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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 May 2016 |
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Main ID: |
NCT02236624 |
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Date of registration:
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08/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Aerobic Exercise and Flu-like Symptoms Following Interferon Beta 1a Injections in Patients With Multiple Sclerosis?
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Scientific title:
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Can Aerobic Exercise Reduce Flu-like Symptoms Following Interferon Beta 1a Injections in Patients With Multiple Sclerosis? |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02236624 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Egon Stenager, Dr.med. |
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Address:
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Telephone:
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Email:
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Affiliation:
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MS-Clinic of Southern Jutland (Sønderborg, Vejle, Esbjerg), Department of Neurology, Sønderborg, Denmark and Institute of Regional Health Services, University of Southern Denmark. |
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Name:
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Ulrik Dalgas, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sport Science, Department of Public Health, Aarhus University |
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Name:
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Thor Petersen, Dr.med. |
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Address:
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Telephone:
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Email:
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Affiliation:
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MS-Clinic Aarhus, Department of Neurology, Aarhus University Hospital, Denmark |
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Name:
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Martin Langeskov-Christensen, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sport Science, Department of Public Health, Aarhus University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Behavioral: Aerobic exercise
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Primary Outcome(s)
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Flu-like symptoms assessment
[Time Frame: Change from baseline to 24 hours.]
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Secondary Outcome(s)
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Bloodbourne biomarkers
[Time Frame: Baseline to 24h]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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