Mindful Steps: Coupling Technology and Mind-Body Exercise to Facilitate Physical Activity in Chronic Cardiopulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Change in physical activity
研究概览
简要总结
The goal of this fully-remote randomized controlled trial is to test the efficacy of Mindful Steps in facilitating physical activity compared to usual standard of care among 136 patients with COPD and/or HF. The main question it aims to answer is can this intervention promote physical activity as measured by daily step counts in sedentary patients with COPD and/or HF. Participants will be randomized (1:1 ratio) to receive either the Mindful Steps intervention or usual care for 12 months, with both arms receiving a Walking for Health education booklet.
详细描述
This is a 2-arm parallel remotely delivered RCT. A total of 136 participants with COPD and/or HF will be randomized in a 1:1 ratio to one of 2 arms in a pragmatic design: 1) Mindful Steps multi-modal intervention, or 2) usual care (including an education booklet on walking). Subjects will participate in the intervention for 12 months. Testing will occur at baseline, 3, 6, 12 (end intervention), and 15 months (post-intervention follow up) for all participants. Physical activity as measured by pedometer (i.e., daily step counts) at 12 months is the primary outcome to assess the efficacy of the Mindful Steps intervention. Secondary outcomes include cognitive-behavioral measures that may relate to behavior change in a conceptual model (self-efficacy, intrinsic motivation, mindful awareness/interoception) as well as patient-centered clinical outcomes (HRQL, dyspnea, fatigue, PA engagement, sedentary behavior).
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
- Single (Outcomes Assessor)
盲法说明
Testing will be facilitated by study staff who are blinded to treatment assignment.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of COPD (defined as cigarette smoking history > 10 pack-years, and either a ratio of FEV1 to forced vital capacity < 0.70 or chest CT evidence of emphysema) OR clinical diagnosis of HF syndrome (with left ventricular systolic dysfunction or preserved ejection fraction and New York Heart Association Class 1-3)
- •Medical clearance from provider to participate in an exercise program
- •Have an active email account; access to a computer device (desktop, laptop, tablet, or smartphone that supports the Fitbit app).
排除标准
- •COPD or HF exacerbation in the previous month
- •Inability to ambulate
- •Inability to collect at least 7 of 14 days of baseline step counts
- •Current participation in a cardiac or pulmonary rehabilitation program
研究组 & 干预措施
Mindful Steps
Multi-modal web intervention including: pedometer with individualized step-count goals, motivational and educational content, online community forum, mind-body videos (short themed clips that support walking, plus library of mind-body exercises), online group mind-body exercise classes, star incentive system; educational booklet
干预措施: Mindful Steps (Behavioral)
Usual Care
Pragmatic usual care (standard care through participant's healthcare provider including pharmacological treatment and general advice for physical activity); educational booklet
结局指标
主要结局
Change in physical activity
时间窗: baseline, months 3, 6, 12, and 15
Daily step counts will be measured as an objective proxy for physical activity using FitBit pedometers (FitBit Inspire 3)
次要结局
- Change in self-efficacy(baseline, months 3, 6, 12, and 15)
- Change in intrinsic motivation(baseline, months 3, 6, 12, and 15)
- Change in dyspnea(baseline, months 3, 6, 12, and 15)
- Change in mindful awareness(baseline, months 3, 6, 12 and 15)
- Change in fatigue(baseline, months 3, 6, 12 and 15)
- Change in disease-specific quality-of-life(baseline, months 3, 6, 12, and 15)
- Qualitative inquiry(months 6 and 12)
- Change in exercise engagement(baseline, months 3, 6, 12, and 15)
- Change in sedentary behaviors/time(baseline, months 3, 6, 12, and 15)
研究者
Gloria Y. Yeh
Director of Mind-Body Research, BIDMC General Medicine Division; Associate Professor of Medicine, Harvard Medical School
Beth Israel Deaconess Medical Center