- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03944538
Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lara Pilutti, PhD
- Phone Number: 6927 (613) 562-5800
- Email: lpilutti@uottawa.ca
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1N 6N5
- University of Ottawa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of multiple sclerosis
- Relapse-free in the past 30 days
- Stable course of disease modifying therapy over the past 6 months
- Being non-active, defined as not engaging in regular exercise (i.e., ≥30 minutes/day on >2 days/week during the last 6 months)
- Internet access
- Ability to comprehend study materials and communicate in English
- Expanded Disability Status Scale (EDSS) score <6.0
- Willingness to complete three testing sessions at the University of Ottawa separated by 6 months
- Willing to undergo randomization to a lifestyle physical activity condition or general wellness condition for 6 months
- Intermediate risk level for cardiovascular disease based on the Framingham Cardiovascular Disease Risk Score calculator
- Asymptomatic (i.e., no major signs or symptoms of acute or uncontrolled cardiovascular, metabolic, or renal disease; e.g., chest pain) based on the Get Active Questionnaire and the health history section of the American Heart Association (AHA)/American College of Sports Medicine (ACSM) Health/Fitness Facility Pre-participation Screening Questionnaire
- Physician approval for participation
Exclusion Criteria:
- Pregnancy
- Previous enrollment in lifestyle physical activity behaviour interventions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle Physical Activity
The primary content of the website will be delivered through interactive video courses. The courses will be released seven times during the first two months, four times during the second two months, and twice during the final two months of the intervention. The website Tracker feature will allow for tracking of daily step counts as well as setting goals and monitoring progress. The one-on-one video chats will be conducted face to face through Zoom and will be semi-scripted. The chats will consist of an ongoing review of goal-setting and progress toward goal attainment through Tracker as well as discussion of strategies and facilitators of behavioral changes based on social cognitive theory and current website content. The chats will occur at the same frequency as the video course release. For the second 6 months of the study, participants will be asked to maintain their usual activities. |
The intervention consists of two primary components: a dedicated Internet website and one-on-one video chats with a behavioral coach via Zoom.
The intervention focuses on the skills, techniques, resources and strategies for becoming and staying physically active with MS, but does not provide a prescription for exercise or physical activity itself.
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Active Comparator: General Wellness
The general wellness condition will focus on self-managing MS through means other than physical activity.
The materials are transformations of brochures provided by the National Multiple Sclerosis Society.
The delivery of the Internet materials and chat sessions will occur on the same schedule and frequency as the intervention condition, and will have a comparable time commitment.
This condition will account for attention and social contact as well as other possible biases such as initial reactivity and time spent on the website and video chats.
For the second 6 months of the study, participants will be asked to maintain their usual activities.
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The control condition provides an Internet website and one-on-one video chats that discuss materials about self-managing MS consequences and health indicators through methods other than physical activity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cardiorespiratory Fitness
Time Frame: Change in cardiorespiratory fitness from baseline at 6- and 12-months
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Peak oxygen consumption (VO2peak) measured using an incremental exercise test and metabolic measurement system for analyzing expired gases
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Change in cardiorespiratory fitness from baseline at 6- and 12-months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Blood Pressure
Time Frame: Change in blood pressure from baseline at 6- and 12-months
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Systolic and diastolic blood pressure following 5-10 min rest
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Change in blood pressure from baseline at 6- and 12-months
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Change in Body Composition
Time Frame: Change in body composition from baseline at 6- and 12-months
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Fat and lean soft tissue masses assessed using dual-energy X-ray absorptiometry
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Change in body composition from baseline at 6- and 12-months
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Change in Blood Glucose
Time Frame: Change in blood glucose from baseline at 6- and 12-months
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Fasting blood glucose measured in venous blood
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Change in blood glucose from baseline at 6- and 12-months
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Change in Insulin Resistance
Time Frame: Change in insulin resistance from baseline at 6- and 12-months
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Homeostatic Model Assessment of insulin resistance (HOMA-IR)
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Change in insulin resistance from baseline at 6- and 12-months
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Change in Triglycerides and Cholesterols
Time Frame: Change in triglycerides and cholesterols from baseline at 6- and 12-months
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Fasting blood triglycerides and cholesterols (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) measured in venous blood
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Change in triglycerides and cholesterols from baseline at 6- and 12-months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurological Function - Expanded Disability Status Scale
Time Frame: Baseline, 6-months and 12-months
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The Expanded Disability Status Scale is a standard neurological examination for persons with MS.
The scale is used to assess neurological function within eight functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other.
The total score generated for each participant ranges between 0 (normal neurological function) to 10 (death due to MS).
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Baseline, 6-months and 12-months
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Dietary Intake
Time Frame: Baseline, 6-months and 12-months
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3-day diet log
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Baseline, 6-months and 12-months
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Change in Physical Activity - assessed by accelerometry
Time Frame: Change in physical activity from baseline at 6- and 12-months
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Minutes per day of moderate-to-vigorous and light physical activity, and sedentary time
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Change in physical activity from baseline at 6- and 12-months
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Change in Physical Activity - assessed by Godin Leisure-Time Exercise Questionnaire
Time Frame: Change in physical activity from baseline at 6- and 12-months
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The Godin Leisure-Time Exercise Questionnaire includes three items that measure the frequency of vigorous, moderate, and light physical activities that occur for at least 15 minutes during one's leisure-time over the previous 7 days.
The three items are weighted and then summed into a total score that can range between 0 (low active) to 119 (high active).
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Change in physical activity from baseline at 6- and 12-months
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Change in Body Circumferences
Time Frame: Change in body circumferences from baseline at 6- and 12-months
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Waist and hip circumferences
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Change in body circumferences from baseline at 6- and 12-months
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Change in Optical Coherence Tomography (OCT) measures
Time Frame: Change in OCT measures from baseline at 6- and 12-months
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Retinal nerve fibre layer thickness will be assessed using OCT
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Change in OCT measures from baseline at 6- and 12-months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lara Pilutti, PhD, University of Ottawa
Publications and helpful links
General Publications
- Pilutti LA, Dlugonski D, Sandroff BM, Klaren R, Motl RW. Randomized controlled trial of a behavioral intervention targeting symptoms and physical activity in multiple sclerosis. Mult Scler. 2014 Apr;20(5):594-601. doi: 10.1177/1352458513503391. Epub 2013 Sep 5.
- Platta ME, Ensari I, Motl RW, Pilutti LA. Effect of Exercise Training on Fitness in Multiple Sclerosis: A Meta-Analysis. Arch Phys Med Rehabil. 2016 Sep;97(9):1564-1572. doi: 10.1016/j.apmr.2016.01.023. Epub 2016 Feb 16.
- Motl RW, Goldman M. Physical inactivity, neurological disability, and cardiorespiratory fitness in multiple sclerosis. Acta Neurol Scand. 2011 Feb;123(2):98-104. doi: 10.1111/j.1600-0404.2010.01361.x.
- Pilutti LA, Dlugonski D, Sandroff BM, Klaren RE, Motl RW. Internet-delivered lifestyle physical activity intervention improves body composition in multiple sclerosis: preliminary evidence from a randomized controlled trial. Arch Phys Med Rehabil. 2014 Jul;95(7):1283-8. doi: 10.1016/j.apmr.2014.03.015. Epub 2014 Mar 31.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H09-17-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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