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临床试验/NCT05506202
NCT05506202
已完成
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Individual Basic Body Awareness Therapy (BBAT) as an add-on Treatment for Dyspnea Self-management in Patients With Chronic Obstructive Pulmonary Disease (COPD) - a Quantitative and Qualitative Study

North District Hospital1 个研究点 分布在 1 个国家目标入组 25 人2022年8月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Chronic Obstructive Pulmonary Disease
发起方
North District Hospital
入组人数
25
试验地点
1
主要终点
Modified Medical Research Council scale for breathlessness
状态
已完成
最后更新
3个月前

概览

简要总结

Chronic obstructive pulmonary disease (COPD) is a burden to health care and economic systems globally, to manage this preventable and treatable disease, different pharmacological and non-pharmacological interventions were shown to be effective.

Chronic and progressive dyspnea, cough and sputum production are the characteristic symptoms of COPD. The most commonly encountered symptom in patients with COPD is dyspnea, it is a subjective experience of breathing discomfort . It causes impact on patient's health status, sleep quality, anxiety and depression level. Therefore, skills transfer in self-managing major symptoms are crucial to prevent negative consequences, and as suggested by Global Initiative for Chronic Obstructive Lung Disease (GOLD), managing symptoms and to prevent future risk of exacerbations is important for stable COPD cases.

Basic Body Awareness Therapy (BBAT) is a physio-therapeutic intervention directed toward patients' functional movement quality. The development of BBAT was based on the hypothesis of persons' lacking contact with and lacking awareness on their own body, with their inner life, external environment and in the relation to other persons. Thus, it leads to dysfunctional movement, pain and other body functions. BBAT focus on multi-perspective within a person including physical, physiological, psycho-social-cultural and existential perspectives. It directs patients to be "aware", guides patients to have mental contact with their body, monitors internal sensations and external environment, and thus, to enhance the self-regulated behavior and positive emotional state.

There are three key components in practicing BBAT, namely balance, free breathing and mental awareness. Evidence shown that the effect of BBAT is significant in improving physical and psycho-social well-being in patients with different physical and mental disorders. Now, there is absence of evidence in applying BBAT in managing cases with respiratory diseases, especially for those with prominent symptoms of dyspnea (for example COPD cases).

The objectives of this study are (1) to evaluate individual BBAT as an add-on treatment in patients with COPD, (2) to understand COPD patients' experience through participating in individual Basic Body Awareness Therapy (BBAT).

注册库
clinicaltrials.gov
开始日期
2022年8月1日
结束日期
2023年7月31日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
North District Hospital
责任方
Principal Investigator
主要研究者

Mo Kim Chung

Physiotherapist I

North District Hospital

入排标准

入选标准

  • Patients diagnosed with COPD (ICD-9-CM 496.X) AND
  • Ability to stand independently without aids, AND
  • Subjectively experienced dyspnea, AND
  • Ability to listen, speak, read and understand Chinese.

排除标准

  • Patients with acute exacerbation of COPD within one-month, OR
  • Patients with medical disorders possibly causing dyspnea (for example asthma, heart failure, etc.), OR
  • Patients with major psychiatric or cognitive disorders, OR
  • Patients refusal

结局指标

主要结局

Modified Medical Research Council scale for breathlessness

时间窗: 2 months

mMRC is used to establish patients' baseline functional impairment due to dyspnea, scale from 0 to 4, with 0 indicates only get breathless with strenuous exercise, and 4 indicates too breathless to leave the house or I am breathless when dressing/undressing

Dyspnoea-12 (Chinese version)

时间窗: 2 months

Dyspnoea-12 is used to measure patients' dyspnea severity, scale range, 0-36, with a high score indicating worse dyspnea

St. George's Respiratory Questionnaire (Chinese version)

时间窗: 2 months

St. George's Respiratory Questionnaire is used to measure patients' health-related quality of life, Scores range from 0 to 100, with higher scores indicating more limitations.

COPD Self-Efficacy Scale (Chinese version)

时间窗: 2 months

COPD Self-Efficacy Scale contains 34 items, each item rated by Likert 5-level score ranges from 1 point (completely unconfident) to 5 points (completely confident).

6 minutes walking test

时间窗: 2 months

6 minutes walking test is used to assess patients' functional capacity, the outcome is measuring distance covered and counts in meters, with higher meters covered indicates a better functional capacity

研究点 (1)

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