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Completed

NCT Number: NCT01122056

Effect of Aerobic Exercise on Side Effects of Disease Modifying Therapy With Subcutaneous Interferon-b1b in Patients With Multiple Sclerosis

The purpose of this study is to investigate the effects and tolerability of exercise on side effects of injectable disease modifying treatments in multiple sclerosis. The investigators main hypothesis is that controlled exercise is safe and can be well tolerated in patients with multiple sclerosis and it can improve disease modifying treatment related side effects such as fatigue.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Motor Activity Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vancouver Coastal Health: University of British Columbia Hospital

Vancouver, British Columbia, Canada

About this study

Patient compliance with disease modifying treatment largely depends on relatively common side effects of such treatments such as fatigue. Regular exercise can potentially improve these side effects. However, Safety and effects of exercise has not been studied in patients with multiple sclerosis. Our main aim is to study the safety, tolerability and effects of exercise on side effects of subcutaneous interferon-b1b in patients with Multiple Sclerosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recent diagnosis of relapsing remitting multiple sclerosis on treatment with b1b-interferon disease modifying treatment

Treatment and study plan

Physical exercise training

Other

Two 2-hours long interactive training to perform safe and efficient aerobic exercise for patients with multiple sclerosis

Other names: Betaseron b1b-interferon, Aerobic exercise

Primary outcomes

  1. Multiple Sclerosis Fatigue

  2. Quality of Life

  3. Injection site visual analog scale (0-10)

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 12, 2010
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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