Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT06756659
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2024-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-based Cardiac Rehabilitation With Spot-jogging
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2024-12-08', 'studyFirstSubmitQcDate': '2024-12-25', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiopulmonary exercise test', 'timeFrame': 'baseline at enrollment and the end of treatment at 9 weeks (after 18 exercise sessions)'}], 'secondaryOutcomes': [{'measure': 'Six-minute walking test', 'timeFrame': 'baseline at enrollment and the end of treatment at 9 weeks (after 18 exercise sessions)'}, {'measure': '36-Item Short Form Health Survey', 'timeFrame': 'baseline at enrollment and the end of treatment at 9 weeks (after 18 exercise sessions)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HF', 'CR'], 'conditions': ['Heart Failure', 'Cardiac Rehabilitation']}, 'referencesModule': {'references': [{'pmid': '27848017', 'type': 'RESULT', 'citation': 'Ikenaga M, Yamada Y, Kose Y, Morimura K, Higaki Y, Kiyonaga A, Tanaka H; Nakagawa Study Group. Effects of a 12-week, short-interval, intermittent, low-intensity, slow-jogging program on skeletal muscle, fat infiltration, and fitness in older adults: randomized controlled trial. Eur J Appl Physiol. 2017 Jan;117(1):7-15. doi: 10.1007/s00421-016-3493-9. Epub 2016 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'The first purpose of this study is to investigate the physiological changes of heart failure patients during cardiopulmonary exercise test with spot jogging and compare them with the standard stationary bike cardiopulmonary exercise test. The second one is to compare the effect between home-based cardiac rehabilitation using different step frequency and toe lift or not to adjust spot jogging intensity and outpatient center-based cardiac rehabilitation for heart failure patients.', 'detailedDescription': 'This is a pilot, prospective, randomized controlled trial design. We will recruit 40 heart failure patients aged over 18 year-old who have completed stationary bike cardiopulmonary exercise test and was referred to phase II cardiac rehabilitation. After providing informed consent, participants will be randomly assigned to either the home-based cardiac rehabilitation group or the outpatient center-based cardiac rehabilitation group. All participants will undergo spot jogging cardiopulmonary exercise test and six-minute walking test. The home-based spot jogging cardiac rehabilitation group will receive exercise intensity guidance in the outpatient cardiac rehabilitation room for 30 minutes of spot jogging and treadmill exercise during the first, fourth, and seventh weeks, and will perform spot jogging for 30 minutes twice a week at home. The outpatient center-based cardiac rehabilitation group will perform stationary bike or treadmill exercise for 30 minutes twice a week in the outpatient cardiac rehabilitation room. Both groups will achieve their target heart rate or 13 in rating perceived exertion. After 18 exercise sessions, participants will undergo stationary bike exercise test and six-minute walking test again.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heart failure patients aged over 18 year-old who have completed stationary bike cardiopulmonary exercise test and was referred to phase II cardiac rehabilitation.\n\nExclusion Criteria:\n\n* Atrial fibrillation\n* Other neurological or musculoskeletal issues that affect physical activity.\n* Undergoing dialysis.\n* Having a pacemaker.\n* Unable to cooperate in completing cardiopulmonary exercise testing.\n* Do not agree to participate in the trial.'}, 'identificationModule': {'nctId': 'NCT06756659', 'briefTitle': 'Home-based Cardiac Rehabilitation With Spot-jogging', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Comparison of the Effectiveness Between Home-based Cardiac Rehabilitation With Spot-jogging and Outpatient Center-Based Cardiac Rehabilitation in Patients With Heart Failure.', 'orgStudyIdInfo': {'id': '202406057RIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'home-based cardiac rehabilitation group', 'description': 'All participants will undergo spot jogging cardiopulmonary exercise test and six-minute walking test. The home-based spot jogging cardiac rehabilitation group will receive exercise intensity guidance in the outpatient cardiac rehabilitation room for 30 minutes of spot jogging and treadmill exercise during the first, fourth, and seventh weeks, and will perform moderate-intensity spot jogging for 30 minutes twice a week at home.', 'interventionNames': ['Other: Home-based spot jogging']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'outpatient center-based cardiac rehabilitation group', 'description': 'All participants will undergo spot jogging cardiopulmonary exercise test and six-minute walking test. The outpatient center-based cardiac rehabilitation group will perform moderate-intensity stationary bike or treadmill exercise for 30 minutes twice a week in the outpatient cardiac rehabilitation room.', 'interventionNames': ['Other: Center-based exercise training']}], 'interventions': [{'name': 'Center-based exercise training', 'type': 'OTHER', 'description': 'All participants will undergo a spot jogging cardiopulmonary exercise test and a six-minute walking test. The outpatient center-based cardiac rehabilitation group will perform moderate-intensity stationary biking or treadmill exercise for 30 minutes, twice a week, under the supervision of a physical therapist in the outpatient cardiac rehabilitation room.', 'armGroupLabels': ['outpatient center-based cardiac rehabilitation group']}, {'name': 'Home-based spot jogging', 'type': 'OTHER', 'description': 'The home-based spot jogging cardiac rehabilitation group will receive exercise intensity guidance in the outpatient cardiac rehabilitation room for 30 minutes of spot jogging and treadmill exercise during the first, fourth, and seventh weeks. They will then perform moderate-intensity spot jogging at home for 30 minutes, twice a week, at a perceived exertion level of 13 out of 20 on the RPE scale.', 'armGroupLabels': ['home-based cardiac rehabilitation group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ting Teng', 'role': 'CONTACT', 'email': 'ting15209@gmail.com', 'phone': '＋886-2-23123456', 'phoneExt': '265291'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Ting Teng Physical Therapist', 'role': 'CONTACT', 'email': 'ting15209@gmail.com', 'phone': '+886 23123456', 'phoneExt': '265291'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}