Clinical trial NCT03944538: Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis
Official title: Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Exercise
Fitness
Co-morbidity
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
name: National Multiple Sclerosis Society
First posted: 2019-05-09
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Cardiorespiratory Fitness
timeFrame: Change in cardiorespiratory fitness from baseline at 6- and 12-months
Secondary outcomes:
measure: Change in Blood Pressure
timeFrame: Change in blood pressure from baseline at 6- and 12-months
measure: Change in Body Composition
timeFrame: Change in body composition from baseline at 6- and 12-months
measure: Change in Blood Glucose
timeFrame: Change in blood glucose from baseline at 6- and 12-months
measure: Change in Insulin Resistance
timeFrame: Change in insulin resistance from baseline at 6- and 12-months
measure: Change in Triglycerides and Cholesterols
timeFrame: Change in triglycerides and cholesterols from baseline at 6- and 12-months
Other outcomes:
measure: Neurological Function - Expanded Disability Status Scale
timeFrame: Baseline, 6-months and 12-months
measure: Dietary Intake
timeFrame: Baseline, 6-months and 12-months
measure: Change in Physical Activity - assessed by accelerometry
timeFrame: Change in physical activity from baseline at 6- and 12-months
measure: Change in Physical Activity - assessed by Godin Leisure-Time Exercise Questionnaire
timeFrame: Change in physical activity from baseline at 6- and 12-months
measure: Change in Body Circumferences
timeFrame: Change in body circumferences from baseline at 6- and 12-months
measure: Change in Optical Coherence Tomography (OCT) measures
timeFrame: Change in OCT measures from baseline at 6- and 12-months
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Lara Pilutti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.