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Multiple SclerosisNCT03944538

Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis

A study testing Lifestyle Physical Activity and General Wellness in people with Multiple Sclerosis, run by University of Ottawa at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Lifestyle Physical Activity and General Wellness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteCanada
Study dates
21 Jul 2019to 20 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • Pregnancy
  • Previous enrollment in lifestyle physical activity behaviour interventions

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Ottawa

    Ottawa, Ontario, K1N 6N5

Other trials in Canada

About this study

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.

Being tested
Lifestyle Physical Activity, General Wellness
Keywords
Exercise, Fitness, Co-morbidity
Medical subject headings
Multiple Sclerosis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle Physical ActivityBehavioural

    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 WellnessBehavioural

    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.

Study groups in NCT03944538
Study groupRoleWhat they receive
Lifestyle Physical ActivityExperimentalThe 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.
Receives: Behavioral: Lifestyle Physical Activity
General WellnessActive comparatorThe 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.
Receives: Behavioral: General Wellness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Cardiorespiratory Fitness

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

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

Secondary outcomes (5)

  1. Change in Blood Pressure

    Systolic and diastolic blood pressure following 5-10 min rest

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

  2. Change in Body Composition

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

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

  3. Change in Blood Glucose

    Fasting blood glucose measured in venous blood

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

  4. Change in Insulin Resistance

    Homeostatic Model Assessment of insulin resistance (HOMA-IR)

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

  5. Change in Triglycerides and Cholesterols

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2019
  2. Study start21 Jul 2019
  3. Primary completion20 Oct 2020
  4. Study completion20 Oct 2020

Why it stopped: Research restrictions and recruitment challenges due to the COVID-19 pandemic

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03944538
Sponsor's protocol ID
H09-17-06
Status last verified
May 2023
First submitted
6 May 2019
Last updated
30 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26896750

  • 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.

    PubMed 21108624

  • 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.

    PubMed 24009162

  • 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.

    PubMed 24699237

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle Physical Activity and General Wellness in people with Multiple Sclerosis, run by University of Ottawa at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Research restrictions and recruitment challenges due to the COVID-19 pandemic). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cardiorespiratory Fitness (time frame: Change in cardiorespiratory fitness from baseline at 6- and 12-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03944538, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.

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Clinical Trial NCT03944538 | AzTrials