ABSTRACT
Introduction Post-covid-19 syndrome, or Long covid (LC) refers to symptoms persisting 12 weeks after Covid-19 infection. LC comprises a wide range of dysautonomia symptoms, including fatigue, breathlessness, palpitations, dizziness, pain and brain fog. This study tested the feasibility and estimated the efficacy, of a Heart Rate Variability Biofeedback (HRV-B) technique via a standardised slow diaphragmatic breathing programme in individuals with LC. Methods and Analysis LC patients underwent a 4-week HRV-B intervention for 10 minutes twice daily for a total of 4 weeks using the Polar H10 ECG (Electrocardiogram) chest strap and Elite HRV phone application. Outcome measures C19-YRSm (Yorkshire Rehabilitation Scale modified), EQ5D- 5L (EuroQol 5 Dimensions), Composite Autonomic Symptom Score (COMPASS-31), WHO Disability Assessment Schedule (WHODAS), and Root Mean Square of Successive Differences between heartbeats (RMSSD) using a Fitbit device were completed before and after the intervention. The study was pre-registered at clinicaltrials.gov NCT05228665. Results 13 participants (54% female, 46% male) completed the study with high levels of data completeness and adherence. There was a statistically significant improvement in C19YRS-m (p=0.001), EQ5D Global Health Score (p=0.009), COMPASS-31 (p=0.007), RMSSD (p=0.047) and EHODAS (p=0.02). Qualitative feedback suggested participants were able to use it independently, were satisfied with the intervention, and reported beneficial effects from the intervention. Conclusion This is the first study in the literature to report that HRV-B is a feasible intervention for LC and seems to be potentially improving symptoms of LC and dysautonomia.
Subject(s)
Pain , Primary Dysautonomias , Dizziness , COVID-19 , FatigueABSTRACT
IntroductionLong covid (LC), also known as Post-COVID-19 syndrome, refers to symptoms persisting 12 weeks after COVID-19 infection. It affects up to 1 in 7 people contracting the illness and causes a wide range of symptoms, including fatigue, breathlessness, palpitations, dizziness, pain and brain fog. Many of these symptoms can be linked to dysautonomia or dysregulation of the autonomic nervous system after SARS-CoV2 infection. This study aims to test the feasibility and estimate the efficacy, of the Heart Rate Variability Biofeedback (HRV-B) technique via a standardised slow diaphragmatic breathing programme in individuals with LC. Methods and Analysis30 adult LC patients with symptoms of palpitations or dizziness and an abnormal NASA Lean Test (NLT) will be selected from a specialist Long COVID rehabilitation service. They will undergo a 4-week HRV-B intervention using a Polar chest strap device linked to the Elite HRV phone application while undertaking the breathing exercise technique for two 10-min periods every day for at least 5 days a week. Quantitative data will be gathered during the study period using: HRV data from the chest strap and wrist-worn Fitbit, the modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm), composite autonomic symptom score (COMPASS 31), World Health Organisation Disability Assessment Schedule (WHODAS 2.0) and EQ-5D-5L health related quality of life measures. Qualitative feedback on user experience and feasibility of using the technology in a home setting will also be gathered. Standard statistical tests for correlation and significant difference will be used to analyse the quantitate data. Ethics and DisseminationThe study has received ethical approval from Health Research Authority (HRA) Leicester South Research Ethics Committee (21/EM/0271). Dissemination plans include academic and lay publications. Study RegistrationClinicaltrials.gov No: NCT05228665 Strengths and limitations of the studyO_LITo our knowledge, this is the first study of HRVB in long covid and will provide new information regarding the feasibility of the technology-based intervention in this condition. C_LIO_LIThe estimation of efficacy will determine the scope and sample size for a larger controlled trial in the condition that currently has no definitive treatments C_LIO_LIThe study will provide preliminary evidence on the correlation between long covid symptoms and dysautonomia. C_LIO_LIThe limitation of this study is the small sample size of 30 participants which might not give an accurate estimate of efficacy. C_LIO_LIHRV-B is a technology-based intervention, therefore its take-up could be limited in those with a lack of experience in using digital technology in daily life, particularly those from less privileged backgrounds. C_LI
Subject(s)
Pain , Primary Dysautonomias , Severe Acute Respiratory Syndrome , Dizziness , COVID-19 , FatigueABSTRACT
ABSTRACT Background The C19-YRS was the first validated scale reported in the literature for patient assessment and monitoring in Long Covid or Post-COVID syndrome. The 22-item scale contains four subscales measuring symptom severity, functional disability, overall health and additional symptoms. Objectives This study aimed to modify and refine the scale based on psychometric properties, emerging evidence on additional Long Covid symptoms, and feedback from a working group of patients and healthcare professionals. Methods Data were collected from 370 patients who completed the C19-YRS scale in a community Long COVID service. The psychometric properties of the Symptom Severity and Functional Disability subscales were assessed using a Rasch Measurement Theory framework, where all individual scale items were assessed for model fit, local dependency, response category functioning and differential item functioning (DIF) by age group and sex. Additionally, the subscales were assessed for targeting, reliability and unidimensionality. The overall health subscale is a single item, and the additional symptoms subscale is not intended to be summed, therefore neither is appropriate for Rasch analyses. Psychometric results and implications were relayed back to the working group for discussion, alongside clinical evidence of emerging and relevant symptoms not covered by the original C19-YRS. Results Rasch analysis revealed promising psychometric properties of the symptom severity and functional disability subscales, with both displaying good targeting and reliability, although some individual measurement anomalies were noted. The original 0-10 item response category structure did not operate as intended for both the subscales. Post-hoc rescoring suggested that a 4-point response category structure would be more appropriate for both the subscales, and this aligned with patient feedback. This scoring change was implemented, alongside changes in the item composition of the symptom severity and additional symptoms subscales. The functional disability item set, and the overall health single-item subscale remained unchanged. Conclusion A modified version of the C19-YRS was developed based on a combination of psychometric evidence, clinical relevance of the content and feedback from the working group (comprising patients and healthcare professionals). Future studies including NIHR funded LOCOMOTION study will undertake large-scale, multi-centre validation of the modified C19-YRS.