Multiple SclerosisNCT01774201
Respiratory Function and Walking Capacity in Multiple Sclerosis
A study testing Breathing exercises in people with Multiple Sclerosis and Respiratory; Disorder, Functional, Impaired, run by Region Örebro County.
Trial summary
Multiple sclerosis (MS) is a chronic progressive neurological disease. Respiratory dysfunction due to weakness in the respiratory musculature has been described in MS. This leads to increased morbidity and mortality in late stages of the disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis, Respiratory; Disorder, Functional, Impaired, Difficulty Walking
- What is being tested?
- Breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Inhabitant in Orebro county, Sweden, that are diagnosed with MS according to the revised McDonald criteria and registered in the Swedish MS-registry with EDSS (Expanded disability status scale) score in the interval ≥ 3.0 - ≤ 7.0.
- Participants must understand verbal and written information and must be relapse free ≥ 3 months prior to inclusion.
Who cannot join
- Patients with diseases that may have influence on walking ability and respiratory function (other than MS). Such conditions include heart and lung diseases, orthopedic disorders, patients recently subjected to surgery, and non-MS related neurological dysfunction.
About this study
Multiple sclerosis (MS) is a chronic progressive neurological disease. Respiratory dysfunction due to weakness in the respiratory musculature has been described in MS. This leads to increased morbidity and mortality in late stages of the disease. It is possible that respiratory dysfunction influence physical fitness in earlier stages as well. Walking disability and fatigue causes significant impact on health in patients with MS, even in earlier stages.
The hypothesis is that there is a relationship between respiratory function, walking capacity and fatigue and that daily deep breathing exercise during two months will improve respiratory function, walking capacity and fatigue.
Read the detailed description
Presented above.
- Being tested
- Breathing exercises
- Keywords
- Multiple sclerosis, Self-assessment, Physical endurance, Respiratory function, Fatigue
- Medical subject headings
- Multiple Sclerosis, Mobility Limitation, Respiratory Aspiration, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exercisesOther
Breathing exercises with positive expiratory pressure.
| Study group | Role | What they receive |
|---|---|---|
| Breathing exercises | Experimental | Daily deep breathing exercises during two month Receives: Other: Breathing exercises |
| Control | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strength
Maximum expiratory pressure
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro County Council
- Responsible party
- Principal investigator, Anna Wittrin, Region Örebro County
- Investigators
- Elisabeth Westerdahl, Phd, Principal investigator, Department of Physiotherapy, Örebro University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774201
- Sponsor's protocol ID
- OLL-260361
- Status last verified
- Jan 2017
- First submitted
- 18 Jan 2013
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Westerdahl E, Wittrin A, Kanahols M, Gunnarsson M, Nilsagard Y. Deep breathing exercises with positive expiratory pressure in patients with multiple sclerosis - a randomized controlled trial. Clin Respir J. 2016 Nov;10(6):698-706. doi: 10.1111/crj.12272. Epub 2015 Mar 2.
PubMed 25620034Nilsagard Y, Westerdahl E, Wittrin A, Gunnarsson M. Walking Distance as a Predictor of Falls in People With Multiple Sclerosis. Physiother Res Int. 2016 Jun;21(2):102-8. doi: 10.1002/pri.1625. Epub 2015 Mar 17.
PubMed 25782023
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Function and Walking Capacity in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01774201
- Acronym / sponsor ID
- OLL-260361
- Keywords
- Multiple sclerosis, Self-assessment, Physical endurance, Respiratory function, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Örebro County Council
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Jan 2013 (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.
Multiple sclerosis (MS) is a chronic progressive neurological disease. Respiratory dysfunction due to weakness in the respiratory musculature has been described in MS. This leads to increased morbidity and mortality in late stages of the disease. It is possible that respiratory dysfunction influence physical fitness in earlier stages as well. Walking disability and fatigue causes significant impact on health in patients with MS, even in earlier stages.
The hypothesis is that there is a relationship between respiratory function, walking capacity and fatigue and that daily deep breathing exercise during two months will improve respiratory function, walking capacity and fatigue.
Detailed description
Presented above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing exercises | Experimental | Other: Breathing exercisesDaily deep breathing exercises during two month |
| Control | No intervention | –Control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Inhabitant in Orebro county, Sweden, that are diagnosed with MS according to the revised McDonald criteria and registered in the Swedish MS-registry with EDSS (Expanded disability status scale) score in the interval ≥ 3.0 - ≤ 7.0.
- Participants must understand verbal and written information and must be relapse free ≥ 3 months prior to inclusion.
Key exclusion criteria (1 listed)
- Patients with diseases that may have influence on walking ability and respiratory function (other than MS). Such conditions include heart and lung diseases, orthopedic disorders, patients recently subjected to surgery, and non-MS related neurological dysfunction.
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 |
|---|---|---|
| Breathing exercisesBreathing exercises with positive expiratory pressure. | Other | Breathing exercises |
Primary outcome
Respiratory muscle strength
Time frame: Two months
Maximum expiratory pressure
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 18 Jan 2017.
- Results publication: PubMed 25620034Westerdahl E, Wittrin A, Kanahols M, Gunnarsson M, Nilsagard Y. Deep breathing exercises with positive expiratory pressure in patients with multiple sclerosis - a randomized controlled trial. Clin Respir J. 2016 Nov;10(6):698-706. doi: 10.1111/crj.12272. Epub 2015 Mar 2.
- Results publication: PubMed 25782023Nilsagard Y, Westerdahl E, Wittrin A, Gunnarsson M. Walking Distance as a Predictor of Falls in People With Multiple Sclerosis. Physiother Res Int. 2016 Jun;21(2):102-8. doi: 10.1002/pri.1625. Epub 2015 Mar 17.
- Individual participant dataSharing planned: No
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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.
Elisabeth Westerdahl, Phd principal investigator
Department of Physiotherapy, Örebro University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercises in people with Multiple Sclerosis and Respiratory; Disorder, Functional, Impaired, run by Region Örebro County.
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 2 inclusion and 1 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Respiratory muscle strength (time frame: Two months). 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 NCT01774201, which also lists 2 linked publications.
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 18 Jan 2017.