BIPAMS-Brain:Examining the Neural Effects of a Behavioral Intervention for Physical Activity in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Minutes of moderate to vigorous physical activity - Baseline
研究概览
简要总结
Multiple sclerosis [MS] is a prevalent neurological disease that is the leading cause of irreversible neurological disability among young women and the second leading cause of disability among young men in the United States. This disease results in the progressive loss of walking mobility and substantial worsening of cognition, symptoms, and quality of life over time. There is evidence that physical activity is beneficially associated with aerobic fitness and brain structure and function in persons with MS. Nevertheless, this population is strikingly sedentary and physically inactive. This highlights a vital opportunity to improve aerobic fitness and brain health by developing behavioral interventions that increase physical activity. To that end, this project is a Phase-II randomized control trial for examining the efficacy of a behavioral intervention that is based on social-cognitive theory and delivered through the Internet for increasing physical activity and, secondarily, improving aerobic fitness and brain structure and function 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
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of multiple sclerosis
- •relapse free in the last 30 days
- •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 6 months
- •ambulate without assistance
- •low risk for contraindications for MRI
排除标准
- •moderate or high risk for undertaking strenuous or maximal exercise
结局指标
主要结局
Minutes of moderate to vigorous physical activity - Baseline
时间窗: Assessment will be conducted before the intervention
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
Minutes of moderate to vigorous physical activity - Post intervention
时间窗: Assessment will be conducted immediately after the intervention
Activity monitors are Actigraph accelerometers that participants will wear on an elastic belt around their waist for 7 days. These activity monitors measure how frequently and how much an individual moves.
次要结局
- resting state functional brain connectivity - post intervention(Assessment will be conducted immediately after the intervention)
- cardiorespiratory fitness; oxygen consumption during exercise - baseline(Assessment will be conducted before the intervention)
- distance walked - baseline(Assessment will be conducted before the intervention)
- distance walked - post-intervention(Assessment will be conducted immediately after the intervention)
- information processing speed; cognitive function - baseline(Assessment will be conducted before the intervention)
- volume of subcortical grey matter brain structures - baseline(Assessment will be conducted before the intervention)
- cardiorespiratory fitness; oxygen consumption during exercise - post intervention(Assessment will be conducted immediately after the intervention)
- information processing speed; cognitive function - post intervention(Assessment will be conducted immediately after the intervention)
- resting state functional brain connectivity - baseline(Assessment will be conducted before the intervention)
- volume of subcortical grey matter brain structures - post intervention(Assessment will be conducted immediately after the intervention)
研究者
Robert W Motl
Primary Investigator
University of Alabama at Birmingham