Respiratory Function and Walking Capacity in Multiple Sclerosis
This study is ongoing, but not recruiting participants.
Sponsor:
University Hospital Orebro
Collaborator:
Örebro County Council
Information provided by (Responsible Party):
Anna Wittrin, University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT01774201
First received: January 18, 2013
Last updated: January 22, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Multiple Sclerosis Respiratory; Disorder, Functional, Impaired Difficulty Walking |
Other: Breathing exercises |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Respiratory Function and Walking Capacity in Multiple Sclerosis |
Resource links provided by NLM:
Further study details as provided by University Hospital Orebro:
Primary Outcome Measures:
- Respiratory muscle strength [ Time Frame: Two months ] [ Designated as safety issue: No ]Maximum expiratory pressure
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Breathing exercises
Daily deep breathing exercises during two month
|
Other: Breathing exercises |
|
No Intervention: Control
Control group
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Inhabitant in Örebro 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.
Exclusion Criteria:
- 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Anna Wittrin, Phd, University Hospital Orebro |
| ClinicalTrials.gov Identifier: | NCT01774201 History of Changes |
| Other Study ID Numbers: | OLL-260361 |
| Study First Received: | January 18, 2013 |
| Last Updated: | January 22, 2013 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by University Hospital Orebro:
|
Multiple sclerosis Self-assessment Physical endurance Respiratory function Fatigue |
Additional relevant MeSH terms:
|
Multiple Sclerosis Respiration Disorders Sclerosis Mobility Limitation Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Respiratory Tract Diseases Pathologic Processes Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013