Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
Study NCT ID:
NCT04670367
Status:
UNKNOWN
Last Update Posted:
2020-12-17
First Post:
2020-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Baduanjin Exercise on Meridian Energy and Heart Rate Variability in Patients Undergoing Cardiac Sugery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016138', 'term': 'Walking'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-11-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-15', 'studyFirstSubmitDate': '2020-11-29', 'studyFirstSubmitQcDate': '2020-12-15', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of 24 points skin electric conductance over bilateral wrist and foot in patients undergoing open-heart surgery as assessed using M.E.A.D (Meridian Energy Analysis Device)：Baseline', 'timeFrame': 'Baseline', 'description': 'The electrical conductance of the acupuncture points of human subject can be measured by a computerized testing instrument with a very low electrical current.Ryodoraku theory has been shown to be a supplementary diagnostic method for selective diseases and a useful parameter for evaluating therapeutic effects of acupuncture. The electrical conductance of an acupoint was measured using a Meridian Energy Analysis Device (MEAD100, Med- Pex Enterprises, Taichung, Taiwan) operating at DC 12V and 0 to 200A. The method and procedure of the MEAD is based on the Ryodoraku theory and is similar to equipment used in previous studies.'}, {'measure': 'The change of 24 points skin electric conductance over bilateral wrist and foot in patients undergoing open-heart surgery as assessed using M.E.A.D (Meridian Energy Analysis Device)： 2 weeks', 'timeFrame': '2 weeks', 'description': 'The electrical conductance of the acupuncture points of human subject can be measured by a computerized testing instrument with a very low electrical current.Ryodoraku theory has been shown to be a supplementary diagnostic method for selective diseases and a useful parameter for evaluating therapeutic effects of acupuncture. The electrical conductance of an acupoint was measured using a Meridian Energy Analysis Device (MEAD100, Med- Pex Enterprises, Taichung, Taiwan) operating at DC 12V and 0 to 200A. The method and procedure of the MEAD is based on the Ryodoraku theory and is similar to equipment used in previous studies.'}, {'measure': 'The change of 24 points skin electric conductance over bilateral wrist and foot in patients undergoing open-heart surgery as assessed using M.E.A.D (Meridian Energy Analysis Device)： 4 weeks', 'timeFrame': '4 weeks', 'description': 'The electrical conductance of the acupuncture points of human subject can be measured by a computerized testing instrument with a very low electrical current.Ryodoraku theory has been shown to be a supplementary diagnostic method for selective diseases and a useful parameter for evaluating therapeutic effects of acupuncture. The electrical conductance of an acupoint was measured using a Meridian Energy Analysis Device (MEAD100, Med- Pex Enterprises, Taichung, Taiwan) operating at DC 12V and 0 to 200A. The method and procedure of the MEAD is based on the Ryodoraku theory and is similar to equipment used in previous studies.'}, {'measure': 'The change of 24 points skin electric conductance over bilateral wrist and foot in patients undergoing open-heart surgery as assessed using M.E.A.D (Meridian Energy Analysis Device)： 12 weeks', 'timeFrame': '12 weeks', 'description': 'The electrical conductance of the acupuncture points of human subject can be measured by a computerized testing instrument with a very low electrical current.Ryodoraku theory has been shown to be a supplementary diagnostic method for selective diseases and a useful parameter for evaluating therapeutic effects of acupuncture. The electrical conductance of an acupoint was measured using a Meridian Energy Analysis Device (MEAD100, Med- Pex Enterprises, Taichung, Taiwan) operating at DC 12V and 0 to 200A. The method and procedure of the MEAD is based on the Ryodoraku theory and is similar to equipment used in previous studies.'}, {'measure': 'The change of 24 points skin electric conductance over bilateral wrist and foot in patients undergoing open-heart surgery as assessed using M.E.A.D (Meridian Energy Analysis Device)： 16 weeks', 'timeFrame': '16 weeks', 'description': 'The electrical conductance of the acupuncture points of human subject can be measured by a computerized testing instrument with a very low electrical current.Ryodoraku theory has been shown to be a supplementary diagnostic method for selective diseases and a useful parameter for evaluating therapeutic effects of acupuncture. The electrical conductance of an acupoint was measured using a Meridian Energy Analysis Device (MEAD100, Med- Pex Enterprises, Taichung, Taiwan) operating at DC 12V and 0 to 200A. The method and procedure of the MEAD is based on the Ryodoraku theory and is similar to equipment used in previous studies.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Open Heart Surgery']}, 'descriptionModule': {'briefSummary': 'Cardiac rehabilitation (CR) consists of supervised exercise training in conjunction with other secondary prevention interventions. However, CR is not widely used because of distance, financial resources, work and other time constraints, gender, age, social support, illness perceptions, and psychiatric problems. Baduanjin is a type of movement-based mind-body intervention. It is a form of traditional practice designed to promote physical and psychological health, manage symptoms, and relieve stress during illness. Patients with heart disease have frequently used it. The impacts of a Baduanjin exercise-based cardiac rehabilitation program for patients recovering from CAD under coronary artery bypass graft (CABG) or valve replacement on Meridian Energy Analysis Device (MEAD100, Med- Pex Enterprises, Taichung, Taiwan) and heart rate variability (HRV) has yet to be assessed. This trial evaluates whether the Baduanjin exercise would provide effective meridian energy and HRV in patients following CABG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 25-70 age range\n* Undergoing open heart surgery\n* Hemodynamically stable\n* Ambulatory\n* No advanced vision defect\n* The physician authorized by the operating physician for participation in the exercise\n* Patients who agreed to participate in the study.\n\nExclusion Criteria:\n\n* The presence of pulmonary, neurological, musculoskeletal disease limiting participation in exercise training\n* Patients at high risk (ejection fraction below 40 percent)\n* Dissectant aneurysm\n* Patients who cannot be cooperative in verbal and / or auditory terms\n* Psychological and / or perceptual cooperative patients'}, 'identificationModule': {'nctId': 'NCT04670367', 'briefTitle': 'The Effects of Baduanjin Exercise on Meridian Energy and Heart Rate Variability in Patients Undergoing Cardiac Sugery', 'organization': {'class': 'OTHER', 'fullName': 'Tzu Chi University'}, 'officialTitle': 'Baduanjin Exercise on Cardiac Surgery', 'orgStudyIdInfo': {'id': 'TCU-CHHuang-BaduanjinHeart'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm A: usual care', 'description': 'routine usual care', 'interventionNames': ['Other: usual care']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: walk', 'description': 'walk 30mins per day, 5 days per week.', 'interventionNames': ['Behavioral: Walk 30mins']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C: Baduanjin', 'description': 'Baduanjin 12 mins per day, 5 days per week.', 'interventionNames': ['Behavioral: Baduanjin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D: Baduanjin plus walk', 'description': 'walk 30mins then Baduanjin 12 mins per day, 5 days per week.', 'interventionNames': ['Behavioral: Walk plus Baduanjin']}], 'interventions': [{'name': 'Walk 30mins', 'type': 'BEHAVIORAL', 'description': 'aerobic exercise', 'armGroupLabels': ['Arm B: walk']}, {'name': 'Walk plus Baduanjin', 'type': 'BEHAVIORAL', 'description': 'Walk 30mins then Baduanjin 12mins per day, 5 times per week.', 'armGroupLabels': ['Arm D: Baduanjin plus walk']}, {'name': 'usual care', 'type': 'OTHER', 'description': 'routine care', 'armGroupLabels': ['Arm A: usual care']}, {'name': 'Baduanjin', 'type': 'BEHAVIORAL', 'description': "Baduanjin exercise is moderate in intensity and short in duration (a set of Baduanjin takes about 12 minutes). Baduanjin consists of the sitting and standing practicing form. The sitting Baduanjin exercise conforms to the aspects of low-intensity and long-term aerobic activity, which is suitable for the rehabilitation training of patients who are in stable condition during hospitalization. The standing Baduanjin is more suitable for patients with sequential rehabilitation after discharge and can be adjusted based on the patient's condition", 'armGroupLabels': ['Arm C: Baduanjin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90093', 'city': 'Hualien City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chun Hou Huang, Phd', 'role': 'CONTACT', 'email': 'hou2017@gms.tcu.edu.tw', 'phone': '886-978650985'}], 'facility': 'Tzu Chi University', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}], 'centralContacts': [{'name': 'Chu Hou Huang, PhD', 'role': 'CONTACT', 'email': 'hou2017@gms.tcu.edu.tw', 'phone': '886-3-565301'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tzu Chi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistance Professor', 'investigatorFullName': 'Chun Hou Huang', 'investigatorAffiliation': 'Tzu Chi University'}}}}