Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 4:08 AM
Study NCT ID:
NCT06219512
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-23
First Post:
2023-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Effect of Individualized Exercise Prescription for Hypertension With 6-minute Walking Test (6MWT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-12', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2024-01-12', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure, SBP', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'systolic blood pressure (mmHg)'}, {'measure': 'Diastolic blood pressure, DBP', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'diastolic blood pressure (mmHg)'}, {'measure': 'Heart rate, HR', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Heart rate (beats/min)'}, {'measure': 'Pulse wave velocity, PWV', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'pulse wave velocity'}, {'measure': 'PWV', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'pulse wave velocity'}, {'measure': 'weight', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'weight (kg)'}, {'measure': 'Body mass index, BMI', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'body mass index （kg/m\\^2）'}], 'secondaryOutcomes': [{'measure': 'Blood lipids', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Triglyceride, total cholesterol, low-density lipoprotein cholesterol'}, {'measure': 'exercise hypertension', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'yes/no'}, {'measure': 'circadian rhythm of blood pressure', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Ambulatory blood pressure monitoring'}, {'measure': 'anxiety', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Anxiety score using Generalized Anxiety Disorder (GAD-7). High GAD-7 scores significantly predicted worse state of anxiety: no anxiety,0-4 scores; mild anxiety,5-9 scores; moderate anxiety,10-14 scores; severe anxiety,15-21 scores.'}, {'measure': 'depression', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Depression score using Patient Health Questionnaire-9 (PHQ-9). High PHQ-9 scores significantly predicted worse state of depression: no depression,0-4 scores; mild depression,5-9 scores; moderate depression,10-14 scores; severe depression,15-27 scores.'}, {'measure': 'use of antihypertensive drugs', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Record dosage and numbers of antihypertensive drugs using questionnaires.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertension', 'Exercise prescription', 'Intelligent information management', '6-min walking test (6MWT)', 'Cardiopulmonary exercise test (CPET)'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '32860412', 'type': 'BACKGROUND', 'citation': 'Pelliccia A, Sharma S, Gati S, Back M, Borjesson M, Caselli S, Collet JP, Corrado D, Drezner JA, Halle M, Hansen D, Heidbuchel H, Myers J, Niebauer J, Papadakis M, Piepoli MF, Prescott E, Roos-Hesselink JW, Graham Stuart A, Taylor RS, Thompson PD, Tiberi M, Vanhees L, Wilhelm M; ESC Scientific Document Group. 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease. Eur Heart J. 2021 Jan 1;42(1):17-96. doi: 10.1093/eurheartj/ehaa605. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Obesity and lack of exercise are one of the reasons for high blood pressure. Exercise can reduce the risk of cardiovascular events by reducing weight and blood pressure. The precise formulation of exercise prescription by cardiopulmonary exercise test (CPET) can effectively control hypertension. Our research group has formulated 50 "exercise prescriptions for hypertension population" in the early stage, but how to further effectively implement them needs to be discussed.\n\nBased on the previous experience of undertaking the project "Exercise Prescription for Hypertensive People" of General Administration of Sport of the People\'s Republic of China, this research group discussed the important role of intelligent information management in the clinical effect evaluation and effective implementation of exercise prescription for hypertension; To explore the feasibility of making exercise prescription for hypertension based on 6-min walking test, and whether it is not inferior to or equivalent to the accuracy and effectiveness of making exercise prescription by CPET. The relevant results will lay a foundation for exploring the broader adaptation of hypertension exercise prescription to the population.', 'detailedDescription': 'The 6-minute walking test (6MWT) has good universality and accessibility, and can be used as the basis for formulating exercise prescriptions. According to the consensus of Chinese experts on the application of clinical norms of the six-minute walking test, it is recommended to formulate individualized exercise prescriptions based on the average walking speed of 6MWT calculated from the six-minute walking distance (6MWD), but there is no relevant content about hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight/obesity; Normal or normal high blood pressure after drug use; Grade 1 hypertension (whether taking medicine or not); Having sports habits; Sports risk is low and medium\n\nExclusion Criteria:\n\n* ≥ grade 2 Hypertension; High-risk hypertensive patients; Malignant hypertension, secondary hypertension, etc; Serious arrhythmia, heart failure, acute myocardial infarction; Severe stroke, liver and kidney insufficiency; Physical dysfunction and failure to cooperate for various reasons; Unable to conduct CPET; The Types and doses of antihypertensive drugs is still in the process of adjustment'}, 'identificationModule': {'nctId': 'NCT06219512', 'briefTitle': 'Clinical Effect of Individualized Exercise Prescription for Hypertension With 6-minute Walking Test (6MWT)', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Evaluation of the Clinical Effect of the Formulation of Individualized Exercise Prescription for Hypertension With 6-minute Walking Test (6MWT)', 'orgStudyIdInfo': {'id': 'RDL2022-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPET exercise prescription group', 'description': 'Formulate exercise prescription of cardiopulmonary exercise test (CPET) according to the principle of FITT \\[frequency, intensity, time and type\\]', 'interventionNames': ['Behavioral: CPET exercise prescription']}, {'type': 'EXPERIMENTAL', 'label': '6MWT exercise prescription group', 'description': 'Exercise prescription is set according to the recommendation of the Chinese expert consensus on the application of clinical norms of six-minute walking test', 'interventionNames': ['Behavioral: 6MWT exercise prescription']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Regular exercise group', 'description': 'Carry out regular exercise as usual', 'interventionNames': ['Behavioral: Regular exercise']}], 'interventions': [{'name': 'CPET exercise prescription', 'type': 'BEHAVIORAL', 'description': 'Exercise mode: walk Frequency: 5 times/week', 'armGroupLabels': ['CPET exercise prescription group']}, {'name': '6MWT exercise prescription', 'type': 'BEHAVIORAL', 'description': 'Exercise mode: walk Frequency: 5 times/week', 'armGroupLabels': ['6MWT exercise prescription group']}, {'name': 'Regular exercise', 'type': 'BEHAVIORAL', 'description': 'Regular exercise', 'armGroupLabels': ['Regular exercise group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yang Xi, Doctor', 'role': 'CONTACT', 'email': 'yangxi1016@sina.com', 'phone': '+86-10-88325552'}], 'overallOfficials': [{'name': 'Yang Xi, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'To protect the privacy of patients in the maximum extent'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Yang Xi', 'investigatorAffiliation': "Peking University People's Hospital"}}}}