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

March 1, 2017 updated by: University of British Columbia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vancouver Coastal Health: University of British Columbia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Aerobic exercise
  • Betaseron b1b-interferon
NO_INTERVENTION: B = Control group (Placebo Comparator)
Patients will receive general advice about benefits/side effects of physical activity in multiple sclerosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Quality of Life
Multiple Sclerosis Fatigue
Injection site visual analog scale (0-10)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

May 10, 2010

First Submitted That Met QC Criteria

May 11, 2010

First Posted (ESTIMATE)

May 12, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H10-00277

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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