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

August 16, 2022 updated by: Mo Kim Chung, North District Hospital

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

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

October 31, 2023

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (Actual)

August 18, 2022

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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