Physical Activity Intervention for Improving Vascular Comorbidity Risk
Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: Research restrictions and recruitment challenges due to the COVID-19 pandemic
This trial finished 6 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Lifestyle Physical Activity
Compared with
- General Wellness
What it measured
Main measures
Change in Cardiorespiratory Fitness
Change in cardiorespiratory fitness from baseline at 6- and 12-months
Physical function
Other measures (5)
Change in Blood Pressure
Change in blood pressure from baseline at 6- and 12-months
Change in Body Composition
Change in body composition from baseline at 6- and 12-months
Physical functionChange in Blood Glucose
Change in blood glucose from baseline at 6- and 12-months
Change in Insulin Resistance
Change in insulin resistance from baseline at 6- and 12-months
Change in Triglycerides and Cholesterols
Change in triglycerides and cholesterols from baseline at 6- and 12-months
Who could take part
MS (type not specified) · 18 to 65
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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.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.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.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.
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History
Started
Jul 2019
Main results due
Oct 2020
Finished
Oct 2020