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

NCT ID: NCT01122056

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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A = Active group

Patients will receive interactive exercise training session from an experienced multiple sclerosis

Group Type ACTIVE_COMPARATOR

Physical exercise training

Intervention Type OTHER

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

B = Control group (Placebo Comparator)

Patients will receive general advice about benefits/side effects of physical activity in multiple sclerosis.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical exercise training

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

Intervention Type OTHER

Other Intervention Names

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Betaseron b1b-interferon Aerobic exercise

Eligibility Criteria

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Inclusion Criteria

* Recent diagnosis of relapsing remitting multiple sclerosis on treatment with b1b-interferon disease modifying treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

INDUSTRY

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Boyd

Role: STUDY_DIRECTOR

University of British Columbia

Kristen Campbell

Role: STUDY_DIRECTOR

University of British Columbia

Saul Isserow

Role: STUDY_DIRECTOR

University of British Columbia

Locations

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Vancouver Coastal Health: University of British Columbia Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H10-00277

Identifier Type: -

Identifier Source: org_study_id

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