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临床试验/NCT03944538
NCT03944538终止不适用

Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis

University of Ottawa2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
2
主要终点
Change in Cardiorespiratory Fitness

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Pregnancy
  • Previous enrollment in lifestyle physical activity behaviour interventions

结局指标

主要结局

Change in Cardiorespiratory Fitness

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lara Pilutti

Associate Professor

University of Ottawa

研究点 (2)

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