Physical Activity and Fatigue in Early Multiple Sclerosis (MS)

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Interferon beta-1b (Betaseron, BAY86-5046)

• Registration Number: NCT00882453
• Lead Sponsor: Bayer

Brief Summary

The purpose of this observational study is to obtain a survey on physical activity in patients who for the first time have experienced symptoms which indicate a high risk for developing multiple sclerosis (MS) and in patients with recently diagnosed MS, and to obtain information on factors potentially influencing the patients' level of activity.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2009-04-15
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-16
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-28
• Last Update Posted: 2012-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1739

Inclusion Criteria

• Multiple sclerosis diagnosed within the last 12 months
• Clinically isolated Syndrome (CIS), under Interferon-beta-1b treatment

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Interferon beta-1b (Betaseron, BAY86-5046)	-

Primary Outcome Measures

Name	Time	Method
Physical Activity and Fatigue	At baseline and at Month 24

Secondary Outcome Measures

Name	Time	Method
Health-related Quality of Life	At baseline and at Month 24
Depression	At baseline and at Month 24