Moving Mindfully: A MBSR-Centered Approach to Freezing in Parkinson Disease - Randomized Control Trial
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
- Recruitment of Sample: Number of Participants Recruited
研究概览
简要总结
The investigators will conduct an randomized controlled trial (RCT) among people with Parkinson disease (PD) and freezing of gait (FOG) to evaluate the feasibility of a mindfulness intervention compared to a educational program about FOG. FOG is a severe motor disturbance that prevents people from stepping normally and is associated with anxiety, frustration, sedentary behaviors, poorer quality of life, and falls. Mindfulness-Based Stress Reduction (MBSR) is an evidence-based practice that creates a culture to reduce stress and anxiety by increasing conscious awareness and self-compassion. In this study, the investigators will develop a mindfulness-based walking intervention to address both mental health and mobility challenges that constitute FOG.
详细描述
Conduct pilot randomized clinical trial to evaluate feasibility and acceptability of the standardized Mindfulness Based Walking Therapy (MBWT) program. Using the standardized MBWT protocol devised during earlier aims of this study, the investigators will randomize 24 people with PD+FOG to MBWT or FOG education (i.e., usual care and FOG education), examining feasibility elements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed by a neurologist with idiopathic Parkinson disease;
- •age 50 and older;
- •a score on the Hoehn & Yahr (H&Y) scale between I-IV;
- •history of freezing of gait;
- •able to provide informed consent;
- •experience fear or worry in relation to their freezing of gait;
- •able to walk independently with or without an assistive device for at least five minutes; and
- •stable medication regimen for one month prior to enrollment.
排除标准
- •have evidence of dementia (Montreal Cognitive Assessment (MOCA) - Telephone Version < 13) to ensure understanding of materials;
- •are under consideration for deep brain stimulation surgery within the next six months; neurologic condition other than PD;
- •inability to cooperate with the protocol;
- •language, visual, or hearing barriers to participation; or
- •history of orthopedic or other medical problems that limit ability to participate safely in the intervention.
结局指标
主要结局
Recruitment of Sample: Number of Participants Recruited
时间窗: 14 weeks
The investigators will count the number of participants recruited to determine if the feasibility objective of recruitment is met. The investigators benchmark for recruitment is defined as recruiting a target sample of 24 participants to randomize.
Attendance of Participants: Average Number of Participants at Each Session
时间窗: 14 weeks
The investigators will count the number of enrolled participants who were in attendance at each mindfulness session and report the average percentage of participants that attended each mindfulness session over the course of the study to determine if the feasibility objective of attendance is met. The investigators benchmark for attendance is defined as at least 80% of participants attending each session. The number of sessions was 14, we then counted the number of enrolled participants who attended at each session and then averaged that number across the sessions. The unit of measure represents the average number of participants.
Retention of Participants: Number of Participants Who Attended 80% of the Sessions or More
时间窗: 14 weeks
The investigators will count the number of participants who attended 11 or more of the 14 sessions (80% of the sessions). Benchmark: Retention is defined as at least 80% of participants attending 80% of the sessions.
Adherence: Average Percentage of Hours Participants Practiced Mindfulness at Home
时间窗: 12 weeks
The investigators will ask participants to track the number of hours spent practicing mindfulness at home to determine if the feasibility objective of adherence is met. The investigators benchmark for adherence is as completing 70% of daily home assignment hours. No homework assignments after class 12 (class 13 was the retreat).
次要结局
未报告次要终点
研究者
Gammon M Earhart
Professor
Washington University School of Medicine