HEART Rate Variability Biofeedback in LOng COVID-19 (HEARTLOC)

NCT05228665 | Unknown

• 1 other identifier: 304567
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Long COVID is a common but highly debilitating illness which develops after infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 or COVID-19). It is thought to affect as many as 1 in 7 people following COVID-19 infection. It can produce a vast array of symptoms including fatigue, breathlessness, fast heart rate, blood pressure disturbance, temperature disturbance, and dry mouth. Many of these symptoms could be explained by the nervous system being predominantly in a stress or 'fight or flight' response, also known as dysautonomia. One way of assessing whether this is the case is by measuring heart rate variability (HRV). This is the time variation between heart beats and is a marker of how stressed the nervous system is or how strong is the 'fight or flight' response. Heart rate variability can be measured using devices which are worn round the wrist or attach to the chest. An increased variability in heart rate corresponds with a more relaxed nervous system and decreased variability with a more stressed nervous system. Monitoring HRV in real-time and implementing interventions such as a breathing regime to maximise HRV is known as HRV biofeedback. The body can be trained out of the fight or flight response and into the 'rest and digest' mode response of the nervous system in this way and potentially significantly improve symptoms. We propose that for people with Long COVID, a programme of structured breathing exercises over 4 weeks whilst tracking HRV can demonstrate an improvement in HRV and consequently improve Long COVID symptoms.

Conditions

COVID-19

Keywords

Long Covid; Post-Covid Syndrome; Post-Covid Condition; Post-Acute Covid Syndrome; Autonomic Nervous System

Outcome Measures

Primary Outcomes (1)

• Modified C19-YRS (COVID-19 Yorkshire Rehabilitation Scale)

  The C19-YRSm will be completed by the patient every week for a total of 6 weeks. There will be a total of 7 C19-YRSm documents completed. The C19-YRSm consists of 17 items with each item rated on a 4-point numerical rating scale from 0 (no symptom) to 3 (life disturbing or affecting all aspects of daily life). The C19-YRSm is divided into four subscales (range of total score for each subscale): symptom severity score (0-30), functional disability score (0-15), other symptoms (0-25), and overall health (0-10). A higher score for the first 3 subscores represents higher severity. Conversely, a lower overall health score represents greater severity.

  Up to 6 weeks

Secondary Outcomes (1)

• HRV (Heart Rate Variability) score

  Up to 6 weeks

Other Outcomes (4)

• COMPASS 31(Composite Autonomic Symptom Score)

  Up to 6 weeks

• EQ5D-5L(EuroQol Five Dimension Quality of Life)

  Up to 6 weeks

• aAP(Adapted Autonomic Profile)

  Up to 6 weeks

Study Arms (1)

Prospective cohort

EXPERIMENTAL

Participants will be shown a paced breathing programme and instructed to implement this for 10 minutes twice daily for 4 weeks. During the 10-minute breathing exercises, the participant will need to wear the Polar H10 chest strap and can remove this when finished. The breathing will ideally be a breathing pattern of a 4-second nasal inhale, and 6-second nasal exhale using the 'resonance' programme in the 'biofeedback' section of EliteHRV app. They will be advised to monitor the graph of HRV on EliteHRV which allows real-time assessment of HRV and to aim to breathe in and out deeply to raise the HRV graph reading as much as possible each time. They will be advised to perform the breathing programme lying down with minimal distractions on waking in the morning and just before bed in the evening, preferably in the same location each time.

Behavioral: Heart Rate Variability Biofeedback (HRV-B)

Interventions

Heart Rate Variability Biofeedback (HRV-B) BEHAVIORAL

Breathing technique twice every day (10 min each) to increase HRV

Prospective cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Confirmed Long COVID based on a positive PCR or antibody test and Long COVID symptoms as per the NICE criteria for post-COVID syndrome
• Current Leeds COVID Rehabilitation service user
• Self-rating of 'moderate/severe' on the Leeds COVID Rehabilitation Service Long COVID participant reported outcome measure (known as C19-YRS)
• Abnormal NASA Lean Test (NLT)

You may not qualify if:

• Age \< 18 years
• Unable to use the wearable or smartphone app technology
• Cognitive problems or mental health disorders causing inability to consent
• Cardiac arrhythmia (current or prior tachyarrhythmia or bradyarrhythmia)
• Existing significant cardiorespiratory disease which might be expected to affect studied symptoms of palpitations, presyncope, breathlessness and fatigue (asthma not included in this definition)

Sponsors & Collaborators

• University of Leeds: lead
• University of Manchester: collaborator
• Leeds Comunity Healthcare NHS Trust: collaborator

Study Sites (1)

Leeds Community Healthcare NHS Trust

Leeds, Yorkshire, LS12 5SG, United Kingdom

RECRUITING

Related Publications (2)

• Corrado J, Iftekhar N, Halpin S, Li M, Tarrant R, Grimaldi J, Simms A, O'Connor RJ, Casson A, Sivan M. HEART Rate Variability Biofeedback for LOng COVID Dysautonomia (HEARTLOC): Results of a Feasibility Study. Adv Rehabil Sci Pract. 2024 Jan 28;13:27536351241227261. doi: 10.1177/27536351241227261. eCollection 2024 Jan-Dec.

  PMID: 38298551 DERIVED

• Corrado J, Halpin S, Preston N, Whiteside D, Tarrant R, Davison J, Simms AD, O'Connor RJ, Casson A, Sivan M. HEART rate variability biofeedback for long COVID symptoms (HEARTLOC): protocol for a feasibility study. BMJ Open. 2022 Nov 21;12(11):e066044. doi: 10.1136/bmjopen-2022-066044.

  PMID: 36410797 DERIVED

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manoj Sivan, MD

  University of Leeds

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manoj Sivan, MD

CONTACT

01133922564; m.sivan@leeds.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Consultant in Rehabilitation Medicine

Model Details: Prospective cohort

Study Record Dates

• First Submitted: January 30, 2022
• First Posted: February 8, 2022
• Study Start: January 24, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After completion of data collection from 30 participants
• Access Criteria: Open Science Framework registration

Locations

GB (1)