Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT03180320
Status:
RECRUITING
Last Update Posted:
2025-05-18
First Post:
2017-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Baduanjin-eight-silken-movement With Self-efficacy Building for Patients With Chronic Heart Failure (BESMILE-HF Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Given the nature of the intervention, it is not possible to blind the patients and personnel involved in conducting the programs.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2017-06-02', 'studyFirstSubmitQcDate': '2017-06-06', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'IPAQ', 'timeFrame': 'Baseline, 4 week, 8 week, 12 week', 'description': 'International Physical Activity Questionnaire'}, {'measure': 'Adverse events', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Safety assessment'}, {'measure': 'MACEs', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Major acute cardiac events'}, {'measure': 'SDANN Index', 'timeFrame': 'Baseline, 12 week', 'description': 'Parameters from Holter 24-hour ECG'}, {'measure': 'SDNN Index', 'timeFrame': 'Baseline, 12 week', 'description': 'Parameters from Holter 24-hour ECG'}, {'measure': 'All-caused mortality All-caused mortality', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'All-caused mortality'}, {'measure': 'All-caused hospitalization', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'All-caused hospitalization'}, {'measure': 'Heart failure hospitalizaiton', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Heart failure hospitalizaiton'}], 'primaryOutcomes': [{'measure': 'Change from baseline peak VO2 (ml/kg/min) at 12 week', 'timeFrame': 'Baseline, 12 week', 'description': 'Peak oxygen uptake'}, {'measure': 'Change from baseline MLHFQ at 12 week', 'timeFrame': 'Baseline,12 week', 'description': 'Minnesota Living with Heart Failure Questionnaire'}], 'secondaryOutcomes': [{'measure': '6MWT', 'timeFrame': 'Baseline, 4 week, 8 week, 12 week', 'description': '6-minute walking test'}, {'measure': 'TGUG', 'timeFrame': 'Baseline, 4 week, 8 week, 12 week', 'description': 'Timed get-up and-go'}, {'measure': 'SEE-C', 'timeFrame': 'Baseline, 4 week, 8 week, 12 week', 'description': 'Exercise Self-efficacy'}, {'measure': 'MLHFQ', 'timeFrame': 'Baseline, 4 week, 8 week, 12 week', 'description': 'Minnesota Living with Heart Failure Questionnaire'}, {'measure': 'EQ-5D', 'timeFrame': 'Baseline, 4 week, 8 week, 12 week', 'description': 'General quality of life'}, {'measure': 'GRC', 'timeFrame': 'Baseline, 4 week, 8 week, 12 week', 'description': 'Global Rating of Change'}, {'measure': 'LVEDD (mm)', 'timeFrame': 'Baseline, 12 week', 'description': 'Parameters from echocardiography: Dimensions and volumes'}, {'measure': 'LA (mm)', 'timeFrame': 'Baseline, 12 week', 'description': 'Parameters from echocardiography: Dimensions and volumes'}, {'measure': 'LVEF (%)', 'timeFrame': 'Baseline, 12 week', 'description': 'Parameters from echocardiography: Left ventricular systolic function'}, {'measure': 'Global longitudinal strain 2D (%)', 'timeFrame': 'Baseline, 12 week', 'description': 'Parameters from echocardiography: Left ventricular systolic function'}, {'measure': 'E/A ratio', 'timeFrame': 'Baseline, 12 week', 'description': 'Parameters from echocardiography: Left ventricular diastolic function'}, {'measure': 'NT pro-BNP', 'timeFrame': 'Baseline, 12 week', 'description': 'Prognostic biomarker from blood sample'}, {'measure': 'hsCRP', 'timeFrame': 'Baseline, 12 week', 'description': 'Inflammatory indicator from blood sample'}, {'measure': 'Total score of Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Baseline, 4 week, 8 week, 12 week', 'description': 'The total score ranges from 0-27, the higher scores indicates worse outcomes'}, {'measure': 'Total score of General Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Baseline, 4 week, 8 week, 12 week', 'description': 'The total score ranges from 0-21, the higher scores indicates worse outcomes'}, {'measure': 'Number of patients who has a increand 6% PeakVO2', 'timeFrame': 'Baseline, 12 week', 'description': 'Number of patients who has a increand 6% PeakVO2'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic heart failure', 'exercise-based cardiac rehabilitation', 'Baduanjin'], 'conditions': ['Heart Failure NYHA Class II', 'Heart Failure NYHA Class III', 'Heart Failure']}, 'referencesModule': {'references': [{'pmid': '36894879', 'type': 'DERIVED', 'citation': 'Sun P, Cen H, Chen S, Chen X, Jiang W, Zhu H, Liu Y, Liu H, Lu W. Left atrial dysfunction can independently predict exercise capacity in patients with chronic heart failure who use beta-blockers. BMC Cardiovasc Disord. 2023 Mar 9;23(1):128. doi: 10.1186/s12872-023-03127-9.'}, {'pmid': '34386535', 'type': 'DERIVED', 'citation': 'Chen X, Jiang W, Olson TP, Lundborg CS, Wen Z, Lu W, Marrone G. Feasibility and Preliminary Effects of the BESMILE-HF Program on Chronic Heart Failure Patients: A Pilot Randomized Controlled Trial. Front Cardiovasc Med. 2021 Jul 27;8:715207. doi: 10.3389/fcvm.2021.715207. eCollection 2021.'}, {'pmid': '29490680', 'type': 'DERIVED', 'citation': 'Chen X, Jiang W, Lin X, Lundborg CS, Wen Z, Lu W, Marrone G. Effect of an exercise-based cardiac rehabilitation program "Baduanjin Eight-Silken-Movements with self-efficacy building" for heart failure (BESMILE-HF study): study protocol for a randomized controlled trial. Trials. 2018 Mar 1;19(1):150. doi: 10.1186/s13063-018-2531-9.'}]}, 'descriptionModule': {'briefSummary': "Chronic heart failure (CHF) is a major and growing public health problem and poses economic burden on the society. There is a need for a safe, equipment-free, low-cost, and easily implemented exercise-based cardiac rehabilitation program for CHF patients in China. Baduanjin exercise, translated as 'eight silken movements', is one of the most common forms of traditional Chinese exercise and it could have value to be integrated into a exercise-based cardiac rehabilitation program for CHF patients, together with education, evaluation and consultancy. Accordingly, the BESMILE-HF program applying the Baduanjin exercise as the central component, has been developed in Guangdong Provincial Hospital of Chinese Medicine which is one of the largest hospitals of Chinese medicine in China. This project is to evaluate the efficacy and acceptability of BESMILE-HF program in patients with CHF in China, and it will be based on a randomized controlled trial and a qualitative study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged 18 years or above\n2. diagnosed with chronic heart failure\n3. clinically stable as defined as symptoms and signs that have remained generally unchanged for at least 1 month\n4. NYHA functional class II or III\n\nExclusion Criteria:\n\n1. patients who have contraindications to cardiopulmonary test\n2. patients who have contraindications to exercise training\n3. Patients who have serious acute or chronic organic disease or mental disorders\n4. history of cardiac surgery, cardiac resynchronization therapy, or intracardiac defibrillation within the previous 3 months;\n5. history of cardiac arrest within 1 year;\n6. history of peripartum cardiomyopathy, hyperthyroid heart disease, primary pulmonary hypertension;\n7. inability to perform a bicycle stress test;\n8. severe cognitive dysfunction precluding informed consent or understanding of exercise concepts;\n9. current regular Baduanjin or current participation in a conventional cardiac rehabilitation program\n10. current participation in another trial.'}, 'identificationModule': {'nctId': 'NCT03180320', 'acronym': 'BESMILE-HF', 'briefTitle': 'Baduanjin-eight-silken-movement With Self-efficacy Building for Patients With Chronic Heart Failure (BESMILE-HF Study)', 'organization': {'class': 'OTHER', 'fullName': 'Guangdong Provincial Hospital of Traditional Chinese Medicine'}, 'officialTitle': "Effect of an Exercise-based Cardiac Rehabilitation Program 'Baduanjin-eight-silken-movement With Self-efficacy Building' for Patients With Chronic Heart Failure in Guangzhou, China (BESMILE-HF Study)", 'orgStudyIdInfo': {'id': 'B2016-202-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BESMILE-HF group', 'description': 'Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines. In addition, patients will receive the BESMILE-HF program.', 'interventionNames': ['Behavioral: BESMILE-HF program', 'Drug: Usual medications']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Patients in the control group will receive only the usual medications, since patients typically do not receive exercise-based cardiac rehabilitation in this kind of setting.', 'interventionNames': ['Drug: Usual medications']}], 'interventions': [{'name': 'BESMILE-HF program', 'type': 'BEHAVIORAL', 'description': 'The following activities will be conducted as part of the BESMILE-HF program:\n\n1. Baduanjin exercise;\n2. evaluations of exercise capacity and clinical conditions;\n3. consultations on exercise prescription and management of symptoms/signs during exercise;\n4. education covering topics related to the CHF and exercise; and\n5. a series of adherence strategies.', 'armGroupLabels': ['BESMILE-HF group']}, {'name': 'Usual medications', 'type': 'DRUG', 'description': 'Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines.', 'armGroupLabels': ['BESMILE-HF group', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lu Weihui', 'role': 'CONTACT'}], 'facility': 'Guangdong Provincial Hospital of Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Weihui Lu', 'role': 'CONTACT', 'email': 'weihui.lu@163.com', 'phone': '+86(020)81887233', 'phoneExt': '35837'}, {'name': 'Xiankun Chen', 'role': 'CONTACT', 'email': 'chenxiankun232323@126.com', 'phone': '+86(020)81887233', 'phoneExt': '35837'}], 'overallOfficials': [{'name': 'Weihui Lu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangdong Provincial Hospital of Traditional Chinese Medicine'}, {'name': 'Gaetano Marrone', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Wei Jiang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangdong Provincial Hospital of Traditional Chinese Medicine'}, {'name': 'Zehuai Wen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guangdong Provincial Hospital of Traditional Chinese Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Provincial Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Weihui Lu', 'investigatorAffiliation': 'Guangdong Provincial Hospital of Traditional Chinese Medicine'}}}}