The Physiological and Psychological Effect of Mind-Body Walking Exercise for Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 主要终点
- Change of modified Borg scale for dyspnea level
研究概览
简要总结
Mind-body exercise improves symptom of negative moods, dyspnea and quality of life in chronic diseases, but these improvements for chronic obstructive pulmonary disease (COPD) are unproven. This study aims to examine the effects of dyspnea, exercise capacity, heart rate variability(HRV), anxiety, depression, interoceptive awareness, quality of life(QoL) in patients with COPD across a three-month mind-body exercise program.
详细描述
Chronic obstructive pulmonary disease (COPD) is a progressive disease characterized by airflow limitation, has a high prevalence of morbidity and mortality, and results in negative physical, psychological, and quality of life (QoL) impacts. Patients with COPD typically experience dyspnea, exercise intolerance, autonomic dysfunction, anxiety, depression, and poor QoL. Mind-body intervention with walking, breathing, and mindfulness is beneficial for the health of patients with COPD. However, the result of mind-body walking intervention for patients with COPD is not clear. Thus, this study will evaluate the effects of mind-body walking exercise (MBWE) on the physical psychological wellbeing and QoL of patients with COPD.
This study will be a randomized controlled trial. Data will collect from the pulmonary clinics of a medical center in northern Taiwan. The participants will recruit and randomly assign into the MBWE group or the control group. Participants in the control group will receive their usual care. Participants in the MBWE group will receive not only their usual care but also a MBWE program, consisting of walking, breathing, and mindfulness activities, for 30 min per day, 5 days per week, for 8 weeks. Data will collect at baseline and follow up on week 4 (WK 4), week 8 (WK 8), and week 12 (WK12). The primary outcome is dyspnea using modified Borg scale. The secondary outcomes are dyspnea in daily life using modified Medical Research Council (mMRC), exercise capacity using six minute walk distance (6MWD), Heart rate variability (HRV), anxiety and depression using the Hospital Anxiety and Depression scale (HADS), interoceptive awareness using the Multidimensional Assessment of Interoceptive Awareness- Chinese version (MAIA-C), QoL using COPD Assessment Tes (CAT). The independent t-test and Chi-square test were used to examine the homogeneity of the demographic characteristics of two groups. Generalized estimating equations were used to examine the data from repeated measurements.
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 (Care Provider)
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
- •1.mild to severe COPD
排除标准
- •Patients visited the emergency room or were hospitalized previous month;
- •Long-term oxygen therapy;
- •Atrial fibrillation;
- •Severe cognitive impairment;
- •Great than class II heart failure as defined by the New York Heart Association functional classification in previous six months;
- •Pacemaker were excluded;
- •Received cancer treatment
- •Participated in other exercise trials
研究组 & 干预措施
Mind-Body Walking
breathing, walking and meditation
干预措施: Mind-Body Walking (Behavioral)
Usual care
maintain their daily activity
结局指标
主要结局
Change of modified Borg scale for dyspnea level
时间窗: Baseline and follow up on Week 4, 8, and 12.
The modified Borg scale is a visual tool ranging from 0 (not noticeable) to 10 (maximum dyspnea).
次要结局
- Hospital anxiety and depression scale (HADS) for anxiety and depression(Baseline and follow up on Week 4, 8, and 12.)
- modified Medical Research Council (mMRC) for perception of dyspnea in daily life(Baseline and follow up on Week 4, 8, and 12.)
- COPD assessment test (CAT) for quality of life(Baseline and follow up on Week 4, 8, and 12.)
- Heart rate variability (HRV)(Baseline and follow up on Week 4, 8, and 12.)
- The Chinese version multidimensional assessment of interoceptive awareness (MAIA-C) for interoceptive awareness(Baseline and follow up on Week 4, 8, and 12.)
- Six-minute walk distance for exercise capacity(Baseline and follow up on Week 4, 8, and 12.)