Multiple Sclerosis
Conditions
Keywords
Exercise, Fitness, Co-morbidity
Brief summary
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.
Interventions
BEHAVIORALLifestyle 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.
BEHAVIORALGeneral 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.
Sponsors
University of Illinois at Chicago
National Multiple Sclerosis Society
University of Ottawa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiorespiratory Fitness | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin Resistance | Change in insulin resistance from baseline at 6- and 12-months | Homeostatic Model Assessment of insulin resistance (HOMA-IR) |
| Change in Triglycerides and Cholesterols | 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 |
| Change in Blood Pressure | 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 | 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 | Change in blood glucose from baseline at 6- and 12-months | Fasting blood glucose measured in venous blood |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Optical Coherence Tomography (OCT) measures | Change in OCT measures from baseline at 6- and 12-months | Retinal nerve fibre layer thickness will be assessed using OCT |
| Neurological Function - Expanded Disability Status Scale | Baseline, 6-months and 12-months | 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). |
| Dietary Intake | Baseline, 6-months and 12-months | 3-day diet log |
| Change in Physical Activity - assessed by accelerometry | Change in physical activity from baseline at 6- and 12-months | Minutes per day of moderate-to-vigorous and light physical activity, and sedentary time |
| Change in Physical Activity - assessed by Godin Leisure-Time Exercise Questionnaire | Change in physical activity from baseline at 6- and 12-months | 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 Body Circumferences | Change in body circumferences from baseline at 6- and 12-months | Waist and hip circumferences |
Countries
Canada
Outcome results
None listed