Back to resultsEffect of Aerobic Exercise on Side Effects of Disease Modifying Therapy With Subcutaneous Interferon-b1b in Patients With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physical exercise training
Sponsored by
About this trial
This is an interventional other trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, b1b-interferon, Fatigue, Exercise
Eligibility Criteria
Inclusion Criteria:
- Recent diagnosis of relapsing remitting multiple sclerosis on treatment with b1b-interferon disease modifying treatment
Sites / Locations
- Vancouver Coastal Health: University of British Columbia Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
A = Active group
B = Control group (Placebo Comparator)
Arm Description
Patients will receive interactive exercise training session from an experienced multiple sclerosis
Patients will receive general advice about benefits/side effects of physical activity in multiple sclerosis.
Outcomes
Primary Outcome Measures
Multiple Sclerosis Fatigue
Quality of Life
Injection site visual analog scale (0-10)
Secondary Outcome Measures
Full Information
NCT ID
NCT01122056
First Posted
May 10, 2010
Last Updated
March 1, 2017
Sponsor
University of British Columbia
Collaborators
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
1. Study Identification
Unique Protocol Identification Number
NCT01122056
Brief Title
Effect of Aerobic Exercise on Side Effects of Disease Modifying Therapy With Subcutaneous Interferon-b1b in Patients With Multiple Sclerosis
Official Title
Effect of Aerobic Exercise on Side Effects of Disease Modifying Therapy With Subcutaneous Interferon-b1b in Patients With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 1, 2012 (Actual)
Study Completion Date
June 1, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, b1b-interferon, Fatigue, Exercise
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A = Active group
Arm Type
Active Comparator
Arm Description
Patients will receive interactive exercise training session from an experienced multiple sclerosis
Arm Title
B = Control group (Placebo Comparator)
Arm Type
No Intervention
Arm Description
Patients will receive general advice about benefits/side effects of physical activity in multiple sclerosis.
Intervention Type
Other
Intervention Name(s)
Physical exercise training
Other Intervention Name(s)
Betaseron b1b-interferon, Aerobic exercise
Intervention Description
Two 2-hours long interactive training to perform safe and efficient aerobic exercise for patients with multiple sclerosis
Primary Outcome Measure Information:
Title
Multiple Sclerosis Fatigue
Title
Quality of Life
Title
Injection site visual analog scale (0-10)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recent diagnosis of relapsing remitting multiple sclerosis on treatment with b1b-interferon disease modifying treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Boyd
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kristen Campbell
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Saul Isserow
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
Vancouver Coastal Health: University of British Columbia Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Effect of Aerobic Exercise on Side Effects of Disease Modifying Therapy With Subcutaneous Interferon-b1b in Patients With Multiple Sclerosis
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