Effect of Aerobic Exercise on Side Effects of Disease Modifying Therapy With Subcutaneous Interferon-b1b in Patients With Multiple Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01122056
First received: May 10, 2010
Last updated: February 15, 2011
Last verified: February 2011
  Purpose

The purpose of this study is to investigate the effects and tolerability of exercise on side effects of injectable disease modifying treatments in multiple sclerosis. The investigators main hypothesis is that controlled exercise is safe and can be well tolerated in patients with multiple sclerosis and it can improve disease modifying treatment related side effects such as fatigue.


Condition Intervention
Multiple Sclerosis
Other: Physical exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: Effect of Aerobic Exercise on Side Effects of Disease Modifying Therapy With Subcutaneous Interferon-b1b in Patients With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Multiple Sclerosis Fatigue
  • Quality of Life
  • Injection site visual analog scale (0-10)

Estimated Enrollment: 128
Study Start Date: May 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A = Active group
Patients will receive interactive exercise training session from an experienced multiple sclerosis
Other: Physical exercise training
Two 2-hours long interactive training to perform safe and efficient aerobic exercise for patients with multiple sclerosis
Other Names:
  • Betaseron b1b-interferon
  • Aerobic exercise
No Intervention: B = Control group (Placebo Comparator)
Patients will receive general advice about benefits/side effects of physical activity in multiple sclerosis.

Detailed Description:

Patient compliance with disease modifying treatment largely depends on relatively common side effects of such treatments such as fatigue. Regular exercise can potentially improve these side effects. However, Safety and effects of exercise has not been studied in patients with multiple sclerosis. Our main aim is to study the safety, tolerability and effects of exercise on side effects of subcutaneous interferon-b1b in patients with Multiple Sclerosis.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recent diagnosis of relapsing remitting multiple sclerosis on treatment with b1b-interferon disease modifying treatment
  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: NCT01122056

Contacts
Contact: Reza Sadjadi, MD rsadjadi@brain.ubc.ca

Locations
Canada, British Columbia
Vancouver Coastal Health: University of British Columbia Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Reza Sadjadi, MD       rsadjadi@brain.ubc.ca   
Sponsors and Collaborators
University of British Columbia
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Investigators
Study Director: Laura Boyd University of British Columbia
Study Director: Kristen Campbell University of British Columbia
Study Director: Saul Isserow University of British Columbia
  More Information

No publications provided

Responsible Party: Dr Anthony Traboulsee, University of British Columbia - Vancouver Coastal Health Research Institute
ClinicalTrials.gov Identifier: NCT01122056     History of Changes
Other Study ID Numbers: H10-00277
Study First Received: May 10, 2010
Last Updated: February 15, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Multiple Sclerosis
b1b-interferon
Fatigue
Exercise

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferons
Interferon-beta
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014