Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis

Not Applicable

Terminated

• Conditions: Multiple Sclerosis

• Registration Number: NCT03944538
• Lead Sponsor: University of Ottawa

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-09
• Study Start: 2019-07-21
• Primary Completion: 2020-10-20
• Study Completion: 2020-10-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Cardiorespiratory Fitness	Change in cardiorespiratory fitness from baseline at 6- and 12-months	Peak oxygen consumption (VO2peak) measured using an incremental exercise test and metabolic measurement system for analyzing expired gases

Secondary Outcome Measures

Name	Time	Method
Change in Blood Pressure	Change in blood pressure from baseline at 6- and 12-months	Systolic and diastolic blood pressure following 5-10 min rest
Change in Body Composition	Change in body composition from baseline at 6- and 12-months	Fat and lean soft tissue masses assessed using dual-energy X-ray absorptiometry
Change in Insulin Resistance	Change in insulin resistance from baseline at 6- and 12-months	Homeostatic Model Assessment of insulin resistance (HOMA-IR)
Change in Triglycerides and Cholesterols	Change in triglycerides and cholesterols from baseline at 6- and 12-months	Fasting blood triglycerides and cholesterols (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) measured in venous blood
Change in Blood Glucose	Change in blood glucose from baseline at 6- and 12-months	Fasting blood glucose measured in venous blood

Trial Locations

Locations (1)

University of Ottawa; 🇨🇦 Ottawa, Ontario, Canada