NCT01774201

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable multiple-sclerosis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

2.2 years

First QC Date

January 18, 2013

Last Update Submit

January 16, 2017

Conditions

Multiple SclerosisRespiratory; Disorder, Functional, ImpairedDifficulty Walking

Keywords

Multiple sclerosisSelf-assessmentPhysical enduranceRespiratory functionFatigue

Outcome Measures

Primary Outcomes (1)

  • Respiratory muscle strength

    Maximum expiratory pressure

    Two months

Study Arms (2)

Breathing exercises

EXPERIMENTAL

Daily deep breathing exercises during two month

Other: Breathing exercises

Control

NO INTERVENTION

Control group

Interventions

Breathing exercisesOTHER

Breathing exercises with positive expiratory pressure.

Breathing exercises

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 25620034RESULT

  • 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.

    PMID: 25782023RESULT

MeSH Terms

Conditions

Multiple SclerosisMobility LimitationRespiratory AspirationFatigue

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Elisabeth Westerdahl, Phd

    Department of Physiotherapy, Örebro University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

January 18, 2013

First Posted

January 23, 2013

Study Start

September 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 18, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share