- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05506202
Basic Body Awareness Therapy (BBAT) for Patients With Chronic Obstructive Pulmonary Disease
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
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kim Chung Mo, MSc
- Phone Number: +85226837822
- Email: Dennis.Mo@link.cuhk.edu.hk
Study Locations
-
-
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Hong Kong, Hong Kong
- Recruiting
- North District Hospital
-
Contact:
- Kim Chung Mo, MSc
- Phone Number: +85226837822
- Email: Denins.Mo@link.cuhk.edu.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
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.
|
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.
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.
|
Active Comparator: Control group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Medical Research Council scale for breathlessness
Time Frame: 2 months
|
mMRC is used to establish patients' baseline functional impairment due to dyspnea
|
2 months
|
Dyspnoea-12 (Chinese version)
Time Frame: 2 months
|
D-12 is used to measure patients' dyspnea severity
|
2 months
|
St. George's Respiratory Questionnaire (Chinese version)
Time Frame: 2 months
|
SGRQ is used to measure patients' health-related quality of life
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2 months
|
COPD Self-Efficacy Scale (CSES) (Chinese version)
Time Frame: 2 months
|
2 months
|
|
6 minutes walking test
Time Frame: 2 months
|
6MWT is used to assess patients' functional capacity
|
2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022.316
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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