Key result
Heart rate variability biofeedback proves feasible and improves severe fatigue over treatment as usual.
Why the study?
Long COVID symptoms often overlap with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, underscoring the need for integrative, non-pharmacological interventions.
Does Heart Rate Variability Biofeedback improve fatigue and feasibility outcomes in individuals with Long COVID and CFS/ME?
RCT
Quasirandom assignment (1:1 sequence)
Does Heart Rate Variability Biofeedback improve fatigue and feasibility outcomes in individuals with Long COVID and CFS/ME?
p-value: p=0.043
Heart Rate Variability Biofeedback is a feasible and well-tolerated adjunctive intervention that may improve severe fatigue in patients with Long COVID and CFS/ME.
Supports HRV biofeedback for severe fatigue in Long COVID/CFS/ME; extends RCT evidence for nonpharmacologic adjuncts.
Background: 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. Methods: 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. Results: 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). Conclusions: 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.
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Cossu et al. (2025) conducted an RCT in Long COVID with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). Heart Rate Variability Biofeedback (HRV-BF) vs. Treatment-as-usual (TAU) was evaluated on Feasibility indicators (drop-out rates, side effects, participant satisfaction) and changes in fatigue, depression, anxiety, pain, and health-related quality of life (p=0.043). Heart Rate Variability Biofeedback was feasible, well-tolerated, and associated with a significantly greater improvement in severe fatigue compared to treatment-as-usual (p=0.043).
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