Skip to main content
Clinical Trials/NCT03944538
NCT03944538
Terminated
Not Applicable

Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis

University of Ottawa1 site in 1 country5 target enrollmentJuly 21, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Ottawa
Enrollment
5
Locations
1
Primary Endpoint
Change in Cardiorespiratory Fitness
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 21, 2019
End Date
October 20, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lara Pilutti

Associate Professor

University of Ottawa

Eligibility 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

Exclusion Criteria

  • Pregnancy
  • Previous enrollment in lifestyle physical activity behaviour interventions

Outcomes

Primary Outcomes

Change in Cardiorespiratory Fitness

Time Frame: 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 Outcomes

  • Change in Blood Glucose(Change in blood glucose from baseline at 6- and 12-months)
  • 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 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)

Study Sites (1)

Loading locations...

Similar Trials