Respiratory Function and Walking Capacity in Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774201

Sponsors and Collaborators
University Hospital Orebro
Örebro County Council
Investigators
Principal Investigator: Elisabeth Westerdahl, Phd Department of Physiotherapy, Örebro University Hospital
  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
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 21, 2014