Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis

NCT03944538 | Terminated

• 1 other identifier: H09-17-06
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Exercise; Fitness; Co-morbidity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

• Change 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

Other Outcomes (6)

• Neurological Function - Expanded Disability Status Scale

  Baseline, 6-months and 12-months

• Dietary Intake

  Baseline, 6-months and 12-months

• Change in Physical Activity - assessed by accelerometry

  Change in physical activity from baseline at 6- and 12-months

Study Arms (2)

Lifestyle Physical Activity

EXPERIMENTAL

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

General Wellness

ACTIVE COMPARATOR

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

Interventions

Lifestyle Physical Activity BEHAVIORAL

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.

Lifestyle Physical Activity

General Wellness BEHAVIORAL

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.

General Wellness

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Previous enrollment in lifestyle physical activity behaviour interventions

Sponsors & Collaborators

• University of Ottawa: lead
• University of Illinois at Chicago: collaborator
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

Location

Related Publications (4)

• 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.

  PMID: 26896750 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.

  PMID: 21108624 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.

  PMID: 24009162 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.

  PMID: 24699237 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Lara Pilutti, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 9, 2019
• Study Start: July 21, 2019
• Primary Completion: October 20, 2020
• Study Completion: October 20, 2020
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)