Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis

University of Ottawa5 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Lifestyle Physical ActivityBEHAVIORAL

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.

General WellnessBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Cardiorespiratory Fitness

Peak oxygen consumption (VO2peak) measured using an incremental exercise test and metabolic measurement system for analyzing expired gases

Time frame: Change in cardiorespiratory fitness from baseline at 6- and 12-months

Secondary Outcomes

Change in Blood Pressure

Systolic and diastolic blood pressure following 5-10 min rest

Time frame: 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

Time frame: Change in body composition from baseline at 6- and 12-months

Change in Blood Glucose

Fasting blood glucose measured in venous blood

Time frame: Change in blood glucose from baseline at 6- and 12-months

Change in Insulin Resistance

Homeostatic Model Assessment of insulin resistance (HOMA-IR)

Time frame: 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

Time frame: Change in triglycerides and cholesterols from baseline at 6- and 12-months