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临床试验/NCT05506202
NCT05506202已完成不适用

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 人开始时间: 2022年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
6 minutes walking test

研究概览

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).

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
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

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

研究组 & 干预措施

Intervention group

Experimental

In intervention group, one extra physiotherapeutic intervention, Basic Body Awareness Therapy (BBAT), will be provided before ending each visit (on top of basic and advanced respiratory physiotherapy interventions as control group). Each BBAT last for 30-45 minutes. Therapist will verbally guide patients to perform twelve simple and soft movements, including lying, sitting, standing, walking and relational movements in a quiet and secured environment. Therapist will allow patients to explore the movement and the experience. Therapist will also guide patients in shifting focus between balance, free breathing and mental awareness Following principles in BBAT, BBAT movements will be selected for patients as home exercises.

干预措施: Individual basic body awareness therapy (Other)

Intervention group

Experimental

In intervention group, one extra physiotherapeutic intervention, Basic Body Awareness Therapy (BBAT), will be provided before ending each visit (on top of basic and advanced respiratory physiotherapy interventions as control group). Each BBAT last for 30-45 minutes. Therapist will verbally guide patients to perform twelve simple and soft movements, including lying, sitting, standing, walking and relational movements in a quiet and secured environment. Therapist will allow patients to explore the movement and the experience. Therapist will also guide patients in shifting focus between balance, free breathing and mental awareness Following principles in BBAT, BBAT movements will be selected for patients as home exercises.

干预措施: Respiratory physiotherapy interventions (Other)

Control group

Active Comparator

Both basic and advanced respiratory physiotherapy interventions, including respiratory muscles training, breathing techniques, bronchial hygiene maintenance, assisting in non-invasive ventilation therapy and oxygen therapy titration, are provided according to assessment findings. There is an eight-week training program for both groups, therapist will provide one home visit per week and continuously for eight weeks for each patient.

干预措施: Respiratory physiotherapy interventions (Other)

结局指标

主要结局

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

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.

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

次要结局

未报告次要终点

研究者

发起方
North District Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mo Kim Chung

Physiotherapist I

North District Hospital

研究点 (1)

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