Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2025-12-27 @ 9:30 PM
Study NCT ID:
NCT05957861
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2023-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Effectiveness to Web-based Exercise Among Community-dwelling Adults With High Body Fat
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'PI will be blinding.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'we will design a randomized controlled trial comprising two arms of a 16-week exercise web-based aerobic exercise (AE) training and another control group without any exercise intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2023-06-28', 'studyFirstSubmitQcDate': '2023-07-16', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of cholesterol', 'timeFrame': 'two times (from baseline to the end of 16-week)', 'description': 'the unit is mg/dl'}, {'measure': 'The change of fasting sugar from blood sample', 'timeFrame': 'two times (from baseline to the end of 16-week)', 'description': 'the unit is mg/dl'}, {'measure': 'The change of insulin from blood sample', 'timeFrame': 'two times (from baseline to the end of 16-week)', 'description': 'the unit is μIU/mL'}, {'measure': 'The change of weight', 'timeFrame': 'two times (from baseline to the end of 16-week)', 'description': 'weight in kilograms, will be measured using body composition analyzer'}, {'measure': 'The change of waist circumference', 'timeFrame': 'two times (from baseline to the end of 16-week)', 'description': 'the unit is centimeters'}, {'measure': 'The change of body fat percentage', 'timeFrame': 'two times (from baseline to the end of 16-week)', 'description': 'the unit is %, will be measured using body composition analyzer'}, {'measure': 'The change of visceral fat', 'timeFrame': 'two times (from baseline to the end of 16-week)', 'description': 'the unit is square centimeters, will be measured using body composition analyzer'}, {'measure': 'The change of hip circumference', 'timeFrame': 'two times (from baseline to the end of 16-week)', 'description': 'the unit is centimeters.'}, {'measure': 'The change of High-density lipoprotein [HDL]', 'timeFrame': 'two times (from baseline to the end of 16-week)', 'description': 'the unit is mg/dl'}, {'measure': 'The change of low-density lipoprotein [LDH]', 'timeFrame': 'two times (from baseline to the end of 16-week)', 'description': 'the unit is mg/dl'}, {'measure': 'The change of triglycerides [TG]', 'timeFrame': 'two times (from baseline to the end of 16-week)', 'description': 'the unit is mg/dl'}], 'secondaryOutcomes': [{'measure': 'Adherence measurement', 'timeFrame': 'Each exercise session', 'description': 'Number of sessions attended/ Number of total sessions prescribed'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['web-based exercise', 'adherence', 'body composition'], 'conditions': ['Adherence, Treatment', 'Exercise']}, 'descriptionModule': {'briefSummary': 'The study findings can derive an effective exercise type either web-based or supervise exercise as well as build a series of exercise video that can promote self-exercise at home for health promotion for community residents.', 'detailedDescription': 'Background: Web-based exercise is effective alternative training for community residents on health improvement; however, adherence to their performance is challenging.\n\nPurpose: This study aimed to (1) compare the effectiveness of 16-week exercise on improving blood samples, body composition, and anthropometric parameters between web-based exercise and supervised exercise; and (2) examine the trajectory of exercise adherence of web-based exercise for attendance and intensity over time for community-dwelling adults with high body fat.\n\nDesign: A two-arm randomized control trial. Method: Participants who received 16-week supervised exercise for aerobic exercise training on 2020 in our previous project was served as one of control groups (n = 34). In present project, purposive sampling will be used to enroll a target of 66 community-dwelling residents aged 40-64 years with inactive habits and body fat percentage ≧ of 25% for males and ≧ 30% for females in study. Eligible participants will be stratified by sex and then block randomly divided into web-based exercise or a control group (without any exercise intervention). The web-based exercise will prescribe a 30-minute of aerobic exercise at least moderate intensity prescription for three times per week. Heart rate reserve and self-perceived exertion will be self-recorded on the web by participants. Generalized estimating equations will be used to explore the effectiveness of web-based exercise.\n\nImplications: The study findings can derive an effective exercise type either web-based or supervise exercise as well as build a series of exercise video that can promote self-exercise at home for health promotion for community residents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged from 40 to 64 years.\n* have a body fat percentage of ≧25% if a man or ≧30% if a woman.\n* can use the internet for watching the exercise video online.\n* with inactive habit (≤ 3 days of physical activity per week and ≤ 30 min per session).\n\nExclusion Criteria:\n\n* blind.\n* currently under diet control.\n* with any unsafety concern for their condition, such as pregnancy, myocardial infarction, stroke, or body fat percentage of ≧40%.'}, 'identificationModule': {'nctId': 'NCT05957861', 'briefTitle': 'Exploring the Effectiveness to Web-based Exercise Among Community-dwelling Adults With High Body Fat', 'organization': {'class': 'OTHER', 'fullName': 'National Tainan Junior College of Nursing'}, 'officialTitle': 'Exploring the Effectiveness and Trajectory of Adherence to Web-based Exercise Among Community-dwelling Adults With High Body Fat', 'orgStudyIdInfo': {'id': 'National Tainan Junior College'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'web-based exercise', 'description': 'Participants will receive web-based aerobic exercise (AE) training three times per week for 16 weeks.', 'interventionNames': ['Behavioral: web-based aerobic exercise']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'control group without any intervention.'}], 'interventions': [{'name': 'web-based aerobic exercise', 'type': 'BEHAVIORAL', 'description': 'Our designed AE program involved core muscle training through movements including marching, step touches, lunges, v-steps, box steps, twists, knee-ups, scoops, and scissors.', 'armGroupLabels': ['web-based exercise']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yu-Hsuan Chang, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Tainan Junior College of Nursing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'for research privacy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Tainan Junior College of Nursing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Yu-Hsuan Chang', 'investigatorAffiliation': 'National Tainan Junior College of Nursing'}}}}