Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT05537467
Status:
RECRUITING
Last Update Posted:
2024-12-18
First Post:
2022-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients
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': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2022-09-09', 'studyFirstSubmitQcDate': '2022-09-09', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in O2 consumption (VO2) [L/min]', 'timeFrame': '15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)', 'description': 'Assess above performance parameters in CPX and compare between Music and Non-Music arm.'}, {'measure': 'Difference in CO2 production (VCO2) [L/min]', 'timeFrame': '15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)', 'description': 'Assess above performance parameters in CPX and compare between Music and Non-Music arm.'}, {'measure': 'Difference in respiratory exchange ratio (RER)', 'timeFrame': '15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)', 'description': 'Assess above performance parameters in CPX and compare between Music and Non-Music arm.'}, {'measure': 'Difference in Minute Ventilation (VE) [L/min]', 'timeFrame': '15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)', 'description': 'Assess above performance parameters in CPX and compare between Music and Non-Music arm'}, {'measure': 'Difference in Ventilatory Threshold (VT) [L]', 'timeFrame': '15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)', 'description': 'Assess above performance parameters in CPX and compare between Music and Non-Music arm'}, {'measure': 'Difference in respiratory rate (RR) [Breaths per minute]', 'timeFrame': '15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)', 'description': 'Assess above performance parameters in CPX and compare between Music and Non-Music arm'}, {'measure': 'Difference in Ventilatory Equivalent of CO2 (VE/VCO2)', 'timeFrame': '15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)', 'description': 'Assess above performance parameters in CPX and compare between Music and Non-Music arm'}], 'secondaryOutcomes': [{'measure': 'Difference in Heart Rate [Beats per minute]', 'timeFrame': '15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)', 'description': 'Assess above performance parameters in CPX and compare between Music and Non-Music arm'}, {'measure': 'Difference in O2 Pulse [ml]', 'timeFrame': '15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)', 'description': 'Assess above performance parameters in CPX and compare between Music and Non-Music arm'}, {'measure': 'Difference in Systolic and Diastolic Blood Pressure [mmHg]', 'timeFrame': '15 minutes (at baseline 8 breaths, Anaerobic Threshold 8 breaths, Peak 8 Breaths)', 'description': 'Assess above performance parameters in CPX and compare between Music and Non-Music arm'}, {'measure': 'Difference in Exercise time [mm:ss]', 'timeFrame': '15 minutes (Start to end of CPX study)', 'description': 'Compare the CPX parameter between Music and Non-Music Arm'}, {'measure': 'Difference in Work rate [watt]', 'timeFrame': '15 minutes (Start to end of each CPX study)', 'description': 'Compare the CPX parameter between Music and Non-Music Arm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiopulmonary stress test', 'Exercise stress test', 'Cardiology', 'Exercise performance', 'Heart failure'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The study aims to assess the effect of music on the heart resulting in a change in their exercise capacity among systolic heart failure patients undergoing Cardiopulmonary Exercise testing.', 'detailedDescription': "Studies have previously shown the positive impact of music on the autonomic nervous system, neurohormonal and cardiovascular system. In addition, a previously published study found a positive impact of music resulting in an improvement of quality of life (QOL) in heart failure patients. Proposed mechanisms of benefit of music in heart failure include a reduction in sympathetic activity, and modulation of parasympathetic activity. Further, reduction in anxiety and arterial relaxation are thought to be beneficial effects of music. It is hypothesized that heart failure patients listening to music would have better exercise stress test performance and increased exercise time.\n\nAdult patients with systolic heart failure scheduled to undergo Cardiopulmonary Exercise (CPX) testing at the Gill Heart and Vascular Institute will be recruited.\n\nWhile the patients are undergoing Cardiopulmonary exercise testing, patients randomized to the 'music arm' will listen to pre-selected upbeat music during their duration of the exercise testing via headphones that will be provided to patients by the study personnel. The patients who are randomized to 'non-music arm' in which their headphones will not play music and the patients will perform the cardiopulmonary exercise testing as usual.\n\nStandard clinical care is performing cardiopulmonary exercise testing without any music.\n\nThe investigators will then compare the results of CPX study of the two arms to assess the impact of music on exercise performance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (age \\>18 years)\n* Able to consent\n* English speaking\n\nExclusion Criteria:\n\n* Severe hearing deficiency\n* Unable to exercise.'}, 'identificationModule': {'nctId': 'NCT05537467', 'acronym': 'MUSIC-CPX', 'briefTitle': 'Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Effect of Music on Cardiopulmonary Exercise Capacity in Heart Failure Patients', 'orgStudyIdInfo': {'id': '76503'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music', 'description': 'Music arm will listen to pre-selected music during their duration of the exercise testing via headphones that will be provided to the patients by the study personnel.', 'interventionNames': ['Other: Music']}, {'type': 'NO_INTERVENTION', 'label': 'Non-music', 'description': 'Non-music arm will not have pre-selected music playing during their duration of the exercise testing via the headphones provided to the patients by the study personnel.'}], 'interventions': [{'name': 'Music', 'type': 'OTHER', 'description': 'Patients randomized to the music group will listen to upbeat music using headphones.', 'armGroupLabels': ['Music']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peggy J Hardesty, APRN, MSN', 'role': 'CONTACT', 'email': 'peggy.hardesty@uky.edu', 'phone': '859-323-0295'}, {'name': 'Jennifer R Isaacs, MS, MS', 'role': 'CONTACT', 'email': 'jennifer.isaacs@uky.edu', 'phone': '859-323-4738'}, {'name': 'Maya T Ignaszewski, MD', 'role': 'CONTACT'}], 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'centralContacts': [{'name': 'Peggy J Hardesty, APRN, MSN', 'role': 'CONTACT', 'email': 'peggy.hardesty@uky.edu', 'phone': '859-323-0295'}, {'name': 'Jennifer R Isaacs, MS, MS', 'role': 'CONTACT', 'email': 'jennifer.isaacs@uky.edu', 'phone': '859-323-4738'}], 'overallOfficials': [{'name': 'Maya T Ignaszewski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maya Ignaszewski', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Maya Ignaszewski', 'investigatorAffiliation': 'University of Kentucky'}}}}