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Effects of a Comprehensive Health Coaching Program in Advanced Chronic Obstructive Pulmonary Disease.

2018年4月24日 更新者:Taipei Medical University

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.

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.

研究概览

研究类型

介入性

注册 (预期的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Taipei、台湾
        • 招聘中
        • Taipei Medical Hospital-Shuang Ho Hospital,Ministry of Health and Welfare

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Experiment
Comprehensive Health Coaching Program
Comprehensive Health Coaching Program: included physical activity and motivational interviewing techniques, participants were encouraged to set goals with decision-making, self-management and self-monitor their progress, and received support from researcher.
无干预:Control
Guideline-based usual care

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change from Baseline Lung function at 3 months, 6months
大体时间:3 months, 6months
Spirometry (FEVl % predicted )
3 months, 6months
Change from Baseline Exercise Tolerance at 3 months, 6months
大体时间:3 months, 6months
6 Minute walking test
3 months, 6months

次要结果测量

结果测量
措施说明
大体时间
Change from Baseline Health-related quality of life at 3 months, 6months
大体时间:3 months, 6months
St. George's Respiratory Questionnaire
3 months, 6months
Change from Baseline Fatigue at 3 months, 6months
大体时间:3 months, 6months
Brief Fatigue Inventory Short Form BFI-Taiwan Form
3 months, 6months
Change from Baseline Psychological distress at 3 months, 6months
大体时间:3 months, 6months
Hospital Anxiety and Depression Scale
3 months, 6months
Change from Baseline Symptom Distress at 3 months, 6months
大体时间:3 months, 6months
Taiwanese version of the M. D. Anderson Symptom Inventory
3 months, 6months
Change from Baseline Quality of Sleep at 3 months, 6months
大体时间:3 months, 6months
Taiwanese version of the Pittsburgh Sleep Quality Index
3 months, 6months
Readmission rate Survival
大体时间:1 year
pulmonologists blinded to allocation reviewed admission summaries and information to determine as COPD related readmission or mortality
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年3月1日

初级完成 (预期的)

2020年7月31日

研究完成 (预期的)

2020年7月31日

研究注册日期

首次提交

2018年1月2日

首先提交符合 QC 标准的

2018年1月6日

首次发布 (实际的)

2018年1月12日

研究记录更新

最后更新发布 (实际的)

2018年4月26日

上次提交的符合 QC 标准的更新

2018年4月24日

最后验证

2017年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • N201704032

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Comprehensive Health Coaching Program的临床试验

  • The Institute for Functional Medicine
    Functional Medicine Coaching Academy
    完全的
    促进健康
    美国
3
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