Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis

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 Overview

• Status: Terminated
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Lifestyle Physical Activity; Behavioral: General Wellness

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lara Pilutti, PhD; Phone Number: 6927 (613) 562-5800; Email: lpilutti@uottawa.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1N 6N5
      • University of Ottawa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: University of Ottawa
• Collaborators: University of Illinois at Chicago; National Multiple Sclerosis Society
• Investigators: Principal Investigator: Lara Pilutti, PhD, University of Ottawa

Publications and helpful links

General Publications

• 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.
• 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.
• 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 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2019
• Primary Completion (Actual): October 20, 2020
• Study Completion (Actual): October 20, 2020

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Fitness; Co-morbidity
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: H09-17-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No