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出境医 / 临床实验 / Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis

Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Lifestyle Physical Activity Behavioral: General Wellness Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis
Actual Study Start Date : July 21, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Lifestyle Physical Activity

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.

 Behavioral: Lifestyle Physical Activity
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.
Active Comparator: General Wellness
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.
 Behavioral: General Wellness
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.
Outcome Measures
Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Blood Pressure [ Time Frame: Change in blood pressure from baseline at 6- and 12-months ]
    Systolic and diastolic blood pressure following 5-10 min rest

  2. Change in Body Composition [ Time Frame: Change in body composition from baseline at 6- and 12-months ]
    Fat and lean soft tissue masses assessed using dual-energy X-ray absorptiometry

  3. Change in Blood Glucose [ Time Frame: Change in blood glucose from baseline at 6- and 12-months ]
    Fasting blood glucose measured in venous blood

  4. Change in Insulin Resistance [ Time Frame: Change in insulin resistance from baseline at 6- and 12-months ]
    Homeostatic Model Assessment of insulin resistance (HOMA-IR)

  5. Change in Triglycerides and Cholesterols [ Time Frame: 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


Other Outcome Measures:
  1. Neurological Function - Expanded Disability Status Scale [ Time Frame: Baseline, 6-months and 12-months ]
    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).

  2. Dietary Intake [ Time Frame: Baseline, 6-months and 12-months ]
    3-day diet log

  3. Change in Physical Activity - assessed by accelerometry [ Time Frame: Change in physical activity from baseline at 6- and 12-months ]
    Minutes per day of moderate-to-vigorous and light physical activity, and sedentary time

  4. Change in Physical Activity - assessed by Godin Leisure-Time Exercise Questionnaire [ Time Frame: Change in physical activity from baseline at 6- and 12-months ]
    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).

  5. Change in Body Circumferences [ Time Frame: Change in body circumferences from baseline at 6- and 12-months ]
    Waist and hip circumferences

  6. Change in Optical Coherence Tomography (OCT) measures [ Time Frame: Change in OCT measures from baseline at 6- and 12-months ]
    Retinal nerve fibre layer thickness will be assessed using OCT


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
Canada, Ontario
University of Ottawa
Ottawa, Ontario, Canada, K1N 6N5
Sponsors and Collaborators
University of Ottawa
University of Alabama at Birmingham
National Multiple Sclerosis Society
Investigators
Layout table for investigator information
Principal Investigator: Lara Pilutti, PhD University of Ottawa
Tracking Information
First Submitted Date  ICMJE May 6, 2019
First Posted Date  ICMJE May 9, 2019
Last Update Posted Date May 6, 2021
Actual Study Start Date  ICMJE July 21, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • Change in Blood Pressure [ Time Frame: 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 [ Time Frame: 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 Blood Glucose [ Time Frame: Change in blood glucose from baseline at 6- and 12-months ]
    Fasting blood glucose measured in venous blood
  • Change in Insulin Resistance [ Time Frame: Change in insulin resistance from baseline at 6- and 12-months ]
    Homeostatic Model Assessment of insulin resistance (HOMA-IR)
  • Change in Triglycerides and Cholesterols [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 8, 2019)
  • Neurological Function - Expanded Disability Status Scale [ Time Frame: Baseline, 6-months and 12-months ]
    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).
  • Dietary Intake [ Time Frame: Baseline, 6-months and 12-months ]
    3-day diet log
  • Change in Physical Activity - assessed by accelerometry [ Time Frame: Change in physical activity from baseline at 6- and 12-months ]
    Minutes per day of moderate-to-vigorous and light physical activity, and sedentary time
  • Change in Physical Activity - assessed by Godin Leisure-Time Exercise Questionnaire [ Time Frame: Change in physical activity from baseline at 6- and 12-months ]
    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).
  • Change in Body Circumferences [ Time Frame: Change in body circumferences from baseline at 6- and 12-months ]
    Waist and hip circumferences
  • Change in Optical Coherence Tomography (OCT) measures [ Time Frame: Change in OCT measures from baseline at 6- and 12-months ]
    Retinal nerve fibre layer thickness will be assessed using OCT
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis
Official Title  ICMJE Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Behavioral: Lifestyle Physical Activity
    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.
  • Behavioral: General Wellness
    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 Arms  ICMJE
  • Experimental: Lifestyle Physical Activity

    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.

    Intervention: Behavioral: Lifestyle Physical Activity
  • Active Comparator: General Wellness
    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.
    Intervention: Behavioral: General Wellness
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. Review.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 8, 2020) 		5
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2019) 		60
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03944538
Other Study ID Numbers  ICMJE H09-17-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lara Pilutti, University of Ottawa
Study Sponsor  ICMJE University of Ottawa
Collaborators  ICMJE
  • University of Alabama at Birmingham
  • National Multiple Sclerosis Society
Investigators  ICMJE
Principal Investigator: Lara Pilutti, PhD University of Ottawa
PRS Account University of Ottawa
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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