NCT05506202

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

August 16, 2022

Last Update Submit

December 30, 2025

Conditions

Keywords

Basic body awareness therapyChronic obstructive pulmonary diseaseDyspneaSelf-managementPhysiotherapy

Outcome Measures

Primary Outcomes (5)

  • 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

    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

    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.

    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).

    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

    2 months

Study Arms (2)

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.

Other: Individual basic body awareness therapyOther: 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.

Other: Respiratory physiotherapy interventions

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.

Control groupIntervention group

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 group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North District Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist I

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 18, 2022

Study Start

August 1, 2022

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

January 6, 2026

Record last verified: 2025-12

Locations