Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Feasibility metric: Process
研究概览
简要总结
This single group pre-post pilot intervention will examine the feasibility and initial effect of a 12-week behavioral intervention, based on the Behavior Change Wheel and Capability-Opportunity-Motivation-Behavior (COM-B) model and remotely delivered through electronic newsletters and online one-on-one video conferencing, for promoting physical activity and secondarily reducing fatigue and quality of life in persons newly diagnosed with MS (diagnosed with MS within the past 2 years). The investigators hypothesize the proposed 12-week intervention will be feasible based on process, resource, management, and scientific outcomes. The investigators further hypothesize that individuals who receive the 12-week intervention will demonstrate an increase in physical activity behavior, particularly daily step counts, and reduce fatigue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old
- •Diagnosed with multiple sclerosis for 2 or fewer years
- •Fully ambulatory
- •No relapse within the last 30 days
- •Non-active (Godin Leisure-Time Exercise Questionnaire - Health Contribution Score < 14)
- •Able to read 14-point font size
- •Internet & video conferencing access
- •Undergoing disease-modifying therapy
排除标准
- •Pregnancy
- •Moderate or high risk for undertaking physical activity (≥ 2 affirmatives on the Physical Activity Readiness Questionnaire)
结局指标
主要结局
Feasibility metric: Process
时间窗: 12 weeks
Process assesses participant recruitment, retention, and adherence i. Recruitment and refusal rates ii. Retention, attrition, and adherence rates to study procedures
Feasibility metric: Management
时间窗: 12 weeks
Management assesses data management.
Feasibility metric: Overall safety
时间窗: 12 weeks
Overall safety will be assessed through the number of adverse events.
Feasibility metric: Resource
时间窗: 12 weeks
We will assess the resources required for the study.
Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire from baseline and 12 weeks
时间窗: 12 weeks
Physical activity will be assessed using the Abbreviated International Physical Activity Questionnaire. Participants will complete this questionnaire at baseline and 12 weeks.
Change of Physical Activity levels through Accelerometry from baseline and 12 weeks
时间窗: 12 weeks
Physical activity will be assessed using an ActiGraph accelerometer. Participants will wear an accelerometer on a belt around their waist during the waking hours of a 7 day period. Participants will complete this at baseline and 12 weeks
Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire from baseline and 12 weeks
时间窗: 12 weeks
Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire. Participants will complete this questionnaire at baseline and 12 weeks.
次要结局
- Changes of self-report measures of quality of life through the Multiple Sclerosis Impact Scale-29 at baseline and 12 weeks(12 weeks)
- Change of self-report measures of Fatigue through the Fatigue Severity Scale from baseline and 12 weeks(12 weeks)
- Formative evaluation(12 weeks)
研究者
Elizabeth Barstow
Faculty Advisor
University of Alabama at Birmingham