Official Title
HEART Rate Variability Biofeedback in LOng COVID-19 (HEARTLOC)
Brief Summary

Long COVID is a common but highly debilitating illness which develops after infectionwith severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 or COVID-19). It isthought to affect as many as 1 in 7 people following COVID-19 infection. It can produce avast array of symptoms including fatigue, breathlessness, fast heart rate, blood pressuredisturbance, temperature disturbance, and dry mouth. Many of these symptoms could beexplained 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 bymeasuring heart rate variability (HRV). This is the time variation between heart beatsand is a marker of how stressed the nervous system is or how strong is the 'fight orflight' response. Heart rate variability can be measured using devices which are wornround the wrist or attach to the chest. An increased variability in heart ratecorresponds with a more relaxed nervous system and decreased variability with a morestressed nervous system. Monitoring HRV in real-time and implementing interventions suchas a breathing regime to maximise HRV is known as HRV biofeedback. The body can betrained out of the fight or flight response and into the 'rest and digest' mode responseof the nervous system in this way and potentially significantly improve symptoms. Wepropose that for people with Long COVID, a programme of structured breathing exercisesover 4 weeks whilst tracking HRV can demonstrate an improvement in HRV and consequentlyimprove Long COVID symptoms.

Detailed Description

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. Researchers will monitor the participant's comfort and ease during this
breathing demonstration, if participants find this breathing rate too slow then it can be
tailored to ensure a tolerable slow breathing rate with minimal impact on symptoms - most
likely by reducing both inhale and exhale in 1 second increments until a more tolerable
breathing rate and pattern is found. 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. Participant Information
Sheet provides more clarification and instruction on this. 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.
During this 4 week period researchers will make weekly contact by phone to check progress
and help resolve any queries. The participant will also have contact details of the
researchers in case of any technical issues with Polar H10 chest strap or app during the
4 week study period.

Unknown status
COVID-19

Behavioral: Heart Rate Variability Biofeedback (HRV-B)

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

Eligibility Criteria

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United Kingdom
Locations

Leeds Community Healthcare NHS Trust
Leeds, Yorkshire, United Kingdom

Investigator: Manoj Sivan, MD
Contact: 01133922564
manoj.sivan@nhs.net

Contacts

Manoj Sivan, MD
01133922564
m.sivan@leeds.ac.uk

Manoj Sivan, MD, Principal Investigator
University of Leeds

University of Leeds
NCT Number
Keywords
long COVID
post-COVID syndrome
Post-COVID condition
post-acute COVID syndrome
Autonomic Nervous System
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome