Multiple SclerosisNCT01074827
Improving Gait in Multiple Sclerosis (MS) - Strength Training or Treadmill Walking?
A study testing Strength training and treadmill training in people with Multiple Sclerosis, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
The objective of this study is to evaluate the effect of strength training for the lower extremities and treadmill training on walking ability in persons with Multiple Sclerosis. The study is a randomized control trial with two groups and the intervention is 8 weeks of intensive strength training or treadmill walking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Strength training and treadmill training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2010to Apr 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Multiple Sclerosis,classified as relapsing remitting,or primary/secondary progressive
- Expanded Disability Status Scale (EDSS)score of ≤ 6
- Reduced walking ability (subjectively experienced)
Who cannot join
- persons with a level of ataxia, clinically assessed, that would affect their ability to perform the training.
- spasticity requiring stretching og treatment with baclofen.
- Other, not MS-related, conditions affecting walking ability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strength Training or Treadmill Walking? A Randomized Control Study on the Effect on Gait in Multiple Sclerosis
The objective of this study is to evaluate the effect of strength training for the lower extremities and treadmill training on walking ability in persons with Multiple Sclerosis. The study is a randomized control trial with two groups and the intervention is 8 weeks of intensive strength training or treadmill walking. Primary outcome measure is walking ability, secondary outcome measures are balance, work economy and strength.
- Conditions
- Multiple Sclerosis
- Being tested
- Strength training and treadmill training
- Keywords
- Multiple Sclerosis, Walking ability, Strength, Balance, Treadmill walking
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training and treadmill trainingOther
Eight weeks of intensive strength training or treadmill training
| Study group | Role | What they receive |
|---|---|---|
| Treadmill group | Experimental | Specific gait training on treadmill Receives: Other: Strength training and treadmill training |
| Strength training group | Experimental | Eight weeks of intensive strength training Receives: Other: Strength training and treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking ability
Measured: 8 weeks
Secondary outcomes (3)
Strength
Measured: 8 weeks
Work economy O2
Measured: 8 weeks
Balance
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Helse Midt-Norge
- Responsible party
- Sponsor
- Investigators
- Siri M, Brændvik, Study chair, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074827
- Sponsor's protocol ID
- 09/225
- Status last verified
- Jul 2015
- First submitted
- 23 Feb 2010
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Braendvik SM, Koret T, Helbostad JL, Loras H, Brathen G, Hovdal HO, Aamot IL. Treadmill Training or Progressive Strength Training to Improve Walking in People with Multiple Sclerosis? A Randomized Parallel Group Trial. Physiother Res Int. 2016 Dec;21(4):228-236. doi: 10.1002/pri.1636. Epub 2015 Jun 25.
PubMed 26110230
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training or Treadmill Walking? A Randomized Control Study on the Effect on Gait in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01074827
- Acronym / sponsor ID
- 09/225
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Walking ability, Strength, Balance, Treadmill walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Helse Midt-Norge
- Study start
- Mar 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 24 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 objective of this study is to evaluate the effect of strength training for the lower extremities and treadmill training on walking ability in persons with Multiple Sclerosis. The study is a randomized control trial with two groups and the intervention is 8 weeks of intensive strength training or treadmill walking. Primary outcome measure is walking ability, secondary outcome measures are balance, work economy and strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill group | Experimental | Other: Strength training and treadmill trainingSpecific gait training on treadmill |
| Strength training group | Experimental | Other: Strength training and treadmill trainingEight weeks of intensive strength training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with Multiple Sclerosis,classified as relapsing remitting,or primary/secondary progressive
- Expanded Disability Status Scale (EDSS)score of ≤ 6
- Reduced walking ability (subjectively experienced)
Key exclusion criteria (3 listed)
- persons with a level of ataxia, clinically assessed, that would affect their ability to perform the training.
- spasticity requiring stretching og treatment with baclofen.
- Other, not MS-related, conditions affecting walking ability.
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 |
|---|---|---|
| Strength training and treadmill trainingEight weeks of intensive strength training or treadmill training | Other | Strength training group, Treadmill group |
Primary outcome
Walking ability
Time frame: 8 weeks
3 secondary outcomes
Strength
Time frame: 8 weeks
Work economy O2
Time frame: 8 weeks
Balance
Time frame: 8 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 8 Jul 2015.
- Results publication: PubMed 26110230Braendvik SM, Koret T, Helbostad JL, Loras H, Brathen G, Hovdal HO, Aamot IL. Treadmill Training or Progressive Strength Training to Improve Walking in People with Multiple Sclerosis? A Randomized Parallel Group Trial. Physiother Res Int. 2016 Dec;21(4):228-236. doi: 10.1002/pri.1636. Epub 2015 Jun 25.
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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.
Siri M, Brændvik study chair
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training and treadmill training in people with Multiple Sclerosis, run by St. Olavs Hospital at 1 site in Norway.
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 3 inclusion and 3 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 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Walking ability (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01074827, which also lists 1 linked publication.
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 8 Jul 2015.