Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-27 @ 11:40 PM
Study NCT ID:
NCT05543733
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2022-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home Exercise And Resiliency Training (Heart) Club
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 53}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2022-09-13', 'studyFirstSubmitQcDate': '2022-09-13', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Frailty score by the Fried frailty instrument', 'timeFrame': 'day 1 (baseline), week 26 (final visit)', 'description': 'The questionnaire evaluates five components of the frailty syndrome (weakness, slowness, shrinkage, exhaustion, and diminished physical activity). Sum of the components will have a possible score of 0-5: not frail (score 0), pre-frail (score 1-2), frail (score great or equal to 3), undetermined (missing component).'}], 'secondaryOutcomes': [{'measure': 'Change in 7-day average step count over 6 month period', 'timeFrame': 'Baseline, 6 months'}, {'measure': 'Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - 29', 'timeFrame': 'day 1 (baseline), week 26 (final visit)', 'description': 'This survey has 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function on a scale of 1 (worst) to 5 (best), and pain intensity (on a scale ranging from 0 (no pain) to 10 (worst pain imaginable).'}, {'measure': 'Change in 6-minute walk distance', 'timeFrame': 'day 1 (baseline), week 26 (final visit)'}, {'measure': 'Change in peak oxygen consumption', 'timeFrame': 'day 1 (baseline), week 26 (final visit)', 'description': 'This is measured during a Cardiopulmonary Exercise Testing (CPET) test measured in milliliters per minute (mL/min).'}, {'measure': 'Change in oxygen consumption at anaerobic threshold', 'timeFrame': 'day 1 (baseline), week 26 (final visit)', 'description': 'This is measured during a CPET.'}, {'measure': 'Change in liver stiffness measured by ultrasound', 'timeFrame': 'day 1 (baseline), week 26 (final visit)', 'description': 'This is measured during ultrasound, units meters per second (m/sec)'}, {'measure': 'Change in alpha fetoprotein (AFP)', 'timeFrame': 'day 1 (baseline), week 26 (final visit)', 'description': 'This is a blood sample.'}, {'measure': 'Change in Aspartate Transferase (AST)', 'timeFrame': 'day 1 (baseline), week 26 (final visit)', 'description': 'This is a blood sample.'}, {'measure': 'Change in Alanine Aminotransferase (ALT)', 'timeFrame': 'day 1 (baseline), week 26 (final visit)', 'description': 'This is a blood sample.'}, {'measure': 'Change in platelets', 'timeFrame': 'day 1 (baseline), week 26 (final visit)', 'description': 'This is a blood sample.'}, {'measure': 'Change in Gamma-glutamyl Transferase (GGT)', 'timeFrame': 'day 1 (baseline), week 26 (final visit)', 'description': 'This is a blood sample.'}, {'measure': 'Change in Enhanced Liver Fibrosis (Elf) Score number', 'timeFrame': 'day 1 (baseline), week 26 (final visit)', 'description': 'This is a blood sample.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise program', 'Liver stiffness'], 'conditions': ['Fontan Physiology', 'Frailty']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to evaluate the impact of a telemedicine-based structured home exercise program on frailty and exercise capacity in individuals with Fontan heart physiology, demonstrate that a telemedicine exercise program reduces socioeconomic and geographic barriers to access to exercise training, and to explore the impact of a structured exercise program on markers of Fontan-associated liver disease.', 'detailedDescription': 'This study will require two in-person visits to the exercise physiology lab as well as virtual follow-up visits. Visit one will require participants to complete a cardiopulmonary exercise test (CPET), liver ultrasound, 6-minute walk, grip strength test, arm circumference measure, body composition analysis, anthropometrics measurement, surveys and a biomarker blood sample collection. The second in-person visit will require participants to complete a final cardiopulmonary exercise test, liver ultrasound, 6-minute walk, grip strength test and arm circumference, biomarker blood sample and final survey.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females with Fontan physiology\n* 19 years old at age of enrollment\n\nExclusion Criteria:\n\n* Height less than 130 centimeter (cm)\n* Pregnancy or the plan to become pregnant during the study period\n* Current intravenous inotropic drugs\n* Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within six months prior to enrollment\n* Severe valvar regurgitation, ventricular outflow obstruction, or aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment\n* History of arrhythmia with exercise (excluding isolated supraventricular or ventricular ectopy without symptoms)\n* Inability to complete exercise testing at baseline screening\n* Noncardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results'}, 'identificationModule': {'nctId': 'NCT05543733', 'briefTitle': 'Home Exercise And Resiliency Training (Heart) Club', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Home Exercise And Resiliency Training (HEART) Club: A Virtual Care at Home Program to Reduce Frailty for Adults With Fontan Circulation', 'orgStudyIdInfo': {'id': 'HUM00220044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home exercise program', 'interventionNames': ['Behavioral: Home exercise program']}], 'interventions': [{'name': 'Home exercise program', 'type': 'BEHAVIORAL', 'description': 'Participants will complete a 6-month prescription telemedicine-based structured home exercise program. Baseline information will be used to develop a personalized home exercise program. This program will involve downloading the MyDataHelps application on a mobile device to securely collect wearable device information like step counts, activity minutes, and heart rate. Additionally, participants will have multiple virtual visits as well as the 2 in-person visits.', 'armGroupLabels': ['Home exercise program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Blake Armstrong', 'role': 'CONTACT', 'email': 'blar@umich.edu', 'phone': '734-615-4899'}, {'name': 'Jesse Hansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Blake Armstrong', 'role': 'CONTACT', 'email': 'blar@umich.edu', 'phone': '734-615-4899'}], 'overallOfficials': [{'name': 'Jesse Hansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Jesse Hansen', 'investigatorAffiliation': 'University of Michigan'}}}}