Physical Activity Intervention for Improving Vascular Comorbidity Risk in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
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.
干预措施: Lifestyle Physical Activity (Behavioral)
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.
干预措施: General Wellness (Behavioral)
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
Lara Pilutti
Associate Professor
University of Ottawa