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The use of heart rate variability-biofeedback (HRV-BF) as an adjunctive intervention in chronic fatigue syndrome (CSF/ME) in long COVID: Results of a phase II controlled feasibility trial

2025-07-29Journal article Open access
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dc.contributor.authorCossu, Giulia
dc.contributor.authorKalcev, Goce
dc.contributor.authorPrimavera, Diego
dc.contributor.authorLorrai, Stefano
dc.contributor.authorPerra, Alessandra
dc.contributor.authorGaletti, Alessia
dc.contributor.authorDemontis, Roberto
dc.contributor.authorTramontano, Enzo
dc.contributor.authorBert, Fabrizio
dc.contributor.authorMontisci, Roberta
dc.contributor.authorMaleci, Alberto
dc.contributor.authorCastilla, Pedro José Fragoso
dc.contributor.authorJaramillo, Shellsyn Giraldo
dc.contributor.authorKurotschka, Peter K.
dc.contributor.authorRocha, Nuno Barbosa
dc.contributor.authorCarta, Mauro Giovanni
dc.contributor.authorRocha, Nuno
dc.date.accessioned2025-12-15T15:56:39Z
dc.date.available2025-12-15T15:56:39Z
dc.date.issued2025-07-29
dc.description.abstractEmerging evidence indicates that some individuals recovering from COVID-19 develop persistent symptoms, including fatigue, pain, cognitive difficulties, and psychological distress, commonly known as Long COVID. These symptoms often overlap with those seen in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME), underscoring the need for integrative, non-pharmacological interventions. This Phase II controlled trial aimed to evaluate the feasibility and preliminary efficacy of Heart Rate Variability Biofeedback (HRVBF) in individuals with Long COVID who meet the diagnostic criteria for CFS/ME. Specific objectives included assessing feasibility indicators (drop-out rates, side effects, participant satisfaction) and changes in fatigue, depression, anxiety, pain, and health-related quality of life. Participants were assigned alternately and consecutively to the HRV-BF intervention or Treatment-as-usual (TAU), in a predefined 1:1 sequence (quasirandom assignment). The intervention consisted of 10 HRV-BF sessions, held twice weekly over 5 weeks, with each session including a 10 min respiratory preparation and 40 min of active training. The overall drop-out rate was low (5.56%), and participants reported a generally high level of satisfaction. Regarding side effects, the mean total Simulator Sickness Questionnaire score was 24.31 (SD = 35.42), decreasing to 12.82 (SD = 15.24) after excluding an outlier. A significantly greater improvement in severe fatigue was observed in the experimental group (H = 4.083, p = 0.043). When considering all outcomes collectively, a tendency toward improvement was detected in the experimental group (binomial test, p < 0.0001). HRV-BF appears feasible and well tolerated. Findings support the need for Phase III trials to confirm its potential in mitigating fatigue in Long COVID.eng
dc.description.sponsorshipPNRR—PE13 INF-ACT PE00000007
dc.identifier.citationCossu, G., Kalcev, G., Primavera, D., Lorrai, S., Perra, A., Galetti, A., Demontis, R., Tramontano, E., Bert, F., Montisci, R., Maleci, A., Castilla, P. J. F., Jaramillo, S. G., Kurotschka, P. K., Rocha, N. B., & Carta, M. G. (2025). The use of heart rate variability-biofeedback (HRV-BF) as an adjunctive intervention in chronic fatigue syndrome (CSF/ME) in long COVID: Results of a phase II controlled feasibility trial. Journal of Clinical Medicine, 14(15), 5363. https://doi.org/10.3390/jcm14155363
dc.identifier.doi10.3390/jcm14155363
dc.identifier.eissn2077-0383
dc.identifier.urihttp://hdl.handle.net/10400.22/31206
dc.language.isoeng
dc.peerreviewedyes
dc.publisherMDPI
dc.relation.hasversionhttps://www.mdpi.com/2077-0383/14/15/5363
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectHeart rate variability biofeedback (HRV-BF)
dc.subjectLong COVID
dc.subjectChronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)
dc.subjectFeasibility study
dc.titleThe use of heart rate variability-biofeedback (HRV-BF) as an adjunctive intervention in chronic fatigue syndrome (CSF/ME) in long COVID: Results of a phase II controlled feasibility trialpor
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue15
oaire.citation.titleJournal of Clinical Medicine
oaire.citation.volume14
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85
person.familyNameRocha
person.givenNameNuno
person.identifier192266
person.identifier.ciencia-idAE16-A494-5F8B
person.identifier.orcid0000-0002-3139-2786
person.identifier.ridM-9821-2013
person.identifier.scopus-author-id32867975300
relation.isAuthorOfPublication9e940914-601a-4978-8d5b-74e5ade7ada7
relation.isAuthorOfPublication.latestForDiscovery9e940914-601a-4978-8d5b-74e5ade7ada7

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