Ignite Creation Date:
2025-12-24 @ 12:40 PM
Ignite Modification Date:
2025-12-29 @ 9:09 PM
Study NCT ID:
NCT04913961
Status:
UNKNOWN
Last Update Posted:
2022-01-04
First Post:
2021-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supine Daoyin in the Treatment of AECOPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-03', 'studyFirstSubmitDate': '2021-04-26', 'studyFirstSubmitQcDate': '2021-06-03', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospital stay due to acute exacerbation', 'timeFrame': 'through study completion, an average of 2 weeks', 'description': 'The time from hospitalization to discharge was counted'}, {'measure': 'Clinical symptom assessment questionnaire (CCQ)', 'timeFrame': 'Change from baseline CCQ scores at day 3，day 7，day 14', 'description': 'The Clinical symptom assessment questionnaire (CCQ) is a self-administered questionnaire that measures health-related quality of life. It is an 10-item questionnaire on a 0-6 point scale with higher values indicating greater impact of COPD.'}], 'secondaryOutcomes': [{'measure': 'Activities of daily living (Barthel index)', 'timeFrame': 'Change from baseline Barthel index scores at day 3，day 7，day 14', 'description': 'Activities of daily living (ADL): the scale includes 10 items, including 8 items of self-care activities and 2 items of action related activities, with a total score of 100.'}, {'measure': 'Borg dyspnea score', 'timeFrame': 'Change from baseline Borg dyspnea score at day 3，day 7，day 14', 'description': 'Borg dyspnea score is is a 10-point (0-10) scale based on the severity of dyspnoea. "0" means no dyspnea perception, "10" means most severe dyspnea perception.'}, {'measure': '30-second sit-to-stand test', 'timeFrame': 'Change from baseline 30-second sit-to-stand test at day 3，day 7，day 14', 'description': 'Record the times of sitting and standing test within 30 seconds'}, {'measure': 'Mechanical ventilation', 'timeFrame': 'through study completion, an average of 2 weeks', 'description': 'The number of patients using noninvasive or invasive mechanical ventilation during the study period was counted'}, {'measure': '6 Minutes Walking Distance Test (6MWD)', 'timeFrame': 'Change from baseline 6MWD test at day 7，day 14', 'description': 'The 6-minute walking distance of the two groups was calculated'}, {'measure': "St. George's Respiratory Questionnaire（SGRQ）", 'timeFrame': 'Change from baseline SGRQ scores at day 3，day 7，day 14', 'description': "The St. George's Respiratory Questionnaire (SGRQ) scores will be used to evaluate quality of life with a total score of 0-100. The higher scores will indicate the worse outcomes."}, {'measure': 'The modified COPD Patient-Reported Outcome scale (mCOPD-PRO)', 'timeFrame': 'Change from baseline mPRO-COPD scores at day 3，day 7，day 14', 'description': 'The modified COPD Patient-Reported Outcome scale (mCOPD-PRO) will be used to assess quality of life. The mCOPD-PRO contains 27 items in three domains. mCOPD-PRO scores range from 0 to 4 with a decrease in score showing higher health status.'}, {'measure': 'The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD)', 'timeFrame': 'Change from baseline mESQ-COPD scores at day 3，day 7，day 14', 'description': 'The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD) will be used to assess treatment satisfaction. The mESQ-COPD contains 19 items in four domains. mESQ-COPD scores range from 0 to 4 with a decrease in score showing higher treatment satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic obstructive pulmonary disease', 'Acute exacerbation', 'Pulmonary rehabilitation', 'Supine Daoyin', 'Randomized controlled trail'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the clinical efficacy and safety of supine daoyin in the treatment of AECOPD.', 'detailedDescription': 'Chronic obstructive pulmonary disease (COPD) is a chronic progressive disease with high incidence rate, high mortality rate and high disability rate. Among the people over 40, the prevalence rate is 10.1%, while the prevalence rate in China is 13.7%. Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a major event that affects the natural course of COPD. In particular, most patients with AECOPD have poor prognosis, higher morbidity and mortality, and lower quality of life. Pulmonary rehabilitation can improve the clinical symptoms of AECOPD patients, increase exercise tolerance, delay the decline of lung function, and improve the quality of life. In recent years, the clinical research on the rehabilitation of patients with AECOPD is still in the exploratory stage, which needs to be supported by clear evidence.\n\nThis is a multicenter, randomized controlled trial to evaluate the clinical efficacy and safety of supine daoyin in the treatment of AECOPD. After admission, the patients were randomly divided into two groups, rehabilitation group and control group, 114 cases in each group. After routine treatment, the patients began to recover when they reached the initial rehabilitation standard, and recovered until they reached the discharge standard. The primary outcomes are the length of hospital stay due to acute exacerbation and clinical symptom score. The secondary outcomes include activities of daily living, dyspnea score, 6-minute walking distance, lower limb muscle strength, mechanical ventilation and quality of life. Safety will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A confirmed diagnosis of AECOPD.\n2. Age between 40 and 80 years.\n3. mMRC score ≥ 3.\n4. Barthel index\\<50.\n5. With the informed consent signed.\n\nExclusion Criteria:\n\n1. Patients with severe cognitive impairment, dementia and various psychosis.\n2. Combined with severe arthritis and other osteoarthritis affecting the movement.\n3. Dyskinesia due to neuromuscular diseases.\n4. Long term bedridden for various reasons.\n5. Participating in other trials.'}, 'identificationModule': {'nctId': 'NCT04913961', 'briefTitle': 'Supine Daoyin in the Treatment of AECOPD', 'organization': {'class': 'OTHER', 'fullName': 'Henan University of Traditional Chinese Medicine'}, 'officialTitle': 'Efficacy Evaluation of Supine Daoyin in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Multi-center, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Daoyin for AECOPD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supine Daoyin', 'description': 'During hospitalization, the rehabilitation group will receive conventional western medicine treatment and supine guidance therapy which consists of training and patient education. They will be evaluated with some tests for the study.', 'interventionNames': ['Other: Supine Daoyin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'The control group will get the western medicine conventional therapy with some additional tests for the study.', 'interventionNames': ['Other: western medicine conventional therapy']}], 'interventions': [{'name': 'Supine Daoyin', 'type': 'OTHER', 'description': 'During hospitalization, the rehabilitation group will receive conventional western medicine treatment and supine guidance therapy which consists of training and patient education. They will be evaluated with some tests for the study', 'armGroupLabels': ['Supine Daoyin']}, {'name': 'western medicine conventional therapy', 'type': 'OTHER', 'description': 'The control group will get the western medicine conventional therapy with some additional tests for the study.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jiansheng Li, doctor', 'role': 'CONTACT', 'email': 'li-js8@163.com', 'phone': '+86 371 66248624'}, {'name': 'hailong zhang, doctor', 'role': 'CONTACT', 'email': '13643718969@163.com', 'phone': '+86 371 66248624'}], 'facility': 'The First Affiliated Hospital of Henan University of Chinese', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Zhang hailong, doctor', 'role': 'CONTACT', 'email': 'zhanghailong6@126.com', 'phone': '+86 371 66248624'}, {'name': 'Li jiansheng, doctor', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Li jiansheng, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital of Henan University of Traditional Chinese Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}