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.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Other
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: January 2021
- Behavioral: Lifestyle Physical Activity
- 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.
- Behavioral: General Wellness
- 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.
Arms, Groups and Cohorts
- 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.
- 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.
Clinical Trial Outcome Measures
- Change in Cardiorespiratory Fitness
- Time Frame: Change in cardiorespiratory fitness from baseline at 6- and 12-months
- Peak oxygen consumption (VO2peak) measured using an incremental exercise test and metabolic measurement system for analyzing expired gases
- Change in Blood Pressure
- Time Frame: Change in blood pressure from baseline at 6- and 12-months
- Systolic and diastolic blood pressure following 5-10 min rest
- Change in Body Composition
- Time Frame: Change in body composition from baseline at 6- and 12-months
- Fat and lean soft tissue masses assessed using dual-energy X-ray absorptiometry
- Change in Blood Glucose
- Time Frame: Change in blood glucose from baseline at 6- and 12-months
- Fasting blood glucose measured in venous blood
- Change in Insulin Resistance
- Time Frame: Change in insulin resistance from baseline at 6- and 12-months
- Homeostatic Model Assessment of insulin resistance (HOMA-IR)
- Change in Triglycerides and Cholesterols
- Time Frame: Change in triglycerides and cholesterols from baseline at 6- and 12-months
- Fasting blood triglycerides and cholesterols (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) measured in venous blood
Participating in This Clinical Trial
- 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
- Previous enrollment in lifestyle physical activity behaviour interventions
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Ottawa
- University of Alabama at Birmingham
- Provider of Information About this Clinical Study
- Principal Investigator: Lara Pilutti, Assistant Professor – University of Ottawa
- Overall Official(s)
- Lara Pilutti, PhD, Principal Investigator, University of Ottawa
- Overall Contact(s)
- Lara Pilutti, PhD, (613) 562-5800, email@example.com
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. Review.
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 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.
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.
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.