Normative value of deep neck flexors muscle strength measurement using pressure biofeedback unit and sphygmomanometer: An observational study.

PURPOSE: To find out the normative value of deep neck flexor muscles strength using pressure biofeedback unit and sphygmomanometer. METHODS: The healthy individuals both male and female aged between 18 and 25 years were recruited by stratified random sampling method from a tertiary hospital. The procedure is performed with the patient in supine lying with the neck in a neutral position. To check strength, pressure biofeedback unit and sphygmomanometer were placed under occiput and ask the individual to do the movement is genteelly and slowly as a head nodding action (chin tuck). The performance was scored via the pressure level that patient achieves 3 repetitions for 10 s hold and interval timing for 10 s. And the pressure biofeedback unit and sphygmomanometer inflated with 40 mmHg and took three reading respectively. RESULT: Our result shows, in decreased of deep neck cervical flexor muscle Strength with age group 21 (20-22) in normal adult and underweight with age group 21 (19-23) and with BMI 21 (20.1-22.4) and 16.6 (16.1-17.6) respectively. In our study, the deep neck flexor strength of overweight adults with age group 22 (21-23) and with BMI 27.8 (25.9-29.4) is stronger is than the normal and underweight adults. CONCLUSION: The study concluded that the maximal Deep neck cervical flexor strength of overweight Adults is stronger than normal and underweight Adults. The difference is maintained in all age groups. The maximal Deep neck cervical flexor strength, for flexion is developed at neutral position of neck.

Practice effects of a breathing technique on pilots' cognitive and stress associated heart rate variability during flight operations.

Commercial pilots endure multiple stressors in their daily and occupational lives which are detrimental to psychological well-being and cognitive functioning. The Quick coherence technique (QCT) is an effective intervention tool to improve stress resilience and psychophysiological balance based on a five-minute paced breathing exercise with heart rate variability (HRV) biofeedback. The current research reports on the application of QCT training within an international airline to improve commercial pilots' psychological health and support cognitive functions. Forty-four commercial pilots volunteered in a one-month training programme to practise self-regulated QCT in day-to-day life and flight operations. Pilots' stress index, HRV time-domain and frequency-domain parameters were collected to examine the influence of QCT practice on the stress resilience process. The results demonstrated that the QCT improved psychophysiological indicators associated with stress resilience and cognitive functions, in both day-to-day life and flight operation settings. HRV fluctuations, as measured through changes in RMSSD and LF/HF, revealed that the resilience processes were primarily controlled by the sympathetic nervous system activities that are important in promoting pilots' energy mobilization and cognitive functions, thus QCT has huge potential in facilitating flight performance and aviation safety. These findings provide scientific evidence for implementing QCT as an effective mental support programme and controlled rest strategy to improve pilots' psychological health, stress management, and operational performance.

The effect of duration between sessions on microperimetric biofeedback training in patients with maculopathies.

Aim of this study was to explore the optimal training interval and times of microperimetric biofeedback training (MBFT) in maculopathies. Twenty-nine patients with maculopathies were divided into two groups: daily training (Group A) or alternate daily training (Group B). Both groups underwent 15 MBFT sessions. We compared the BCVA, reading speed, and fixation stability at baseline, after 5, 10, 15 sessions. After 15 sessions of MBFT, all visual parameters in both groups improved. There was a significant increase in BCVA after 5 sessions in both groups (P=0.016, and P<0.001 respectively), but Group A showed further improvement after 10 sessions (P<0.001). Regarding reading speed, Group A showed significant improvement from baseline after 15 sessions(P=0.020), Group B improved significantly after 5 sessions (P=0.047) and continued to improve after 10 sessions (P=0.030). Additionally, P1 and LgBCEA of Group A significantly improved after 10 sessions (P=0.001, and P=0.001 respectively), while Group B significantly improved after 5 sessions (P=0.002, and P<0.001 respectively). There was no significant difference in visual outcomes between the two groups (P>0.05) except LgBCEA (P=0.046) after 15 sessions. We concluded that the both MBFT frequencies are effective at improving vision and quality of life in patients with maculopathies. The alternate daily training group showed less time-dependent of improvement in all parameters and a greater benefit in fixation stability. Ten sessions are the optimal number of treatment sessions for alternate daily training.

The effectiveness of core stabilization exercise using ultrasound biofeedback on motor function, balance control, gait speed and activities of daily living in stroke patients.

BACKGROUND: Patients with hemiparetic stroke experience diminished motor function, dynamic balance, and gait speed, which influence their activities of daily living (ADL). OBJECTIVE: This study aimed to determine the therapeutic effects of ultrasound biofeedback core exercise (UBCE) on Fugl-Meyer assessment (FMA), Time up and go (TUG), 10-meter walking test (10MWT) and functional independent measure (FIM) in participants with stroke. METHODS: Twenty-four stroke survivors consistently underwent UBCE or abdominal draw-in maneuver (ADIM) for 30 min/session, 3 days a week for 4 weeks. Clinical outcome measurements - the FMA, TUG, 10MWT, and FIM - were observed pre-and post-intervention. RESULTS: We detected significant changes in the FMA-lower extremities, TUG, 10MWT, and FIM scores between the UBCE and ADIM groups. UBCE and ADIM showed significant improvements in FMA-lower extremities, TUG, 10MWT, and FIM scores. However, UBCE showed more favorable results than ADIM in patients with stroke. CONCLUSIONS: Our research provides novel therapeutic suggestion of neurorehabilitation in stroke patients.

The Validity and Reliability of a Real-Time Biofeedback System for Lumbopelvic Control Training in Baseball Players.

BACKGROUND: This study validates real-time biofeedback for lumbopelvic control training in baseball. The lumbopelvic region is crucial for generating kinetic energy in pitching. Real-time biofeedback enhances training effectiveness and reduces injury risk. The validity and reliability of this system were examined. PURPOSE: This study was to investigate the validity and reliability of the real-time biofeedback system for lumbopelvic control training. METHODS: Twelve baseball players participated in this study, with data collected in two sessions separated by a week. All participants needed to do the lateral slide exercise and single-leg squat exercise in each session. Pelvic angles detected by the real-time biofeedback system were compared to the three-dimensional motion capture system (VICON) during training sessions. Additionally, pelvic angles measured by the biofeedback system were compared between the two training sessions. RESULTS: The real-time biofeedback system exhibited moderate to strong correlations with VICON in both exercises: lateral slide exercise (r = 0.66-0.88, p < 0.05) and single-leg squat exercise (r = 0.70-0.85, p < 0.05). Good to excellent reliability was observed between the first and second sessions for both exercises: lateral slide exercise (ICC = 0.76-0.97) and single-leg squat exercise (ICC = 0.79-0.90). CONCLUSIONS: The real-time biofeedback system for lumbopelvic control training, accurately providing the correct pelvic angle during training, could enhance training effectiveness.

Nonpharmacologic Treatment of Chronic Constipation.

Functional constipation is a common clinical diagnosis that affects approximately 14% of the world's population. Non-pharmacological therapies often represent the initial steps in management and may include lifestyle adjustments or changes such as physical activity and diet. Pharmacological options have been used when the non-pharmacological approach has been ineffective. Biofeedback therapy, surgery, sacral nerve stimulation, botulinum toxin injection, and vibrating capsules can be considered in scenarios where the laxatives are ineffective. Biofeedback therapy is highly effective and safe in treating dyssynergic defecation, which affects more than half of patients with chronic constipation. This paper overviews non-pharmacological therapies for functional constipation.

The immediate efficacy of the spinomed orthosis and biofeedback posture orthosis on balance and gait in older people with thoracic hyperkyphosis.

BACKGROUND: Increased kyphosis is a common condition among older people that may, directly or indirectly, be a risk factor for poor balance and gait. Spinomed and Biofeedback Posture Trainer (BPT) orthoses is an effective treatment approach for hyperkyphosis. This study aimed to compare the immediate effects of the Spinomed and BPT orthoses on balance and gait in the older population. METHODS: A total of 52 volunteer older people with hyperkyphosis (kyphosis angle>40°) participated in this study and were randomly allocated into two groups, to either the Spinomed orthosis (n = 26, mean age = 65.50 ± 5.50) or the BPT (n = 26, mean age = 65.38 ± 5.69) orthosis. All participants were asked to wear the orthoses for 1.5 h to get used to them. Balance parameters, which are Postural Stability Test (PST), Limits of Stability (LOS), and Clinical Test of Sensory Integration for Balance (m-CTSIB) were assessed using the Biodex Balance System, while walking parameters were assessed using the G-Walk with and without orthosis. RESULTS: The Spinomed had a positive effect on balance parameters (p < 0.05) except for the closed eyes firm surface and the opened eyes foam surface conditions of the m-CTSIB (p > 0.05). BPT had a significant impact on the PST score, LOS, and the closed eyes firm surface condition of the m-CTSIB (p < 0.001). Spinomed had a significant effect on cadence, speed, gait cycle duration, elaborated steps, and symmetry index of pelvic angles (p < 0.05), while the BPT had a significant effect only on step length and rotation symmetry index. No significant difference was detected between the two types of orthoses in the balance and gait parameters (p > 0.05). CONCLUSIONS: Spinomed and BPT were both effective in improving balance performance, with similar improvements demonstrated by both orthoses. Additionally, Spinomed may provide significant improvements in cadence, speed, gait cycle duration, elaborated steps, and all symmetry indexes of pelvic angles in the short term.

DistaNet: grasp-specific distance biofeedback promotes the retention of myoelectric skills.

Objective.An active myoelectric interface responds to the user's muscle signals to enable movements. Machine learning can decode user intentions from myoelectric signals. However, machine learning-based interface control lacks continuous, intuitive feedback about task performance, needed to facilitate the acquisition and retention of myoelectric control skills.Approach.We propose DistaNet as a neural network-based framework that extracts smooth, continuous, and low-dimensional signatures of the hand grasps from multi-channel myoelectric signals and provides grasp-specific biofeedback to the users.Main results.Experimental results show its effectiveness in decoding user gestures and providing biofeedback, helping users retain the acquired motor skills.Significance.We demonstrates myoelectric skill retention in a pattern recognition setting for the first time.

Temporomandibular Joint Disorder: An integrated study of the pathophysiology, neural mechanisms, and therapeutic strategies.

OBJECTIVE: The study aims to investigate Temporomandibular Joint Disorder (TMJD) through a interdisciplinary lens, integrating insights from neuroscience, dentistry, and psychology to dissect its complex pathophysiology and neural mechanisms. It focuses on exploring the neurobiological underpinnings of TMJD, emphasizing the role of pain perception, modulation, and the impact of neurophysiological changes on the disorder. DESIGN: This is a comprehensive narrative review of the literature. RESULTS: Research findings pinpoint altered pain perception and modulation processes as central neural mechanisms contributing to TMJD, highlighting the importance of personalized treatment approaches due to the disorder's complexity and patient variability. The study recognizes advances in neuroscience offering new treatment avenues, such as neuromodulation and biofeedback, which provide non-invasive and personalized options. However, it also addresses the challenges in TMJD research, such as the multifaceted nature of the disorder and the need for more comprehensive, interdisciplinary strategies in research and clinical practice. CONCLUSIONS: TMJD is a multifaceted disorder requiring an interdisciplinary approach for effective management. The study stresses the crucial role of neuroscience in understanding and treating TMJD, facilitating the development of innovative treatment strategies. It emphasizes the need for further research, advocating an integrated approach that combines neuroscience, dentistry, and psychology to address TMJD's complexities comprehensively and improve patient care, thereby enhancing the quality of life for affected individuals.

The effect of a biofeedback-based virtual reality game on pain, fear and anxiety levels during port catheter needle insertion in pediatric oncology patients: A randomized controlled study.

PURPOSE: It is essential to control pain, fear, and anxiety related to medical procedures to improve the well-being of the child and family trying to cope with the disease process. This study investigated the impact of the biofeedback-based virtual reality game (BioVirtualPed) on pain, fear, and anxiety levels during port needle insertion in pediatric oncology patients (POPs). METHODS: This randomized controlled study was conducted at a hospital between August and December 2023 involving 62 POPs aged 6-12 and their mothers. The intervention group wore a virtual reality headset and a respiratory sensor during the procedure. Data were collected using the Descriptive Information Form, Wong-Baker Pain Assessment Scale, Child Fear Scale, Children's State Anxiety, Satisfaction Scoring-Visual Analog Scale, and ADXL354 Sensor. Statistical analysis was performed using IBM SPSS for Windows Version 24.0. RESULTS: The intervention group showed lower mean pain scores than the control group (p < 0.001). There was no difference in pre-procedure fear and anxiety scores between groups (p > 0.05 and p > 0.05, respectively). Post-procedure fear and anxiety scores were lower in the intervention group (p < 0.001 and p < 0.001, respectively). The intervention group's mean respiratory rates were lower (p < 0.001), and their satisfaction scores were higher (p < 0.001). Agreements between POPs and mothers on pain, fear, and anxiety scores were good and excellent across groups (p < 0.001). CONCLUSIONS: The BioVirtualPed reduced procedure-related pain, anxiety, and fear, increased care satisfaction, and had a positive effect on the mean respiratory rate, hence it shows promising results, but these findings need further comfirmation.

[Rehabilitation in bilateral vestibulopathy: trends and perspectives]. / Reabilitatsiya patsientov s dvustoronnei vestibulopatiei: tendentsii i perspektivy razvitiya.

A review of the literature on rehabilitation methods for bilateral vestibulopathy is presented using RSCI, Scopus and PubMed databases. The principles and effectiveness of physical vestibular rehabilitation, vestibular implants, galvanic vestibular stimulation, and biofeedback-based sensory substitution and augmentation systems are described. The advantages and disadvantages of each method and perspectives for their improvement are presented.

Electromyographic biofeedback training in a cerebral palsy patient undergoing pronator teres rerouting and brachioradialis to extensor carpi radialis brevis tendon transfer surgery: A case report.

Several surgical procedures are used to treat dynamic pronation position of the forearm and flexion deformity of the wrist in cerebral palsy. Postoperative results of pronator teres rerouting were explored, while specially designed postoperative physiotherapy and its outcomes were limited. Herein, we present a case in whom the outcomes of electromyographic biofeedback (EMG-BF) training were assessed after pronator teres rerouting and brachioradialis tendon to extensor carpi radialis brevis tendon transfer combined with derotation osteotomy. The peak value increased, while the resting value decreased for the muscles after the intervention. Range of motion, hand function, manual ability, functional independence, and quality of life levels were improved. In conclusion, EMG biofeedback training may have a positive effect on neuromuscular control of pronator teres and brachioradialis. Free use of the upper extremity and improved manual ability positively affect the activity and quality of life of the patients.

Evaluation of the impact of overlapping upper gastrointestinal symptoms on the clinical characteristics of patients with functional constipation, along with risk factor analysis.

OBJECTIVES: Functional constipation (FC), a common functional gastrointestinal disorder, is usually overlapping with upper gastrointestinal symptoms (UGS). We aimed to explore the clinical characteristics of patients with FC overlapping UGS along with the related risk factors. METHODS: The differences in the severity of constipation symptoms, psychological state, quality of life (QoL), anorectal motility and perception function, autonomic function, and the effect of biofeedback therapy (BFT) among patients with FC in different groups were analyzed, along with the risk factors of overlapping UGS. RESULTS: Compared with patients with FC alone, those with FC overlapping UGS had higher scores in the Patient Assessment of Constipation Symptoms and Self-Rating Anxiety Scale and lower scores in the Short Form-36 health survey (P < 0.05). Patients with FC overlapping UGS also had lower rectal propulsion, more negative autonomic nervous function, and worse BFT efficacy (P < 0.05). Overlapping UGS, especially overlapping functional dyspepsia, considerably affected the severity of FC. Logistic regression model showed that age, body mass index (BMI), anxiety, exercise, and sleep quality were independent factors influencing overlapping UGS in patients with FC. CONCLUSIONS: Overlapping UGS reduces the physical and mental health and the QoL of patients with FC. It also increases the difficulty in the treatment of FC. Patient's age, BMI, anxiety, physical exercise, and sleep quality might be predictors for FC overlapping UGS.

[Impact of biofeedback therapy on patients with fecal incontinence or constipation in a gastrointestinal neurophysiology unit in Bogotá, D.C.] / Impacto de la terapia de biorretroalimentación en pacientes con incontinencia fecal o constipación en una unidad de neurofisiología gastrointestinal en Bogotá, D.C.

INTRODUCTION: Treatment of functional disorders of the anorectal unit should focus on the underlying cause. Biofeedback therapy is a functional retraining of the pelvic floor that has proven useful in the treatment of constipation associated with dyssynergia and in the management of fecal incontinence. This study describes the first experiences with this form of biofeedback therapy in Colombia. OBJECTIVE: Describe our experience with biofeedback therapy in the gastrointestinal neurophysiology unit. MATERIALS AND METHODS: This historical cohort included patients with an indication for biofeedback therapy for constipation or fecal incontinence in the gastrointestinal neurophysiology unit during the data collection period. The response to therapy is described by comparing manometricfindings before and after 10 biofeedback sessions. RESULTS: 21 patients were included(71.4% women, the average age was 68, 9 with constipation and 12 with fecal incontinence.Among the patients with constipation there was a significant improvement in 71.4% of those who had rectal hyposensitivity and in 57.1% of those with dyssynergia. Biofeedback therapysignificantly increased the balloon expulsion rate (11.1 vs. 66.7%, p=0.02). In patients with fecal incontinence, there was improvement in 50% of those who had anal hypotonia and in 80% of those who had anal hyposensitivity. CONCLUSIONS: This study demonstrates that biofeedback therapy has a favorable impact on a high number of patients with constipationand fecal incontinence; in our center, the response is similar to that of the world literature.

Learning effects in over-ground running gait retraining: A six-month follow-up of a quasi-randomized controlled trial.

This study evaluated learning and recall effects following a feedback-based retraining program. A 6-month follow-up of a quasi-randomized controlled trial was performed with and without recall. Twenty runners were assigned to experimental or control groups and completed a 3-week running program. A body-worn system collected axial tibial acceleration and provided real-time feedback on peak tibial acceleration for six running sessions in an athletic training facility. The experimental group received music-based biofeedback in a faded feedback scheme. The controls received tempo-synchronized music as a placebo for blinding purposes. The peak tibial acceleration and vertical loading rate of the ground reaction force were determined in a lab at baseline and six months following the intervention to assess retention and recall. The impacts of the experimental group substantially decreased at follow-up following a simple verbal recall (i.e., run as at the end of the program): peak tibial acceleration:-32%, p = 0.018; vertical loading rate:-34%, p = 0.006. No statistically significant changes were found regarding the retention of the impact variables. The impact magnitudes did not change over time in the control group. The biofeedback-based intervention did not induce clear learning at follow-up, however, a substantial impact reduction was recallable through simple cueing in the absence of biofeedback.

Either Autonomy Support or Enhanced Expectancies Delivered Via Virtual-Reality Benefits Frontal-Plane Single-Leg Squatting Kinematics.

Our purpose in this study was to determine the effects of a virtual reality intervention delivering specific motivational motor learning manipulations of either autonomy support (AS) or enhanced expectancies (EE) on frontal plane single-leg squatting kinematics. We allocated 45 participants (21 male, 24 female) demonstrating knee, hip, and trunk frontal plane mechanics associated with elevated anterior cruciate ligament injury risk to one of three groups (control, AS, or EE). Participants mimicked an avatar performing five sets of eight repetitions of exemplary single-leg squats. AS participants were given the added option of choosing the color of their avatar. EE participants received real-time biofeedback in the form of green highlights on the avatar that remained on as long as the participant maintained pre-determined 'safe' frontal plane mechanics. We measured peak frontal plane knee, hip, and trunk angles before (baseline) and immediately following (post) the intervention. The control group demonstrated greater increases in knee abduction angle (Δ = +2.3°) than did the AS (Δ = +0.1°) and EE groups (Δ = -0.4°) (p = .003; η2p = .28). All groups demonstrated increased peak hip adduction (p = .01, ηp2 = .18) (control Δ = +1.5°; AS Δ = +3.2°; EE Δ = +0.7°). Hip adduction worsened in all groups. AS and EE motivation strategies appeared to mitigate maladaptive frontal plane knee mechanics.

A Preliminary Study of Voluntary Cough Motor Performance and Learning With Skill Training and Biofeedback.

PURPOSE: Sensorimotor cough skill training (CST) has been shown to improve cough strength, as well as facilitate changes during training (i.e., motor performance) and generalization to untrained tasks (i.e., motor learning). However, there is a gap in our understanding of the effects of voluntary CST (without sensory stimuli) on motor performance and learning. Furthermore, the contribution of physiologic factors, such as lung volume, a driver of cough strength in healthy adults, and treatment-specific factors, such as biofeedback, remains unexamined. METHOD: Twenty individuals with Parkinson's disease (PD) completed pre- and post-CST single voluntary, sequential voluntary, and reflex cough testing. Participants were randomized to biofeedback or no biofeedback groups. They completed one CST session involving 25 trials of voluntary coughs, with the treatment target set 25% above baseline peak flow. Participants were instructed to "cough hard" to exceed the target. In the biofeedback group, participants received direct visualization of the target line in real time. RESULTS: Cough peak flow showed positive improvements in motor performance (ß = .02; 95% credible interval [CI]: 0.01, 0.03) and learning (ß = .26; 95% CI: 0.03, 0.47). Changes in lung volume from pre- to post-CST did not predict treatment response. No differences in treatment response were detected between the biofeedback groups. CONCLUSIONS: A single session of voluntary CST improved voluntary cough motor performance and learning. Although lung volume increased during CST, changes to lung volume did not predict treatment response. These findings demonstrate the potential of voluntary CST to improve motor performance and motor learning among individuals with PD and cough dysfunction. SUPPLEMENTAL MATERIAL AND OPEN SCIENCE FORM: https://doi.org/10.23641/asha.25447444.

Remote Short Sessions of Heart Rate Variability Biofeedback Monitored With Wearable Technology: Open-Label Prospective Feasibility Study.

BACKGROUND: Heart rate variability (HRV) biofeedback is often performed with structured education, laboratory-based assessments, and practice sessions. It has been shown to improve psychological and physiological function across populations. However, a means to remotely use and monitor this approach would allow for wider use of this technique. Advancements in wearable and digital technology present an opportunity for the widespread application of this approach. OBJECTIVE: The primary aim of the study was to determine the feasibility of fully remote, self-administered short sessions of HRV-directed biofeedback in a diverse population of health care workers (HCWs). The secondary aim was to determine whether a fully remote, HRV-directed biofeedback intervention significantly alters longitudinal HRV over the intervention period, as monitored by wearable devices. The tertiary aim was to estimate the impact of this intervention on metrics of psychological well-being. METHODS: To determine whether remotely implemented short sessions of HRV biofeedback can improve autonomic metrics and psychological well-being, we enrolled HCWs across 7 hospitals in New York City in the United States. They downloaded our study app, watched brief educational videos about HRV biofeedback, and used a well-studied HRV biofeedback program remotely through their smartphone. HRV biofeedback sessions were used for 5 minutes per day for 5 weeks. HCWs were then followed for 12 weeks after the intervention period. Psychological measures were obtained over the study period, and they wore an Apple Watch for at least 7 weeks to monitor the circadian features of HRV. RESULTS: In total, 127 HCWs were enrolled in the study. Overall, only 21 (16.5%) were at least 50% compliant with the HRV biofeedback intervention, representing a small portion of the total sample. This demonstrates that this study design does not feasibly result in adequate rates of compliance with the intervention. Numerical improvement in psychological metrics was observed over the 17-week study period, although it did not reach statistical significance (all P>.05). Using a mixed effect cosinor model, the mean midline-estimating statistic of rhythm (MESOR) of the circadian pattern of the SD of the interbeat interval of normal sinus beats (SDNN), an HRV metric, was observed to increase over the first 4 weeks of the biofeedback intervention in HCWs who were at least 50% compliant. CONCLUSIONS: In conclusion, we found that using brief remote HRV biofeedback sessions and monitoring its physiological effect using wearable devices, in the manner that the study was conducted, was not feasible. This is considering the low compliance rates with the study intervention. We found that remote short sessions of HRV biofeedback demonstrate potential promise in improving autonomic nervous function and warrant further study. Wearable devices can monitor the physiological effects of psychological interventions.

The efficacy of heart rate variability biofeedback training on sleep disorders and impact of fibromyalgia: Results of a phase II randomized controlled trial.

OBJECTIVE: Fibromyalgia syndrome (FMs) is a chronic, musculoskeletal pain disorder characterized by sleep disturbances, fatigue, and cognitive dysfunction. Heart rate variability biofeedback (HRV-BF) aiming to improve self-regulation and strengthen the parasympathetic nervous system has been shown to be effective in several pain syndromes, but its efficacy in FMs has not been adequately investigated. This Phase II trial aimed to assess the feasibility and preliminary measurement of the improvement induced by HRV-BF in FMs. METHODS: Sixty-four patients with FMs were recruited. Patients were randomly assigned to either the experimental group (EG) or the control group (CG). The EG received 10 HRV-BF training sessions in addition to pharmacological standard therapy. The CG received standard therapies for 10 weeks. The FMs impact on daily life, sleep regularity, sense of coherence, depression symptoms and pain has been assessed as primary outcomes, quality of life as secondary. RESULT: 23 (71.9%) of EG patients completed the intervention and 20 (62.5%) of the CG were re-evaluated at time T1. No side effects were reported. It was not found any statistical differences between groups over time in primary and secondary outcomes. CONCLUSIONS: The HRV-BF intervention did not demonstrate efficacy in both primary and secondary outcomes. However, it is quite feasible in terms of drop-out rate and side effects. Further studies with larger sample sizes are needed to determine its actual efficacy. CLINICALTRIALS: gov with code: NCT04121832.