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NCT01122056 Clinical Trial

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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01122056
Other study ID # H10-00277
Secondary ID
Status Completed
Phase N/A
First received May 10, 2010
Last updated March 1, 2017
Start date May 2010
Est. completion date June 1, 2012

Study information
Verified date March 2017
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 128
Est. completion date June 1, 2012
Est. primary completion date June 1, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Physical exercise training
Two 2-hours long interactive training to perform safe and efficient aerobic exercise for patients with multiple sclerosis

Locations
Country Name City State
Canada Vancouver Coastal Health: University of British Columbia Hospital Vancouver British Columbia

Sponsors (2)
Lead Sponsor Collaborator
University of British Columbia Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Multiple Sclerosis Fatigue
Primary Quality of Life
Primary Injection site visual analog scale (0-10)
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