Project BIPAMS: Behavioral Intervention for Physical Activity in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Change of Physical Activity levels through Accelerometery from baseline at 6 and 12 months.
研究概览
简要总结
This randomized controlled trial will examine the effect of a 6-month behavioral intervention, based on social cognitive theory and delivered through the Internet, for increasing physical activity and secondarily improving mobility, cognition, symptoms and quality of life in persons with MS. The investigators hypothesize that individuals who receive the 6-month behavioral intervention will demonstrate an increase in physical activity behavior that will last throughout a 6-month follow up compared with participants in the control condition. The investigators further hypothesize that individuals in the behavioral intervention will demonstrate better walking mobility and cognitive function, reduced fatigue, depression, anxiety, and pain, and improved quality of life compared to the control condition. The investigators hypothesize that the behavioral intervention will increase physical activity through positive changes in self-efficacy, outcome expectations, goal setting, and impediments as social-cognitive determinants.
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 (Participant)
盲法说明
The investigators will advertise the study as comparing two approaches delivered through the Internet for managing consequences of MS and improving health indicators. On randomization, the investigators will again reaffirm this position with the participant. The participant will not be informed about which condition is the control or the intervention.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MS
- •Relapse free in the past 30 days
- •Internet and email access
- •Willingness to complete the questionnaires, wear the accelerometer, and undergo randomization
- •Being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous six months
- •Ability to ambulate with or without assistance (i.e. walking with or without a can or walker, but not a wheelchair)
- •Age between 18 and 64
排除标准
- •Moderate or high risk for undertaking strenuous or maximal exercise per participants response to the PAR-Q. Those who report no more than one YES or affirmative on the 7 item PAR-Q will be considered at low risk and included for participation. All others will be considered at moderate or high risk and excluded from participation.
研究组 & 干预措施
BIPAMS
The behavioral intervention consists of two primary components, a dedicated Internet website and one-on-one video chats with a behavioral coach via Skype. The behavioral intervention focuses on the skills, techniques, resources, and strategies for becoming and staying physically active with MS, but it does not provide a prescription for exercise or physical activity itself.
干预措施: BIPAMS (Behavioral)
WELLMS
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.
干预措施: WELLMS (Behavioral)
结局指标
主要结局
Change of Physical Activity levels through Accelerometery from baseline at 6 and 12 months.
时间窗: Baseline through 12 months
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, 6 months, and 12 months.
Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire from baseline at 6 and 12 months.
时间窗: Baseline through 12 months.
Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire. Participants will complete this questionnaire at baseline, 6 months, and 12 months.
Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire from baseline at 6 and 12 months.
时间窗: Baseline through 12 months.
Physical activity will be assessed using the Abbreviated International Physical Activity Questionnaire. Participants will complete this questionnaire at baseline, 6 months, and 12 months.
次要结局
- Change of self-report measures of Cognition through the Perceived Deficits Questionnaire from baseline at 6 and 12 months.(Baseline through 12 months)
- Changes of self-report measures of quality of life through the Medical Outcomes Study Short Form-36 at 6 and 12 months from baseline.(Baseline through 12 months)
- Changes of self-report measures of quality of life through the Multiple Sclerosis Impact Scale-29 at 6 and 12 months from baseline.(Baseline through 12 months)
- Change of self-report measures of Cognition through the Multiple Sclerosis Neuropsychological Questionnaire from baseline at 6 and 12 months.(Baseline through 12 months)
- Change of self-report measures of Fatigue through the Modified Fatigue Impact Scale at 6 and 12 months from baseline.(Baseline through 12 months)
- Changes of self-report measures of sleep through the Pittsburgh Sleep Quality Index at 6 and 12 months from baseline.(Baseline through 12 months)
- Change of self-report measures of Pain through the Short-form of McGill Pain Questionnaire at 6 and 12 months from baseline.(Baseline through 12 months)
- Change of self-report measures of Walking through the Patient Determined Disease Steps Scale from baseline at 6 and 12 months.(Baseline through 12 months)
- Change of self-report measures of Fatigue through the Fatigue Severity Scale from baseline at 6 and 12 months.(Baseline through 12 months)
- Change of self-report measures of walking through the Multiple Sclerosis Walking Scale - 12 from baseline at 6 and 12 months(Baseline through 12 months)
- Change of self-report measures of Anxiety and Depression through the Hospital Anxiety and Depression Scale at 6 months and 12 months from baseline.(Baseline through 12 months)
研究者
Donald Lein
Primary Investigator
University of Alabama at Birmingham