Effects of a Comprehensive Health Coaching Program on Lung Function, Exercise Tolerance, Symptom Distress, Quality of Life, Readmission, and Survival in Advanced Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from Baseline Lung function at 3 months, 6months
研究概览
简要总结
Chronic obstructive pulmonary disease due to incurable and prevalence has increased steadily, chronic respiratory disease is considered hazardous to health and quality of life of the disease. GOLD treatment guidelines (global initiative for chronic obstructive lung disease guideline) pointed out the pulmonary rehabilitation is one of the non-drug treatment in patients with severe COPD, shown to improve exercise capacity and reduce the short of breathing, improve the quality of life and reduce the anxiety associated and depression and improved survival advantages. Meanwhile, a few studies have examined effect the exercise training in severe COPD patients' symptom distress and quality of life, so as to make severe COPD patients to improve the effectiveness of the campaign to ongoing regular pulmonary rehabilitation movement, is considered an important issue.
It has been proposed that physical activity enhancement or exercise training can be effective in improving symptoms and quality of life in these patients. However, it has not been examined systematically. Therefore, the main purposes of this study are: 1.Prevalence of symptom distress; 2.The physical preferences; 3.The relationship between quality of life and physical activity; 4.Effects of Comprehensive Health coaching exercise training on improving fatigue, sleep disturbances, quality of life, readmission, and survival. In the first year of this study, a descriptive-correlational design will be used and in the second and third years of study, the experimental design and prospective longitudinal study will be undertaken. Instruments include motion sensors, physical activity scale, Physical Activity Preferences, Pittsburgh Sleep Quality of Life Index. Statistical analyses include descriptive statistics, t-test, one-way ANOVA, latent growth modeling, Logistic models, GEE, and survival analysis. Results from this study will provide important implications for improving symptom management and quality of life for sever chronic obstructive pulmonary disease patients.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥40 years and ≦80 years
- •patients with advanced COPD are defined according to the diagnostic criteria for severe (GOLD 3) and very severe (GOLD 4)
- •pulmonologist assess need pulmonary rehabilitation, but not accept any rehabilitation exercise program.
- •pulmonologist assessment the patients with a stable state.
- •awareness, has the ability to read, write, and communication.
- •willing to communicate by phone, and can operate smart phones.
排除标准
- •COPD AE requiring corticosteroids, antibiotics, emergency room visit or hospitalization within the past 3 month.
- •diagnosed mentally or cognitive disorder, such as dementia or unable to cooperate.
- •severe hip, knee disease, can not perform exercise, or with neuromuscular dysfunction, such as limb hemiplegia, no independent walking function or other deterioration due to bone and joint disease.
- •combined with severe heart disease, such as AMI, severe arrhythmia or heart failure.
- •current regular practice of physical activity
研究组 & 干预措施
Experiment
Comprehensive Health Coaching Program
干预措施: Comprehensive Health Coaching Program (Behavioral)
Control
Guideline-based usual care
结局指标
主要结局
Change from Baseline Lung function at 3 months, 6months
时间窗: 3 months, 6months
Spirometry (FEVl % predicted )
Change from Baseline Exercise Tolerance at 3 months, 6months
时间窗: 3 months, 6months
6 Minute walking test
次要结局
- Change from Baseline Health-related quality of life at 3 months, 6months(3 months, 6months)
- Readmission rate Survival(1 year)
- Change from Baseline Quality of Sleep at 3 months, 6months(3 months, 6months)
- Change from Baseline Fatigue at 3 months, 6months(3 months, 6months)
- Change from Baseline Psychological distress at 3 months, 6months(3 months, 6months)
- Change from Baseline Symptom Distress at 3 months, 6months(3 months, 6months)