Status:
COMPLETED
Aerobic Exercise and Flu-like Symptoms Following Interferon Beta 1a Injections in Patients With Multiple Sclerosis?
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
MS-Clinic of Southern Jutland
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the present study is to test the hypothesis that aerobic training can reduce flu-like symptoms following interferon beta 1a injections in patients with Multiple Sclerosis. A secondary ...
Detailed Description
Flu-like symptoms (FLS) such as fever, muscle aches, chills, and fatigue are common side effects of interferon beta (IFN-ß) treatment and may affect the willingness of patients with multiple sclerosis...
Eligibility Criteria
Inclusion
- Definite relapsing-remitting MS according to the McDonald criteria
- Treated with IFNß-1a (Avonex®) for at least 6 months
- Frequent experiencing FLS (muscle aches, chills, fatigue, fewer9) in the hours following IFNß-1a injection (self-reporting that this happens 75% or more of the times after injection).
- Female subjects of childbearing potential are required to practice effective contraception during the study and to continue contraception for 30 days after their last dose of study treatment.
- Expected to be able to complete the aerobic exercise intervention
- Willingly to transport themselves to the exercise/testing facility
- Give informed consent
- Age above 18 years
Exclusion
- Have FLS (i.e. muscle aches, chills, fatigue or fewer) or serious infection within a 24h period prior to the screening. Patients having chronic FLS or infection will, therefore, be excluded. This will be tested by patient interview and, if required, further examination
- Have a known history or positive test result for hepatitis B, hepatitis C, or HIV
- Use beta-blockers.
- Have clinically significant abnormality in laboratory or electrocardiogram measures, chronic fatigue syndrome or fibromyalgia, pre-malignant disease, or malignant disease
- Have had allergy shot or desensitization therapy within 1 month of day 1 (randomization) vaccination within 2 weeks of day 1.
- Stop taking IFNß-1a.
- Are pregnant.
- Suffer from dementia, alcohol abuse or have a pacemaker.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02236624
Start Date
March 1 2014
End Date
April 1 2016
Last Update
April 19 2016
Active Locations (1)
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1
Sport Science, Department of Public Health, Aarhus University
Aarhus, Aarhus C, Denmark, 8000