Respiratory Function and Walking Capacity in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01774201
Recruitment Status : Completed
First Posted : January 23, 2013
Last Update Posted : January 18, 2017
Örebro County Council
Information provided by (Responsible Party):
Anna Wittrin, Region Örebro County

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.

Condition or disease Intervention/treatment
Multiple Sclerosis Respiratory; Disorder, Functional, Impaired Difficulty Walking Other: Breathing exercises

Detailed Description:
Presented above.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Respiratory Function and Walking Capacity in Multiple Sclerosis
Study Start Date : September 2012
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Breathing exercises
Daily deep breathing exercises during two month
Other: Breathing exercises
Breathing exercises with positive expiratory pressure.
No Intervention: Control
Control group

Primary Outcome Measures :
  1. Respiratory muscle strength [ Time Frame: Two months ]
    Maximum expiratory pressure

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01774201

Sponsors and Collaborators
Region Örebro County
Örebro County Council
Principal Investigator: Elisabeth Westerdahl, Phd Department of Physiotherapy, Örebro University Hospital

Publications of Results:
Responsible Party: Anna Wittrin, Phd, Region Örebro County Identifier: NCT01774201     History of Changes
Other Study ID Numbers: OLL-260361
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Anna Wittrin, Region Örebro County:
Multiple sclerosis
Physical endurance
Respiratory function

Additional relevant MeSH terms:
Multiple Sclerosis
Mobility Limitation
Respiration Disorders
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
Respiratory Tract Diseases