Aerobic Exercise and Flu-like Symptoms Following Interferon Beta 1a Injections in Patients With M… (NCT02236624) | Clinical Trial Compass
CompletedNot Applicable
Aerobic Exercise and Flu-like Symptoms Following Interferon Beta 1a Injections in Patients With Multiple Sclerosis?
Denmark20 participantsStarted 2014-03
Plain-language 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 purpose is to evaluate whether or not changes in circulating cytokines provide a mechanism that can explain a potential positive effect.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 pacema…