Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-01-09 @ 1:15 PM
Study NCT ID:
NCT05506202
Status:
UNKNOWN
Last Update Posted:
2022-08-18
First Post:
2022-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Basic Body Awareness Therapy (BBAT) for Patients With Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2022-08-16', 'studyFirstSubmitQcDate': '2022-08-16', 'lastUpdatePostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Medical Research Council scale for breathlessness', 'timeFrame': '2 months', 'description': "mMRC is used to establish patients' baseline functional impairment due to dyspnea"}, {'measure': 'Dyspnoea-12 (Chinese version)', 'timeFrame': '2 months', 'description': "D-12 is used to measure patients' dyspnea severity"}, {'measure': "St. George's Respiratory Questionnaire (Chinese version)", 'timeFrame': '2 months', 'description': "SGRQ is used to measure patients' health-related quality of life"}, {'measure': 'COPD Self-Efficacy Scale (CSES) (Chinese version)', 'timeFrame': '2 months'}, {'measure': '6 minutes walking test', 'timeFrame': '2 months', 'description': "6MWT is used to assess patients' functional capacity"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Basic body awareness therapy', 'Chronic obstructive pulmonary disease', 'Dyspnea', 'Self-management', 'Physiotherapy'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nChronic 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.\n\nBasic 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.\n\nThere 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).\n\nThe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with COPD (ICD-9-CM 496.X) AND\n* Ability to stand independently without aids, AND\n* Subjectively experienced dyspnea, AND\n* Ability to listen, speak, read and understand Chinese.\n\nExclusion Criteria:\n\n* Patients with acute exacerbation of COPD within one-month, OR\n* Patients with medical disorders possibly causing dyspnea (for example asthma, heart failure, etc.), OR\n* Patients with major psychiatric or cognitive disorders, OR\n* Patients refusal'}, 'identificationModule': {'nctId': 'NCT05506202', 'briefTitle': 'Basic Body Awareness Therapy (BBAT) for Patients With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'North District Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2022.316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', '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.', 'interventionNames': ['Other: Individual basic body awareness therapy', 'Other: Respiratory physiotherapy interventions']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', '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.', 'interventionNames': ['Other: Respiratory physiotherapy interventions']}], 'interventions': [{'name': 'Individual basic body awareness therapy', 'type': 'OTHER', '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.', 'armGroupLabels': ['Intervention group']}, {'name': 'Respiratory physiotherapy interventions', 'type': 'OTHER', '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.', 'armGroupLabels': ['Control group', 'Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Kim Chung Mo, MSc', 'role': 'CONTACT', 'email': 'Denins.Mo@link.cuhk.edu.hk', 'phone': '+85226837822'}], 'facility': 'North District Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Kim Chung Mo, MSc', 'role': 'CONTACT', 'email': 'Dennis.Mo@link.cuhk.edu.hk', 'phone': '+85226837822'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North District Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist I', 'investigatorFullName': 'Mo Kim Chung', 'investigatorAffiliation': 'North District Hospital'}}}}