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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05506202
Other study ID # 2022.316
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2022
Est. completion date October 31, 2023

Study information

Verified date August 2022
Source North District Hospital
Contact Kim Chung Mo, MSc
Phone +85226837822
Email Dennis.Mo@link.cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date October 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Individual basic body awareness therapy
Basic Body Awareness Therapy (BBAT) is a physiotherapeutic 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.
Respiratory physiotherapy interventions
Comprehensive physical and psycho-social assessment and treatments are included. 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.

Locations

Country Name City State
Hong Kong North District Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
North District Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Medical Research Council scale for breathlessness mMRC is used to establish patients' baseline functional impairment due to dyspnea 2 months
Primary Dyspnoea-12 (Chinese version) D-12 is used to measure patients' dyspnea severity 2 months
Primary St. George's Respiratory Questionnaire (Chinese version) SGRQ is used to measure patients' health-related quality of life 2 months
Primary COPD Self-Efficacy Scale (CSES) (Chinese version) 2 months
Primary 6 minutes walking test 6MWT is used to assess patients' functional capacity 2 months
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