COVID-19HEARTLOCNCT05228665
HEART Rate Variability Biofeedback in LOng COVID-19 (HEARTLOC)
A study testing Heart Rate Variability Biofeedback (HRV-B) in people with COVID-19, run by University of Leeds at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Heart Rate Variability Biofeedback (HRV-B)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jan 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Community Healthcare NHS Trust
Leeds, Yorkshire, LS12 5SG
Manoj Sivan, MD, 01133922564, manoj.sivan@nhs.net
About this study
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Heart Rate Variability Biofeedback (HRV-B)
- Keywords
- Long Covid, Post-Covid Syndrome, Post-Covid Condition, Post-Acute Covid Syndrome, Autonomic Nervous System
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Rate Variability Biofeedback (HRV-B)Behavioural
Breathing technique twice every day (10 min each) to increase HRV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Heart Rate Variability Biofeedback (HRV-B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 weeks
Secondary outcomes (1)
HRV (Heart Rate Variability) score
We will be collecting both medium and short term HRV data. Participants will wear a Fitbit for 6 weeks which will collect HRV data whilst sleeping each night, thus collecting 6 weeks of consecutive nocturnal HRV data. In addition they will wear a Polar H10 chest strap for 10 minutes twice daily whilst performing breathing exercises to collect frequent short-term HRV data. For both data sets an increase in HRV is expected as this denotes an improvement in heart rate variability.
Fitbit measures HRV in milliseconds on a scale from 0 to 100 (or more if HRV exceeds 100ms) A higher score represents more variability and therefore improvement.
The Elite HRV also provides a score of HRV on a scale from 0 to 100 with a higher score representing improvement. The score is derived from the root mean square of successive differences between heartbeats in milliseconds (rMSSD).
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start24 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, Leeds Comunity Healthcare NHS Trust
- Responsible party
- Principal investigator, Dr Manoj Sivan, University of Leeds
- Investigators
- Manoj Sivan, MD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228665
- Sponsor's protocol ID
- 304567
- Acronym
- HEARTLOC
- Status last verified
- Oct 2022
- First submitted
- 30 Jan 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available on requesting the corresponding author
Publications
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.
PubMed 38298551Corrado 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.
PubMed 36410797
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEART Rate Variability Biofeedback in LOng COVID-19 (HEARTLOC)
- ClinicalTrials.gov ID
- NCT05228665
- Acronym / sponsor ID
- HEARTLOC / 304567
- Conditions
- COVID-19
- Keywords
- Long Covid, Post-Covid Syndrome, Post-Covid Condition, Post-Acute Covid Syndrome, Autonomic Nervous System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- University of Manchester, Leeds Comunity Healthcare NHS Trust
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | Experimental | Behavioral: Heart Rate Variability Biofeedback (HRV-B)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Rate Variability Biofeedback (HRV-B)Breathing technique twice every day (10 min each) to increase HRV | Behavioural | Prospective cohort |
Primary outcome
Modified C19-YRS (COVID-19 Yorkshire Rehabilitation Scale)
Time frame: Up to 6 weeks
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.
1 secondary outcome
HRV (Heart Rate Variability) score
Time frame: Up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Derived from this study: PubMed 38298551Corrado 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.
- Derived from this study: PubMed 36410797Corrado 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.
- Individual participant dataSharing planned: Yes. Data will be made available on requesting the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manoj Sivan, MD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Rate Variability Biofeedback (HRV-B) in people with COVID-19, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manoj Sivan, MD (01133922564, m.sivan@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified C19-YRS (COVID-19 Yorkshire Rehabilitation Scale) (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05228665, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.