Protocol (United Kingdom) Profiling the response to exercise in Long COVID patients to inform novel rehabilitation guidelines, recruiting, Faghy and Bewick

Andy

Andy

Retired committee member
"The value of clinical cardiopulmonary exercise testing (CPET) within healthcare settings has been established in the last decade. CPET methods remain highly relevant in the COVID-19 endemic phase and should be used to assess those recovering from COVID-19 infection.

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."

https://www.shu.ac.uk/advanced-well...nts-to-inform-novel-rehabilitation-guidelines
 
"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."


"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."


"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."
 
"Advanced Wellbeing Research Centre"
"Sheffield Hallam University’s Advanced Wellbeing Research Centre opened in 2020 and employs a unique model of collaboration, co-production and systems thinking to address the challenge of physical inactivity. We bring communities, businesses, clinical services and the public sector together with academic expertise in health, engineering, robotics, software design, psychology, sport and exercise science and the arts to create meaningful partnerships that co-produce innovations that help people move."

"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."


(Gilead Sciences :nailbiting: see HMT)
 
2) We have developed a study over 18 months with our patients, research, and clinical experts from around the world to develop an individualised 2-day cardiopulmonary exercise test (CPET) that will allow us to investigate exactly what is happening with the body’s physiology.

This is the important bit.
 
Patient Information Sheet said:
The research has been funded by the GILEAD Sciences COVID-19 RFP Program: COMMIT .
Click to expand...

https://research.arizona.edu/covid-19-rfp-program-commit
COVID-19 RFP Program: COMMIT
(COvid-19 unMet MedIcal needs and associated research exTension)

In an effort to further address the unmet medical need in COVID-19, Gilead Medical Affairs is launching the COMMIT program. The COMMIT program will support well defined individual projects of no more than $250,000 USD or equivalent sum; projects that are more than $250,000 will require approval by Gilead prior to submission.

Successful projects should demonstrate clear objectives, defined timelines, a comprehensive operational plan, and propose data that has relevance to the medical community. Note: these projects will not have objectives/endpoints that overlap with studies that are known to be currently underway as of the day of the approval of the proposal, including those studies that are sponsored by either Gilead and/or third parties.
...
Gilead will consider support for research proposals that meet one of the following criteria:

  • Expand data on clinical course and outcome in vulnerable populations:
    • Immune suppressed, specifically- HIV, cancer chronic inflammatory conditions (i.e., RA or IBD), and chronic liver disease, pre-existing pulmonary disease
    • Residents of long-term care facilities/nursing homes, and older adults
    • At risk for healthcare disparities (e.g. Black/African American, socio-economic class)
  • Long-term sequelae (i.e., pulmonary fibrosis, neurologic, cardiac, quality of life)
  • Real world safety and effectiveness of remdesivir used alone or with other agents (JAK inhibitors, IL-6 inhibitors, convalescent plasma and ACE inhibitors and ARBs):
    • Viral kinetics and clinical outcomes
    • Based on duration of treatment (e.g., 5 vs 10 days, shorter courses)
    • Use in early (non-severe) disease
    • Course completion in alternative (non-inpatient setting) or alternative treatment pathways
Click to expand...
It's a bit surprising to have Gilead fund this study, but there's no obvious problem with the funding.
 
Last edited:
Patient Information Sheet said:
The research protocol and all study documentation have been reviewed by an independent group of people called a Research Ethics Committee, to protect your safety, rights, well-being, and dignity. This study has been reviewed and given a favourable opinion by the NHS Research Ethics Committee (IRAS number 313936).

The trial will be monitored by a trial steering group that consists of researchers from the University and its research partners who will regularly review the progress of the study and check study documents for accuracy.
Click to expand...
The Patient Information Sheet doesn't look too bad. There's a lot of talk about recovery, as if it's a foregone conclusion that everyone will recover.

I note that there doesn't seem to be any involvement of people with Long Covid, no Patient Advisory Group, no association with a Long Covid Support Group - so that's a big fail. A Research Ethics Committee is absolutely not the same thing - they can't be expected to know about Long Covid in detail. And the researchers need them, because, although it's not clear, they seem to be planning to use what they learn from this study to evaluate something potentially similar to GET. The article says that they have worked closely with the Long Covid community, but I think they need to provide evidence of that.

This diagnostic tool could play an integral role in disease prognostication and evaluate the integrative response to incremental exercise.
Click to expand...

The Patient Information Sheet also doesn't give any link to a published Protocol. I think Patient Information Sheets should. Does anyone know how to get hold of a protocol using the IRAS number?
 
Last edited:
Patient Information Sheet said:
A visit your local testing site to conduct a baseline assessment. In this visit we will capture the following information:
  • We will take a blood sample from your arm to assess important biomarkers that are associated with COVID-19 severity and recovery.
  • Assess your lung and respiratory muscle function to determine how well your lungs and respiratory muscles are working.
  • Assess your leg muscle size using ultrasound
  • Ask you questions to understand the severity of your symptoms.
  • Gather information about your functional status, quality of life and physical
    capacity. This will include some physical tests.
  • Ask you questions relating to your cognition and your sleep performance.
  • Monitor for a 3-day period how you are feeling and rate your tiredness using
    either a mobile application or paper diary.
Click to expand...
The Patient Information Sheet does not say that any psychological data will be gathered - so hopefully they won't be doing that.
What are people's views on whether people who participate should get copies of their personal data e.g. the results of the CPETS? As well as the data being of interest, it would allow the participants to check that their data is included in analyses in the published paper.

I haven't quite worked out for how long people have an accelerometer and are expected to monitor how they are feeling, but it's not long. I would have thought they should be having people use it for weeks before the CPETS to develop a baseline.
We will also provide you with a diary either through mobile application on your smartphone or paper version for the duration of the study where you can record your experiences of your recovery and also an accelerometer to wear on your trousers. This looks at how active you are in terms of how many steps you are walking and how long you spend doing activities such as housework or sitting down watching tv. We want you to spend your time as you normally would.
Click to expand...


Is this good enough - the 'we will publish if deemed appropriate'? I think the researchers should be saying that publication is planned, and surely only the most exceptional circumstances would stop the findings being published?
If deemed appropriate, the findings may also be published in a peer-reviewed academic journal. In this instance, all your data will be completely anonymous and not contain any information that will identify you.
Click to expand...
 
Patient Information Sheet said:
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.
Click to expand...
I thought this was interesting.
 
Sean said:
2) We have developed a study over 18 months with our patients, research, and clinical experts from around the world to develop an individualised 2-day cardiopulmonary exercise test (CPET) that will allow us to investigate exactly what is happening with the body’s physiology.

This is the important bit.
Click to expand...

Good to see.

I have not read protocol etc but surely they involved patients in the design of the study? It needs to objectively identify and quantify PEM and effects. Otherwise it will likely be weaponised against patients with long covid.
 
You must log in or register to reply here.
Back
Top Bottom