Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT04688827
Status:
UNKNOWN
Last Update Posted:
2021-07-08
First Post:
2020-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Additional Resistance Training During Rehabilitation Therapy in Patients With Heart Failure
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-07', 'studyFirstSubmitDate': '2020-12-17', 'studyFirstSubmitQcDate': '2020-12-28', 'lastUpdatePostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VO2peak', 'timeFrame': 'Prior to the intervention', 'description': 'Maximal oxygen consumption during cardiopulmonary exercise test'}, {'measure': 'VO2peak', 'timeFrame': 'After 15 weeks of intervention', 'description': 'Maximal oxygen consumption during cardiopulmonary exercise test'}, {'measure': 'VO2peak', 'timeFrame': 'After 24 weeks of follow-up', 'description': 'Maximal oxygen consumption during cardiopulmonary exercise test'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': 'Prior to the intervention', 'description': 'One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle'}, {'measure': 'Muscle strength', 'timeFrame': 'After 15 weeks of intervention', 'description': 'One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle'}, {'measure': 'Muscle strength', 'timeFrame': 'After 24 weeks of follow-up', 'description': 'One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle'}, {'measure': 'Functional capacity', 'timeFrame': 'Prior to the intervention', 'description': 'Functional capacity evaluated via the six-minute walking test'}, {'measure': 'Functional capacity', 'timeFrame': 'After 15 weeks of intervention', 'description': 'Functional capacity evaluated via the six-minute walking test'}, {'measure': 'Functional capacity', 'timeFrame': 'After 24 weeks of follow-up', 'description': 'Functional capacity evaluated via the six-minute walking test'}, {'measure': 'Quality of life in heart failure patients', 'timeFrame': 'Prior to the intervention', 'description': 'Evaluation via Minnesota living with heart failure questionnaire'}, {'measure': 'Quality of life in heart failure patients', 'timeFrame': 'After 15 weeks of intervention', 'description': 'Evaluation via Minnesota living with heart failure questionnaire'}, {'measure': 'Quality of life in heart failure patients', 'timeFrame': 'After 24 weeks of follow-up', 'description': 'Evaluation via Minnesota living with heart failure questionnaire'}, {'measure': 'Cardiac function', 'timeFrame': 'Prior to the intervention', 'description': 'left-ventricular ejection fraction evaluated by transthoracic echocardiography'}, {'measure': 'Cardiac function', 'timeFrame': 'After 15 weeks of intervention', 'description': 'left-ventricular ejection fraction evaluated by transthoracic echocardiography'}, {'measure': 'Cardiac function', 'timeFrame': 'After 24 weeks of follow-up', 'description': 'left-ventricular ejection fraction evaluated by transthoracic echocardiography'}, {'measure': 'Anthropometric measurements', 'timeFrame': 'Prior to the intervention', 'description': 'body weight evaluated to determine body mass index'}, {'measure': 'Anthropometric measurements', 'timeFrame': 'After 15 weeks of intervention', 'description': 'body weight evaluated to determine body mass index'}, {'measure': 'Anthropometric measurements', 'timeFrame': 'After 24 weeks of follow-up', 'description': 'body weight evaluated to determine body mass index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure', 'resistance training', 'rehabilitation therapy'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The impact of moderate- or low-intensity resistance training will be investigated additional to endurance training in heart failure patients following rehabilitation. The aim is to optimize intensity of resistance training in this patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of heart failure and participation in cardiac rehabilitation\n\nExclusion Criteria:\n\n* Orthopedic disorders, neurological disorders affecting muscle strength, cognitive disorders, heart or arterial surgery (percutaneous coronary intervention, bypass, heart valve surgery) in the last year, acute myocardial infarction in the last 6 months, participation in another intervention'}, 'identificationModule': {'nctId': 'NCT04688827', 'briefTitle': 'Impact of Additional Resistance Training During Rehabilitation Therapy in Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'Impact of Different Types of Resistance Training Additional to Endurance Training During Rehabilitation Therapy in Patients With Heart Failure', 'orgStudyIdInfo': {'id': '2020044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'training group 1: low-intensity resistance training', 'interventionNames': ['Other: Exercise therapy']}, {'type': 'EXPERIMENTAL', 'label': 'training group 2: moderate-intensity resistance training', 'interventionNames': ['Other: Exercise therapy']}], 'interventions': [{'name': 'Exercise therapy', 'type': 'OTHER', 'description': '15 weeks of resistance training (additional to endurance training)', 'armGroupLabels': ['training group 1: low-intensity resistance training', 'training group 2: moderate-intensity resistance training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'country': 'Belgium', 'contacts': [{'name': 'Wilfried Mullens, Professor', 'role': 'CONTACT', 'email': 'wilfried.mullens@uhasselt.be', 'phone': '089 32 50 50', 'phoneExt': '0032'}, {'name': 'Kristof Gelade, Physiotherapist', 'role': 'CONTACT', 'email': 'kristof.gelade@zol.be', 'phone': '089 32 73 41', 'phoneExt': '0032'}], 'facility': 'Ziekenhuis Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}], 'centralContacts': [{'name': 'Dominique Hansen, Professor', 'role': 'CONTACT', 'email': 'dominique.hansen@uhasselt.be', 'phone': '011 29 21 26', 'phoneExt': '0032'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ziekenhuis Oost-Limburg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dominique Hansen', 'investigatorAffiliation': 'Hasselt University'}}}}