Aerobic Exercise and Flu-like Symptoms Following Interferon Beta 1a In
Can Aerobic Exercise Reduce Flu-like Symptoms Following Interferon Beta 1a Injections in Patients With Multiple Sclerosis?
What it found
We found no results in the registry or in papers.
This trial finished 10 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Aerobic exercise
What it measured
Main measures
Flu-like symptoms assessment
Change from baseline to 24 hours.
Safety
Other measures (1)
Bloodbourne biomarkers
Baseline to 24h
Blood or spinal fluid markersImmune response
Who could take part
Relapsing MS · 18 and over
Show the full criteria
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 pacemaker.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Mar 2014
Main results due
Feb 2016
Finished
Apr 2016