh will provide cross-sectional area of
- m. quadriceps
- m. hamstring
Measured: Change from baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startFeb 2012
- 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 Multiple Sclerosis (Relapsing Remitting)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Biogen
- Responsible party
- Sponsor
- Investigators
- Tue Kjølhede, M.Sc., Principal investigator, Sport Science, Department of Public Health, Aarhus UniversityUlrik Dalgas, Ph.D., Study chair, Sport Science, Department of Public Health, Aarhus UniversityKristian Vissing, Ph.D., Study chair, Sport Science, Department of Public Health, Aarhus UniversityThor Petersen, Dr.med, Study chair, MS Clinic, Department of Neurology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518660
- Sponsor's protocol ID
- MS&PRT_SSAU_TK
- Status last verified
- Apr 2013
- First submitted
- 6 Jan 2012
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Sclerosis - Inflammatory, Neurological and Muscular Adaptations to Progressive Resistance Training
- ClinicalTrials.gov ID
- NCT01518660
- Acronym / sponsor ID
- MS&PRT_SSAU_TK
- Conditions
- Multiple Sclerosis (Relapsing Remitting)
- Keywords
- Resistance Training, Strength Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Biogen
- Study start
- Feb 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Jan 2012 (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 purpose of this study is to investigate underlying mechanisms possibly explaining the beneficial effects of progressive resistance training for people with multiple sclerosis.
Detailed description
Exercise in general, and progressive resistance training (PRT) in particular, is regarded as an important tool in the rehabilitation of people with multiple sclerosis (MS).
Previous studies have reported positive effects of PRT on muscle strength, functional capacity, fatigue and quality of life. Also, a possible disease modifying effect has been proposed. However, the underlying physiological mechanisms that might explain these beneficial effects and the possible effects on disease progression are unresolved. Additionally, none of the previous studies has been concerned with the possible impact of MS progression type, gender and/or medication.
The purpose of this randomized, controlled, gender stratified trial is to investigate underlying mechanisms possibly explaining the beneficial effects of progressive resistance training for people with multiple sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Behavioral: Training |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed relapsing-remitting MS according to the McDonald criteria
- Expanded Disability Status Scale (EDSS) between 2.0 and 5.5
- Be able to train twice a week at the University
- Use interferon based medication
Key exclusion criteria (7 listed)
- Alcohol abuse, Alzheimer's and pacemaker (or other metallic implant)
- Comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases
- Having had an attack in a period of 8 weeks prior to the start of the intervention period
- Having an attack during the intervention period
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainingBi-weekly progressive resistance training | Behavioural | Training |
Primary outcome
Blood-borne biomarkers
Time frame: Change from baseline to 24 weeks
Resting levels of bloodbourne biomarkers; * Cytokines * Neurotrophins
6 secondary outcomes
Neuro-muscular function of knee extensors
Time frame: Change from baseline to 24 weeks
Walking performance
Time frame: Change from baseline to 24 weeks
Self-reported measures
Time frame: Change from baseline to 24 weeks
Brain volume
Time frame: Change from baseline to 24 weeks
Body Composition
Time frame: Change from baseline to 24 weeks
Thigh muscle cross-sectional area
Time frame: Change from baseline to 24 weeks
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 2 Dec 2014.
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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.
Tue Kjølhede, M.Sc. principal investigator
Sport Science, Department of Public Health, Aarhus University
Ulrik Dalgas, Ph.D. study chair
Sport Science, Department of Public Health, Aarhus University
Kristian Vissing, Ph.D. study chair
Sport Science, Department of Public Health, Aarhus University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Multiple Sclerosis (Relapsing Remitting), run by University of Aarhus at 2 sites in Denmark.
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 4 inclusion and 7 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 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Blood-borne biomarkers (time frame: Change from baseline to 24 weeks). 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 2 Dec 2014; AzTrials last refreshed its copy on 27 Oct 2026.