Chronic Obstructive Pulmonary DiseaseNCT05506202
Basic Body Awareness Therapy (BBAT) for Patients With Chronic Obstructive Pulmonary Disease
A study testing Individual basic body awareness therapy and Respiratory physiotherapy interventions in people with Chronic Obstructive Pulmonary Disease, run by North District Hospital at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Individual basic body awareness therapy and Respiratory physiotherapy interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Individual basic body awareness therapy, Respiratory physiotherapy interventions
- Keywords
- Basic body awareness therapy, Chronic obstructive pulmonary disease, Dyspnea, Self-management, Physiotherapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual basic body awareness therapyOther
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 interventionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Individual basic body awareness therapy; Other: Respiratory physiotherapy interventions |
| 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. Receives: Other: Respiratory physiotherapy interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Medical Research Council scale for breathlessness
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
Measured: 2 months
Dyspnoea-12 (Chinese version)
Dyspnoea-12 is used to measure patients' dyspnea severity, scale range, 0-36, with a high score indicating worse dyspnea
Measured: 2 months
St. George's Respiratory Questionnaire (Chinese version)
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.
Measured: 2 months
COPD Self-Efficacy Scale (Chinese version)
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).
Measured: 2 months
6 minutes walking test
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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Aug 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- North District Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mo Kim Chung, North District Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506202
- Sponsor's protocol ID
- 2022.316
- Status last verified
- Dec 2025
- First submitted
- 16 Aug 2022
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05506202
- Acronym / sponsor ID
- 2022.316
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Basic body awareness therapy, Chronic obstructive pulmonary disease, Dyspnea, Self-management, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- North District HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Individual basic body awareness therapy, Other: Respiratory physiotherapy interventionsIn 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. |
| Control group | Active comparator | Other: Respiratory physiotherapy interventionsBoth 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual basic body awareness therapyBasic 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. | Other | Intervention group |
| Respiratory physiotherapy interventionsComprehensive 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. | Other | Control group, Intervention group |
Primary outcome
Modified Medical Research Council scale for breathlessness
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual basic body awareness therapy and Respiratory physiotherapy interventions in people with Chronic Obstructive Pulmonary Disease, run by North District Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Medical Research Council scale for breathlessness (time frame: 2 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.