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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01774201
Other study ID # OLL-260361
Secondary ID
Status Completed
Phase N/A
First received January 18, 2013
Last updated January 16, 2017
Start date September 2012
Est. completion date December 2014

Study information

Verified date January 2017
Source Region Örebro County
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

Presented above.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- 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.

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Breathing exercises
Breathing exercises with positive expiratory pressure.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Region Örebro County Örebro County Council

References & Publications (2)

Nilsagård 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. — View Citation

Westerdahl E, Wittrin A, Kånåhols M, Gunnarsson M, Nilsagård 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory muscle strength Maximum expiratory pressure Two months
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