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Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Lifestyle Physical Activity

General Wellness

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring Exercise, Fitness, Co-morbidity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Ottawa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lifestyle Physical Activity

General Wellness

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Cardiorespiratory Fitness

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

Secondary Outcome Measures

Change in Blood Pressure

Systolic and diastolic blood pressure following 5-10 min rest

Change in Body Composition

Fat and lean soft tissue masses assessed using dual-energy X-ray absorptiometry

Change in Blood Glucose

Fasting blood glucose measured in venous blood

Change in Insulin Resistance

Homeostatic Model Assessment of insulin resistance (HOMA-IR)

Change in Triglycerides and Cholesterols

Fasting blood triglycerides and cholesterols (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) measured in venous blood

Full Information

NCT ID

NCT03944538

First Posted

May 6, 2019

Last Updated

May 25, 2023

Sponsor

University of Ottawa

Collaborators

University of Illinois at Chicago, National Multiple Sclerosis Society

1. Study Identification

Unique Protocol Identification Number

NCT03944538

Brief Title

Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis

Official Title

Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Terminated

Why Stopped

Research restrictions and recruitment challenges due to the COVID-19 pandemic

Study Start Date

July 21, 2019 (Actual)

Primary Completion Date

October 20, 2020 (Actual)

Study Completion Date

October 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Ottawa

Collaborators

University of Illinois at Chicago, National Multiple Sclerosis Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Exercise, Fitness, Co-morbidity

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lifestyle Physical Activity

Arm Type

Experimental

Arm Description

Arm Title

General Wellness

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle Physical Activity

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

General Wellness

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Cardiorespiratory Fitness

Description

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 Outcome Measure Information:

Title

Change in Blood Pressure

Description

Systolic and diastolic blood pressure following 5-10 min rest

Time Frame

Change in blood pressure from baseline at 6- and 12-months

Title

Change in Body Composition

Description

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

Title

Change in Blood Glucose

Description

Fasting blood glucose measured in venous blood

Time Frame

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

Title

Change in Insulin Resistance

Description

Homeostatic Model Assessment of insulin resistance (HOMA-IR)

Time Frame

Change in insulin resistance from baseline at 6- and 12-months

Title

Change in Triglycerides and Cholesterols

Description

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

Other Pre-specified Outcome Measures:

Title

Neurological Function - Expanded Disability Status Scale

Description

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).

Time Frame

Baseline, 6-months and 12-months

Title

Dietary Intake

Description

3-day diet log

Time Frame

Baseline, 6-months and 12-months

Title

Change in Physical Activity - assessed by accelerometry

Description

Minutes per day of moderate-to-vigorous and light physical activity, and sedentary time

Time Frame

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

Title

Change in Physical Activity - assessed by Godin Leisure-Time Exercise Questionnaire

Description

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).

Time Frame

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

Title

Change in Body Circumferences

Description

Waist and hip circumferences

Time Frame

Change in body circumferences from baseline at 6- and 12-months

Title

Change in Optical Coherence Tomography (OCT) measures

Description

Retinal nerve fibre layer thickness will be assessed using OCT

Time Frame

Change in OCT measures from baseline at 6- and 12-months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lara Pilutti, PhD

Organizational Affiliation

University of Ottawa

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Ottawa

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1N 6N5

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26896750

Citation

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.

Results Reference

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PubMed Identifier

21108624

Citation

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.

Results Reference

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PubMed Identifier

24009162

Citation

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.

Results Reference

background

PubMed Identifier

24699237

Citation

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.

Results Reference

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Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis

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