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Aerobic Exercise and Flu-like Symptoms Following Interferon Beta 1a Injections in Patients With Multiple Sclerosis?

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ClinicalTrials.gov Identifier: NCT02236624
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : April 19, 2016
Sponsor:
Collaborators:
Aarhus University Hospital
MS-Clinic of Southern Jutland
MS-Clinic Viborg
MS-Clinic Odense
Biogen
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE September 8, 2014
First Posted Date  ICMJE September 10, 2014
Last Update Posted Date April 19, 2016
Study Start Date  ICMJE March 2014
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
Flu-like symptoms assessment [ Time Frame: Change from baseline to 24 hours. ]
Comparison of the mean relative change in flu-like symptoms severity from pre-injection to 5 hours post-injection. At 12h and 24h post intervention the participants will further register flu-like symptoms.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
Bloodbourne biomarkers [ Time Frame: Baseline to 24h ]
Bloodbourne biomarkers: Cytokines
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aerobic Exercise and Flu-like Symptoms Following Interferon Beta 1a Injections in Patients With Multiple Sclerosis?
Official Title  ICMJE Can Aerobic Exercise Reduce Flu-like Symptoms Following Interferon Beta 1a Injections in Patients With Multiple Sclerosis?
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 purpose is to evaluate whether or not changes in circulating cytokines provide a mechanism that can explain a potential positive effect.

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 (MS) to initiate therapy. The initiation phase of MS treatment is a critical period that can affect patients' views on the long-term acceptability and the adherence to the therapy, underscoring the need for strategies to reduce treatment-related adverse events such as FLS following IFN-ß injections.

Once-weekly intramuscular IFNß-1a, which has been available since 1996, is indicated for the treatment of patients with relapsing forms of MS to slow the accumulation of physical disability progression and the frequency of clinical exacerbations. Although intramuscular IFNß-1a is generally well tolerated, FLS have been reported in up to 76% of patients receiving this treatment. Consequently, interventions that can reduce FLS after IFNß-1a injection are warranted. One approach to reduce FLS has been dose titration. Titration is the practice of initiating therapy with a lower starting dose and gradually increasing the dose at defined intervals until the full dose is reached. Moreover, a combination of dose titration and pre-treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen in healthy subjects, has been sown to reduce FLS severity by 37-76%. However, not all patients benefit from dose titration and also the effects in MS still have to be determined. Consequently, other types of FLS management after IFNß-1a injection have to be determined.

Interestingly, case reports from both Finland and Denmark suggest that aerobic exercise is able to markedly reduce FLS symptoms in MS patients, but so far no studies have evaluated this. However, from healthy subjects it is known that aerobic exercise is capable of positively influencing the immune system and evidence suggests that the prophylactic effect of exercise may, to some extent, be the induction of an anti-inflammatory environment with each bout of exercise (e.g. via increases in circulating anti-inflammatory cytokines including interleukin (IL)-1 receptor antagonist and IL-10).

The existing evidence is particularly suggestive of an acute effect of aerobic exercise on the circulating cytokine levels, which could be an important mechanism in explaining a potential positive effect of aerobic exercise on FLS.

Consequently, the purpose of the present study is to test the hypothesis that aerobic training can reduce FLS 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Behavioral: Aerobic exercise
Study Arms  ICMJE Experimental: Aerobic Exercise
Intervention: Behavioral: Aerobic exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 8, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02236624
Other Study ID Numbers  ICMJE Avonex
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE
  • Aarhus University Hospital
  • MS-Clinic of Southern Jutland
  • MS-Clinic Viborg
  • MS-Clinic Odense
  • Biogen
Investigators  ICMJE
Principal Investigator: Martin Langeskov-Christensen, MSc Sport Science, Department of Public Health, Aarhus University
Study Chair: Ulrik Dalgas, PhD Sport Science, Department of Public Health, Aarhus University
Study Chair: Egon Stenager, Dr.med. MS-Clinic of Southern Jutland (Sønderborg, Vejle, Esbjerg), Department of Neurology, Sønderborg, Denmark and Institute of Regional Health Services, University of Southern Denmark.
Study Chair: Thor Petersen, Dr.med. MS-Clinic Aarhus, Department of Neurology, Aarhus University Hospital, Denmark
PRS Account University of Aarhus
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP