A Randomized Controlled Trial of a Walking Meditation Intervention (iWalk) to Enhance Resilience in Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Connor Davidson Resilience Scale for Adults (CD-RISC 25)
研究概览
简要总结
This study is a randomized controlled trial of the walking meditation intervention (iWalk) program, a multi-component intervention integrating walking meditation, education, and group sessions designed to enhance resilience in individuals with multiple sclerosis (MS).
The objectives are to evaluate:
- Recruitment capability and retention rates,
- Acceptability and adherence to the intervention,
- Feasibility of assessment procedures, and
- Preliminary effects on psychological, physiological, and behavioral outcomes.
详细描述
The iWalk Program is an 8-week, multi-component behavioral intervention integrating mindfulness-based stress reduction and walking meditation to promote resilience and self-regulation in people with MS. The intervention combines weekly educational content, guided walking meditation, and group reflection delivered both in-person and virtually. Participants in the experimental group will attend three one-hour sessions per week (two via Zoom, one in-person) focusing on mindfulness, interoception, emotional regulation, and positive coping.
The waitlist control group will receive usual care during the trial period and will be offered participation after study completion.
Assessments include psychological questionnaires, electroencephalography (EEG), cognitive tasks, balance testing, and physical activity monitoring using Fitbit and Hexoskin wearable sensors. Data analysis includes assessing quantitative and qualitative changes in resilience, stress, mindfulness, mood, interoceptive awareness, quality of life, and physical activity over 8 weeks.
The total study duration is 10 weeks per participant, including baseline and post-intervention assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older,
- •clinical diagnosis of a neurodegenerative disease such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, stroke, etc.,
- •have not practiced meditation regularly (e.g., 10 mins per day) and have never attended any meditation classes or community programs,
- •never received meditation training via coaching/certification/life coaching,
- •have internet access,
- •with no severe cognitive impairment, i.e., have a score of ≥ 21 on Modified Telephonic Interview for Cognitive Status (TICS-M),
- •be able to walk with or without an assistive device (Patient determined Disease Steps score ranged from 0-6),
- •are willing to be randomized to an intervention or a control group,
- •are willing to wear Fitbit (a wrist smart watch) for eight weeks,
- •are individuals who are right-handed according to the Edinburgh Handedness Questionnaire,
- •are willing to participate in all assessments, including in-person testing using electroencephalography (EEG) and cognitive tests, online survey/questionnaires, and online interviews or focus group discussions,
- •are willing to wear a Hexoskin t-shirt, which is a heart rate variability monitor, while doing the assessments in person.
排除标准
- •Participants who cannot speak, read, write, or listen in English.
结局指标
主要结局
Connor Davidson Resilience Scale for Adults (CD-RISC 25)
时间窗: The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
Multiple Sclerosis Resilience Scale (MSRS)
时间窗: The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
Wisconsin Card Sorting Test
时间窗: The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
Sustained Attention to Response Task
时间窗: The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
Stroop Task
时间窗: The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
Symbol Digit Modalities Test
时间窗: The baseline means assessments done two weeks before the intervention start date. Post-intervention assessments will be conducted two weeks after the intervention. Follow-up 1 is 24 weeks from baseline, and follow-up 2 is 48 weeks from baseline.
次要结局
未报告次要终点
研究者
Chung-Yi Chiu
Associate Professor
University of Illinois at Urbana-Champaign