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

Discussion in 'Long Covid research' started by Andy, Jul 21, 2023.

  1. Andy

    Andy Committee Member

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    "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
     
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  2. Andy

    Andy Committee Member

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    "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."
     
  3. Andy

    Andy Committee Member

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  4. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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    "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)
     
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  5. Sean

    Sean Moderator Staff Member

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    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.
     
  6. Hutan

    Hutan Moderator Staff Member

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    It's a bit surprising to have Gilead fund this study, but there's no obvious problem with the funding.
     
    Last edited: Jul 22, 2023
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  7. Hutan

    Hutan Moderator Staff Member

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    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.

    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: Jul 22, 2023
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  8. Hutan

    Hutan Moderator Staff Member

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    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.

    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?
     
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  9. Hutan

    Hutan Moderator Staff Member

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    I thought this was interesting.
     
  10. Joan Crawford

    Joan Crawford Senior Member (Voting Rights)

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    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.
     
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  11. Hutan

    Hutan Moderator Staff Member

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    Yes. I should have said, it's great that the researchers are aware of PEM, and are investigating it with CPETs. And it sounds as though they may not even ask participants to go to VO2 max. It is indeed just the concern that findings might be weaponised - I can't think how, but I'm sure there is a way.
     
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  12. Trish

    Trish Moderator Staff Member

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  13. Grigor

    Grigor Senior Member (Voting Rights)

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    He's been working with long-COVID physio so I'm sure they're well aware of PEM etc.
     
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