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Basic Body Awareness Therapy (BBAT) for Patients With Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Individual basic body awareness therapy
Respiratory physiotherapy interventions
Sponsored by
North District Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Basic body awareness therapy, Chronic obstructive pulmonary disease, Dyspnea, Self-management, Physiotherapy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North District HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 16, 2022
Last Updated
August 16, 2022
Sponsor
North District Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05506202
Brief Title
Basic Body Awareness Therapy (BBAT) for Patients With Chronic Obstructive Pulmonary Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North District Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Basic body awareness therapy, Chronic obstructive pulmonary disease, Dyspnea, Self-management, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Individual basic body awareness therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Respiratory physiotherapy interventions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Medical Research Council scale for breathlessness
Description
mMRC is used to establish patients' baseline functional impairment due to dyspnea
Time Frame
2 months
Title
Dyspnoea-12 (Chinese version)
Description
D-12 is used to measure patients' dyspnea severity
Time Frame
2 months
Title
St. George's Respiratory Questionnaire (Chinese version)
Description
SGRQ is used to measure patients' health-related quality of life
Time Frame
2 months
Title
COPD Self-Efficacy Scale (CSES) (Chinese version)
Time Frame
2 months
Title
6 minutes walking test
Description
6MWT is used to assess patients' functional capacity
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kim Chung Mo, MSc
Phone
+85226837822
Email
Dennis.Mo@link.cuhk.edu.hk
Facility Information:
Facility Name
North District Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Chung Mo, MSc
Phone
+85226837822
Email
Denins.Mo@link.cuhk.edu.hk

12. IPD Sharing Statement

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Basic Body Awareness Therapy (BBAT) for Patients With Chronic Obstructive Pulmonary Disease

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