Cossu Giulia, Kalcev Goce, Primavera Diego, Lorrai Stefano, Perra Alessandra, Galetti Alessia, Demontis Roberto, Tramontano Enzo, Bert Fabrizio, Montisci Roberta, Maleci Alberto, Castilla Pedro José Fragoso, Jaramillo Shellsyn Giraldo, Kurotschka Peter K, Rocha Nuno Barbosa, Carta Mauro Giovanni
Department of Medical Sciences and Public Health, University of Cagliari, 09124 Cagliari, Italy.
Department of Life and Environmental Sciences, University of Cagliari, 09124 Cagliari, Italy.
J Clin Med. 2025 Jul 29;14(15):5363. doi: 10.3390/jcm14155363.
Emerging 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 (HRV-BF) 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 (). 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, = 0.043). When considering all outcomes collectively, a tendency toward improvement was detected in the experimental group (binomial test, < 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.
新出现的证据表明，一些从新冠病毒疾病（COVID-19）中康复的个体出现了持续症状，包括疲劳、疼痛、认知困难和心理困扰，即通常所说的“长新冠”。这些症状常常与慢性疲劳综合征/肌痛性脑脊髓炎（CFS/ME）的症状重叠，这凸显了综合非药物干预措施的必要性。这项II期对照试验旨在评估心率变异性生物反馈（HRV-BF）对符合CFS/ME诊断标准的长新冠个体的可行性和初步疗效。具体目标包括评估可行性指标（脱落率、副作用、参与者满意度）以及疲劳、抑郁、焦虑、疼痛和健康相关生活质量的变化。参与者按照预先定义的1:1顺序交替且连续地被分配到HRV-BF干预组或常规治疗（TAU）组。干预包括10次HRV-BF疗程，在5周内每周进行两次，每次疗程包括10分钟的呼吸准备和40分钟的主动训练。总体脱落率较低（5.56%），参与者报告的满意度普遍较高。关于副作用，模拟器晕动病问卷的平均总分是24.31（标准差 = 35.42），在排除一个异常值后降至12.82（标准差 = 15.24）。实验组在严重疲劳方面有显著更大的改善（H = 4.083，P = 0.043）。综合考虑所有结果时，实验组呈现出改善的趋势（二项式检验，P < 0.0001）。HRV-BF似乎可行且耐受性良好。研究结果支持进行III期试验以确认其在减轻长新冠疲劳方面的潜力。
