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Research restrictions and recruitment challenges due to the COVID-19 pandemic
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| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
| National Multiple Sclerosis Society | OTHER |
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Vascular comorbidities, such as high cholesterol, obesity, high blood pressure, and diabetes, are common among people with multiple sclerosis (MS), and can negatively impact disease diagnosis, treatment, and progression. Physical inactivity may be one possible reason for this increased risk and may occur through changes in cardiorespiratory fitness (the ability of the body to transport and use oxygen during sustained physical activity). While exercise training is effective for improving fitness, factors such as accessibility to facilities and financial cost may not make it a viable option for most people with MS. An alternative approach for improving fitness is by increasing daily physical activity levels. The research team has developed and tested an Internet-delivered lifestyle physical activity intervention that has been shown to improve physical activity levels among people with MS. This lifestyle intervention is a promising approach for also increasing fitness and managing vascular comorbidity risk in persons with MS. This randomized clinical trial will examine the efficacy of a 6-month lifestyle physical activity intervention on cardiorespiratory fitness and vascular comorbidity risk in persons with MS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Physical Activity | Experimental | 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. |
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| General Wellness | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Physical Activity | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiorespiratory Fitness | Peak oxygen consumption (VO2peak) measured using an incremental exercise test and metabolic measurement system for analyzing expired gases | Change in cardiorespiratory fitness from baseline at 6- and 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Pressure | Systolic and diastolic blood pressure following 5-10 min rest | Change in blood pressure from baseline at 6- and 12-months |
| Change in Body Composition | Fat and lean soft tissue masses assessed using dual-energy X-ray absorptiometry |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological Function - Expanded Disability Status Scale | 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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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lara Pilutti, PhD | University of Ottawa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa | Ottawa | Ontario | K1N 6N5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26896750 | Background | 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. | |
| 21108624 | Background | 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. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| General Wellness | Behavioral | 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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| Change in body composition from baseline at 6- and 12-months |
| Change in Blood Glucose | Fasting blood glucose measured in venous blood | Change in blood glucose from baseline at 6- and 12-months |
| Change in Insulin Resistance | Homeostatic Model Assessment of insulin resistance (HOMA-IR) | Change in insulin resistance from baseline at 6- and 12-months |
| Change in Triglycerides and Cholesterols | Fasting blood triglycerides and cholesterols (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) measured in venous blood | Change in triglycerides and cholesterols from baseline at 6- and 12-months |
| Baseline, 6-months and 12-months |
| Dietary Intake | 3-day diet log | Baseline, 6-months and 12-months |
| Change in Physical Activity - assessed by accelerometry | Minutes per day of moderate-to-vigorous and light physical activity, and sedentary time | Change in physical activity from baseline at 6- and 12-months |
| Change in Physical Activity - assessed by Godin Leisure-Time Exercise Questionnaire | 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). | Change in physical activity from baseline at 6- and 12-months |
| Change in Body Circumferences | Waist and hip circumferences | Change in body circumferences from baseline at 6- and 12-months |
| Change in Optical Coherence Tomography (OCT) measures | Retinal nerve fibre layer thickness will be assessed using OCT | Change in OCT measures from baseline at 6- and 12-months |
| 24009162 | Background | 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. |
| 24699237 | Background | 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |