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Respiratory Function and Walking Capacity in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Respiratory; Disorder, Functional, Impaired, Difficulty Walking

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Breathing exercises

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Self-assessment, Physical endurance, Respiratory function, Fatigue

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Breathing exercises

Control

Arm Description

Daily deep breathing exercises during two month

Control group

Outcomes

Primary Outcome Measures

Respiratory muscle strength

Maximum expiratory pressure

Secondary Outcome Measures

Full Information

NCT ID

NCT01774201

First Posted

January 18, 2013

Last Updated

January 16, 2017

Sponsor

Region Örebro County

Collaborators

Örebro County Council

1. Study Identification

Unique Protocol Identification Number

NCT01774201

Brief Title

Respiratory Function and Walking Capacity in Multiple Sclerosis

Official Title

Respiratory Function and Walking Capacity in Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Region Örebro County

Collaborators

Örebro County Council

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

Presented above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Respiratory; Disorder, Functional, Impaired, Difficulty Walking

Keywords

Multiple sclerosis, Self-assessment, Physical endurance, Respiratory function, Fatigue

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Breathing exercises

Arm Type

Experimental

Arm Description

Daily deep breathing exercises during two month

Arm Title

Control

Arm Type

No Intervention

Arm Description

Control group

Intervention Type

Other

Intervention Name(s)

Breathing exercises

Intervention Description

Breathing exercises with positive expiratory pressure.

Primary Outcome Measure Information:

Title

Respiratory muscle strength

Description

Maximum expiratory pressure

Time Frame

Two months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elisabeth Westerdahl, Phd

Organizational Affiliation

Department of Physiotherapy, Örebro University Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25620034

Citation

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.

Results Reference

result

PubMed Identifier

25782023

Citation

Nilsagard 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.

Results Reference

result

Learn more about this trial

Respiratory Function and Walking Capacity in Multiple Sclerosis

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