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

NCT02236624 | Completed

• 1 other identifier: Avonex
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Flu-like symptoms assessment

  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.

  Change from baseline to 24 hours.

Secondary Outcomes (1)

• Bloodbourne biomarkers

  Baseline to 24h

Study Arms (1)

Aerobic Exercise

EXPERIMENTAL

Behavioral: Aerobic exercise

Interventions

Aerobic exercise BEHAVIORAL

Aerobic Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• MS-Clinic of Southern Jutland: collaborator
• MS-Clinic Viborg: collaborator
• MS-Clinic Odense: collaborator
• Biogen: collaborator

Study Sites (1)

Sport Science, Department of Public Health, Aarhus University

Aarhus, Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Martin Langeskov-Christensen, MSc

  Sport Science, Department of Public Health, Aarhus University

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 10, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 19, 2016

Record last verified: 2014-07

Locations

DK (1)