REVIVE-HF: study protocol for a randomized controlled trial of immersive virtual reality-augmented aerobic exercise in hospitalized patients with heart failure

REVIVE-HF: study protocol for a randomized controlled trial of immersive virtual reality-augmented aerobic exercise in hospitalized patients with heart failure | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article REVIVE-HF: study protocol for a randomized controlled trial of immersive virtual reality-augmented aerobic exercise in hospitalized patients with heart failure Ariele dos Santos Costa, Caroline Bublitz Barbosa, Solange Guizilini, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7547188/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 28 Jan, 2026 Read the published version in Trials → Version 1 posted 5 You are reading this latest preprint version Abstract Background Heart failure (HF) is characterized by exercise intolerance, which results in poor quality of life. Supervised aerobic exercise is central to cardiac rehabilitation, but tolerance and adherence may be hindered by physical and motivational barriers. Immersive virtual reality (VR) may enhance engagement during exercise. Methods This was a parallel-group randomized controlled trial (1:1, no stratification). Hemodynamically stable adults hospitalized with decompensated HF will complete a single supervised cycle-ergometer session seated in a hospital armchair: five 3-min pedaling blocks with 1-min rests (early termination per safety/symptom criteria). Groups: control (exercise only) vs intervention (same exercise delivered with VZfit on a Meta Quest 2 headset). The primary endpoint was effective exercise time (minutes) = cumulative pedaling time (scheduled rests excluded) to termination due to symptoms or predefined safety thresholds. The secondary endpoints were as follows: block-level hemodynamics (SBP/DBP, HR, RR, SpO₂), the rating of perceived exertion (RPE; modified Borg 0–10), PACES (between-group), and the SUS (VR arm only). The outcome assessors and data analysts will be blinded. Discussion This trial tests whether VR increases exercise tolerance during HF hospitalization and may inform the integration of VR into inpatient cardiac rehabilitation. Trial registration: Brazilian Clinical Trials Registry (ReBEC), RBR-4hrmkzz, registered on March 11, 2022. virtual reality heart failure rehabilitation usability satisfaction Full Text Supplementary Files SPIRIT2025.docx Cite Share Download PDF Status: Published Journal Publication published 28 Jan, 2026 Read the published version in Trials → Version 1 posted Editorial decision: Minor revision 26 Oct, 2025 Reviewers agreed at journal 17 Sep, 2025 Reviewers invited by journal 17 Sep, 2025 Editor assigned by journal 09 Sep, 2025 First submitted to journal 08 Sep, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7547188","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":516303516,"identity":"e72d32a4-6ab8-4d0a-8b6b-ad1cb473bcd8","order_by":0,"name":"Ariele dos Santos 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reality, heart failure, rehabilitation, usability, satisfaction","lastPublishedDoi":"10.21203/rs.3.rs-7547188/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7547188/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003eHeart failure (HF) is characterized by exercise intolerance, which results in poor quality of life. Supervised aerobic exercise is central to cardiac rehabilitation, but tolerance and adherence may be hindered by physical and motivational barriers. Immersive virtual reality (VR) may enhance engagement during exercise.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eThis was a parallel-group randomized controlled trial (1:1, no stratification). Hemodynamically stable adults hospitalized with decompensated HF will complete a single supervised cycle-ergometer session seated in a hospital armchair: five 3-min pedaling blocks with 1-min rests (early termination per safety/symptom criteria). Groups: control (exercise only) vs intervention (same exercise delivered with VZfit on a Meta Quest 2 headset). The primary endpoint was effective exercise time (minutes)\u0026thinsp;=\u0026thinsp;cumulative pedaling time (scheduled rests excluded) to termination due to symptoms or predefined safety thresholds. The secondary endpoints were as follows: block-level hemodynamics (SBP/DBP, HR, RR, SpO₂), the rating of perceived exertion (RPE; modified Borg 0\u0026ndash;10), PACES (between-group), and the SUS (VR arm only). The outcome assessors and data analysts will be blinded.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e\u003cp\u003eThis trial tests whether VR increases exercise tolerance during HF hospitalization and may inform the integration of VR into inpatient cardiac rehabilitation.\u003c/p\u003e\u003ch2\u003eTrial registration:\u003c/h2\u003e\u003cp\u003eBrazilian Clinical Trials Registry (ReBEC), RBR-4hrmkzz, registered on March 11, 2022.\u003c/p\u003e","manuscriptTitle":"REVIVE-HF: study protocol for a randomized controlled trial of immersive virtual reality-augmented aerobic exercise in hospitalized patients with heart failure","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-25 14:46:47","doi":"10.21203/rs.3.rs-7547188/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Minor revision","date":"2025-10-26T05:30:44+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2025-09-17T13:20:39+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-09-17T06:28:42+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-09-09T11:08:24+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2025-09-08T19:29:09+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"27e3c6d4-242c-400c-9eb9-83616d036956","owner":[],"postedDate":"September 25th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-02-02T16:15:22+00:00","versionOfRecord":{"articleIdentity":"rs-7547188","link":"https://doi.org/10.1186/s13063-026-09430-y","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2026-01-28 15:58:58","publishedOnDateReadable":"January 28th, 2026"},"versionCreatedAt":"2025-09-25 14:46:47","video":"","vorDoi":"10.1186/s13063-026-09430-y","vorDoiUrl":"https://doi.org/10.1186/s13063-026-09430-y","workflowStages":[]},"version":"v1","identity":"rs-7547188","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7547188","identity":"rs-7547188","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}