This diagnostic tool could play an integral role in disease prognostication and evaluate the integrative response to incremental exercise. Date from such assessments can enable practitioners to characterise cardio-respiratory fitness and identify reasons for physical impairment or abnormal cardio-respiratory function.
More than 50% of patients admitted to hospital will experience cardiorespiratory issues and significant morbidity during their recovery and will require significant rehabilitative support. In this context, measurements obtained from an assessment of cardio-respiratory responses to physiological stress could provide insight regarding the integrity of the pulmonary-vascular interface and characterisation of any impairment or abnormal cardio-respiratory function.
Current approaches to rehabilitation are being developed on existing knowledge from Severe Acute Respiratory Syndrome (SARS) and Acute Respiratory Distress Syndrome (ARDS) related illness. These provide important insight but do not provide insight into the novel challenges provided by COVID-19.
This study is currently open for recruitment and we are looking for people with confirmed or suspected Long COVID to come forward to take part in this essential research at our Sheffield, Derby and Newcastle sites.
Following the positive response and demand for this research we are working hard to increase the number of study locations so please keep checking back to the page for updates on locations and progress of the study.
If you would like to participate in this project please contact your local study site directly:
Sheffield: Dr Tom Maden-Wilkinson - t.maden-wilkinson@shu.ac.uk
Derby: Dr Mark Faghy - M.Faghy@derby.ac.uk
Newcastle: Dr Emily Hume - e.c.hume@northumbria.ac.uk
For general enquiries about the study please contact the studies Chief Investigator, Dr Mark Faghy - M.Faghy@derby.ac.uk
FAQ
Why are you doing this study?
Ever since patients started reporting ongoing issues and symptoms following an infection with COVID-19 we have been very interested to learn about the way in which Long COVID affects patients’ lives. To date, we have completed several investigations that have helped shape our understanding and this project is the next part of the process. We are specifically looking to increase the understanding of the mechanisms of why people with Long COVID experience symptom exacerbation following any form of exertion. As a group of researchers and scientists, we have worked closely with the Long COVID community to develop these studies to maximize the benefits to people with Long COVID and make sure that studies are meeting the priorities of people with Long COVID.
One of the key areas that have developed because of this has been the need to further understand why some people with Long COVID suffer from Post Exertional Malaise (PEM) or Post Exertion Symptom Exacerbation (PESE) following Physical, Mental, or Emotion exertion. We know that PEM/PESE happens following mental and emotional exertion and this does require investigation. For this study, we have chosen to use a physical stimulus so that we can accurately measure the level of exertion. Some of the mechanisms that are being suggested as a cause of excessive fatigue and PEM/PESE are directly involved and are easily measurable during exercise.
Why have we chosen to study physical exertion?
We know that PEM and PESE are brought about by mental and emotional exertion as well as physical exertion and this is something that we also need to increase our understanding of. To better understand PEM and PESE we first need to look at the different forms of exertion separately to understand the impact this has on your symptoms. Later in the research, we will be looking at mental and emotional exertion and also how the different forms of exertion interact.
Do I have to take part in this study?
No, your participation is completely voluntary, and it is up to you to decide whether to take part.
I have ME/CFS or fibromyalgia as well as Long Covid, can I take part?
If you had ME/CFS or fibromyalgia before you were infected with COVID-19, and your symptoms have got worse, or you have additional symptoms after your infection then you are eligible to take part in this study. We will screen you to make sure it is safe for you to participate; this includes making sure that your post-exertional symptoms are not classified as severe/very severe during our detailed screening processes.
I’ve heard that exercise is dangerous for people with Long COVID.
Exercise can be dangerous for anyone if it is not prescribed or monitored correctly. We have closely observed that patients with Long COVID experience an exacerbation when they have engaged in physical activity/exercise. We also know that engaging in exercise for some people with Long COVID can be dangerous and therefore before you engage in any exercise as part of this study you will undertake a detailed screening to determine if you are suitable to take part. This involves documenting your COVID-19/Long COVID history and information on any diagnosed clinical pathologies which include pericarditis and myocarditis. All subsequent testing sessions will also be relative to your current functional status, and you will not be asked to do anything that you are not happy or comfortable with.
I have been told I am not suitable/eligible to participate, but I really want to.
We really appreciate that you want to take part, but our screening processes have been specifically developed to keep people safe. It is hoped that the learning that takes place from this study will allow us to develop intervention and support approaches for all patients with Long COVID.
How will you screen for post-exertional malaise/symptom exacerbation?
PEM/PESE will be screened for during an initial telephone consultation. To do this we will complete the DePaul Symptom Questionnaire. If it is determined from this that you have severe/very severe PEM then you will not be able to participate in the study. For those participants that are eligible we will complete a more detailed screening of your COVID-19/Long COVID history which includes a full account of your symptoms. It may be deemed from this session that it is not safe for you to participate in this study, and this is important to ensure the safety and avoidance of severe PEM/PESE.
What if the test highlights something that may be deemed worrying/concerning?
Whilst the research team are working closely with clinical collaborators, this test will be conducted by clinical exercise scientists that are not medically trained. Therefore, we are not able to provide you with any clinical diagnosis.
We have established strict exercise termination criteria that will be adhered to at all times. If your test is stopped for any reason, you will be given an explanation as to why and asked to contact your GP/Long COVID clinic for further assessment and investigation.
If urgent medical attention is required, the research team will contact the emergency services. In any of these instances, the research team will complete an adverse event report which will be submitted to the ethics committee for review which will notify them of the details/actions and steps taken in this case.
I have some doubts about completing the testing. Will I be ok?
The research team involved in delivering this project is experienced in delivering clinical exercise assessments and we have developed detailed operating procedures and risk assessments. We have worked closely with a team of patient and public representatives and clinicians to develop this protocol which has been reviewed and approved by an NHS research ethics committee.
Our protocol has been specifically designed to make sure that you are working within your current physical capacity and this is not a maximal or graded exercise test and has not been designed to push you to your physical limits. We will ask you to exercise but we can learn a lot from working at safe and tolerable levels.
If you want to stop at any point, then you will be able to do so.
What happens if I experience a symptom exacerbation following testing?
You might experience an exacerbation following the testing. Through our adapted protocol though, we aim to prevent this but we cannot promise that this will not happen. We will not test you beyond the information we need to collect and we will be in constant communication with you throughout your participation. All details relating to symptoms will be recorded and inform future learning.
What if I cannot complete all assessments?
Not being able to complete all the assessments is completely ok. We will work with you and within your capability to learn as much as possible, but we will never push you to complete anything that you are not happy or comfortable with or able to do.
Why have you decided to do a two-day CPET?
Two-day CPET tests are the gold standard tests to determine changes in physiological function and capacity. This will help us to better understand what is happening in the body during and after exercise on subsequent days. To date, there is very little detail about how the different systems of how the body work and interact with Long COVID and how this is affected by exercise.
Why do you need to track my symptoms and how do I do this?
Monitoring your symptoms is a key part of learning about how people with Long COVID respond to exercise. The data we collect when you are with us in the laboratory is only one part of the puzzle and we will track your symptoms over several days to help further increase our understanding. To do this, you will need access to a smartphone. If you don’t have access to a smartphone we can provide you with a paper version.
I already track my symptoms using an app/device (Visible/Fitbit/Oura ring etc) - are you interested in my data?
Yes, if you are willing to share your data with us, we would be interested in comparing data collected using different methods to the data we are collecting as part of the study.
If I come into the laboratory, what precautions are you taking to prevent Covid infection?
Members of the research team will always wear N95 masks and take daily lateral flow tests. All testing sessions will take place in a well-ventilated room, with HEPA filters and with the windows open. We also prevent back-to-back testing to allow all rooms/surfaces and equipment to be cleaned and aired thoroughly using a strict standard operating procedure. We will accommodate any requests that you make to ensure that you feel safe when visiting us.
If I come into the laboratory, is there somewhere I can rest and/or lie down?
Yes, we have a comfy recliner chair. You will sit or lie down in this chair for the tests and we can adjust it to suit you, including making it flat. You can also spend time quietly in the chair at any time during your visit if you need to rest. We can also close the blinds and dim the lights so that the room is dark.
Are there changing facilities available?
Yes – all sites have access to private and accessible changing facilities.
Is there somewhere to park nearby? Can I be dropped off at the entrance to your building? Is there a lift?
Parking is available at each study site, and we will cover any travel and parking expenses. Just keep your receipts and share them with the study team. Access and parking have been arranged to reduce the time/distance required for you to walk. All buildings have access to lifts, and we also have access to a wheelchair if this is required; we will need a few days' notice to arrange this for you.
Can I bring someone with me to the visits?
Yes of course. We will provide them with somewhere to wait whilst you are with us. We will also be able to offer light refreshments for them whilst they wait.
Who is funding the study?
Gilead Sciences are the funding body for this trial. They are covering the financial costs associated with the study, but the data remains the intellectual property of the research team and they will not be involved in the analysis or the publication of the results.
