Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-02-26 @ 5:41 PM
Study NCT ID:
NCT05596292
Status:
UNKNOWN
Last Update Posted:
2022-12-05
First Post:
2022-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensation of Dyspnea and Experience of Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center randomized parallel controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-01', 'studyFirstSubmitDate': '2022-10-07', 'studyFirstSubmitQcDate': '2022-10-25', 'lastUpdatePostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline sensation of dyspnea on the Borg Rating Of Perceived Exertion Scale at immediately post-intervention', 'timeFrame': 'Up to 3 minutes before and up to 3 minutes after the early mobilization protocol with and without immersive virtual reality', 'description': 'The evaluation of dyspnea sensation using the Borg Rating Of Perceived Exertion Scale. This scale has a score ranging from zero to 10, and the higher the score the patient reports, the greater the sensation of dyspnea'}], 'secondaryOutcomes': [{'measure': 'Patient experience with and without immersive virtual reality during mobilization', 'timeFrame': 'Within 48 hours after the end of the early mobilization protocol with and without immersive virtual reality', 'description': 'Assessment of patient experience using the Net Promoter Score, Likert and Analogical Scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early Mobilization', 'Cardiac Rehabilitation', 'Virtual reality', 'Exercise Tolerance', 'Patient experience'], 'conditions': ['Decompensated Heart Failure']}, 'referencesModule': {'references': [{'pmid': '40955916', 'type': 'DERIVED', 'citation': 'Caballero LG, Fraga IB, Tremea CEM, Perin G, Prates JDS, Lago PD, Oliveira JLC, Rabelo-Silva ER. Experience of heart failure patients in mobilization with virtual reality: mixed methods study. Rev Esc Enferm USP. 2025 Sep 15;59:e20250114. doi: 10.1590/1980-220X-REEUSP-2025-0114en. eCollection 2025.'}, {'pmid': '38001540', 'type': 'DERIVED', 'citation': 'Fraga IB, Caballero LG, Lago PD, de Oliveira JLC, Scherer M, Haeffner MP, Rabelo-Silva ER. Perceived dyspnea and experience of hospitalized patients with acute decompensated heart failure undergoing an early MObilization protocol with immersive Virtual rEality: MOVE study protocol for a parallel superiority randomized clinical trial. Trials. 2023 Nov 24;24(1):751. doi: 10.1186/s13063-023-07786-z.'}]}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial aims to evaluate patients with decompensated heart failure undergoing an early mobilization protocol with the use of immersive virtual reality glasses compared with patients undergoing the same protocol but without immersive virtual reality. The primary outcome will be the sensation of difficulty breathing, and the secondary outcome will be whether this technology provided a positive experience for patients in the intervention group that was superior to that of patients in the control group.', 'detailedDescription': 'This randomized clinical trial aims to assess the sensation of dyspnea in patients undergoing an early mobilization protocol with immersive virtual reality and their experience using this technology. The study population consists of patients with acute decompensated heart failure in an intensive care unit at a teaching hospital. The 3-day protocol will include active exercises with an in-bed cycle ergometer, orthostasis, and ambulation. The intervention group will perform all exercises using virtual reality glasses. The variables will be collected before and after each intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria - Patients with 18 years or older\n\n* Being hospitalized for 24 hours or more\n* Diagnosis of acute heart failure decompensated\n* Being lucid and colaborative\n\nExclusion Criteria:\n\n* Mechanical ventilation or circulatory support\n* Neurodegenerative diseases\n* Pregnant patients\n* Hemodynamic instability at baseline\n* Score on the Borg Rating of Perceived Exertion Scale Borg ≥ 4 at rest\n* High risk of falls\n* Difficulty communicating\n* Not adapt with the immersive virtual reality glasses'}, 'identificationModule': {'nctId': 'NCT05596292', 'acronym': 'MOVE', 'briefTitle': 'Sensation of Dyspnea and Experience of Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Sensation of Dyspnea and Experience of Patients With Decompensated Heart Failure Undergoing an Early Mobilization Protocol With Immersive Virtual Reality: a Clinical Trial Protocol', 'orgStudyIdInfo': {'id': '2022-0355'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'early mobilization protocol and immersive virtual reality', 'description': "Three days of an early mobilization protocol using immersive virtual reality glasses. The exercises will be progressed every day, starting in the first day with active movements of lower and upper limbs with cycle ergometer; in the second day repeat the first day exercise and do orthostasis training; and in the last day training ambulation. The immersive virtual reality glasses support a smartphone device, allowing videos to be used with 360º rotation and earpods headphones with bluetooth for sound. Video options will be offered to participants according to the exercise performed, ie: a cycling video for activities with a cycle ergometer; video with people walking for ambulation; and videos of the patient's choice, such as forest, beach or city scenarios, for other moments.", 'interventionNames': ['Device: Immersive Virtual Reality glasses', 'Other: early mobilization protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'early mobilization protocol', 'description': 'Three days of an early mobilization protocol. The exercises will be progressed every day, starting in the first day with active movements of lower and upper limbs with cycle ergometer; in the second day repeat the first day exercise and do orthostasis training; and in the last day training ambulation.', 'interventionNames': ['Other: early mobilization protocol']}], 'interventions': [{'name': 'Immersive Virtual Reality glasses', 'type': 'DEVICE', 'description': "The immersive virtual reality glasses support a smartphone device, allowing videos to be used with 360º rotation and earpods headphones with bluetooth for sound. Video options will be offered to participants according to the exercise performed, ie: a cycling video for activities with a cycle ergometer; video with people walking for ambulation; and videos of the patient's choice, such as forest, beach or city scenarios, for other moments.", 'armGroupLabels': ['early mobilization protocol and immersive virtual reality']}, {'name': 'early mobilization protocol', 'type': 'OTHER', 'description': 'Three days of an early mobilization protocol. The exercises will be progressed every day, starting in the first day with active movements of lower and upper limbs with cycle ergometer; in the second day repeat the first day exercise and do orthostasis training; and in the last day training ambulation.', 'armGroupLabels': ['early mobilization protocol', 'early mobilization protocol and immersive virtual reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035003', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Eneida R Rabelo da Silva, Professor', 'role': 'CONTACT', 'email': 'eneidarabelo@gmail.com', 'phone': '55 51 33598084'}, {'name': 'Eneida R Rabelo da Silva, RN,ScD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pedro D Lago, ScD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'João Lucas C Oliveira, RN,ScD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Larissa G Caballero, RN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Iasmin B Fraga', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mauren P Haeffner', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marina S Santos, RN', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital de Clinicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Eneida R Rabelo Silva, RN, MSc,ScD', 'role': 'CONTACT', 'email': 'eneidarabelo@gmail.com', 'phone': '55 51998068616'}], 'overallOfficials': [{'name': 'Eneida R Rabelo Silva, RN, MSc, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Rio Grande do Sul'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Study Protocol when published', 'ipdSharing': 'YES', 'description': 'Mobilization and experience data', 'accessCriteria': 'When available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federal University of Rio Grande do Sul', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}