Adapted Autonomic Profile Normative Values

If you have not yet contacted aapstudy@leeds.ac.uk to receive a participant ID please do so now before continuing.

Study Title: Performing aAP (adapted Autonomic Profile) test by healthy volunteers to derive normative values of autonomic function

We'd like to invite you to take part in our research study. Before you decide, it is important that you understand why the research is being done and what it would involve for you. Please take time to read this information and discuss it with others if you wish. If there is anything that is not clear, or if you would like more information, please ask us.

Why is this study being carried out?
The LOCOMOTION project aims to standardise and improve care for Long Covid across three nations in the UK. It comprises of different tasks (studies) within the full project that look at different aspects of care provided within the clinical services of the participating sites. This specific task/study aims at capturing aAP test values from healthy volunteers (those who DO NOT have long Covid or a diagnosis of autonomic dysfunction) to provide normative values for this test and enable comparison with findings from the same test in Long Covid patients from LOCOMOTION. This will help in the management of Long Covid patients and inform other studies within LOCOMOTION.

What is the purpose of the study?
The purpose of this study is to collect data from healthy volunteers on a special test called adapted Autonomic Profile (aAP) to understand what constitutes normal values for this test which will help define abnormal value cut-offs for patients with Long Covid. This will improve the standard of care for people with Long Covid because we can identify those with autonomic dysfunction and help manage their condition better. This will help to inform health professionals decide what constitutes normal range of values so that they can set the cut-off values for abnormal results. Autonomic dysfunction is common in Long Covid patients, it is a condition in which the nerves of the autonomic nervous system are damaged, which affects the heart function, blood pressure, bladder function, digestion, and sexual function.

What do I need to do if I want to participate?
If you want to participate in the study, please complete, sign, and return the consent form to the research team at the University of Leeds. You will then be sent the aAP diary sheet by email or link to an online platform (whichever is preferred) to complete and return to the research team at the University of Leeds by email or submission on the online platform (SmartSurvey). Please see this information below about what will be required to complete the aAP diary sheet.

How long will completing the aAP diary sheet take?
The aAP test could take up to 60 min of your time over the course of one day. The aAP test is best done on a free day when heart rate and blood pressure recordings can be taken at specific times as described in the diary sheet. This is a one-off task, and your participation only entails one day of recordings. However, if you cannot complete all recordings on a particular day, that day can abandoned, and the recordings can be completed on another full day. Once we have recordings from one full day, participation ends at that point.

What equipment do I need to complete the aAP diary sheet?
You will need a standard British Hypertension Society approved Blood Pressure machine for this test, for example Omron machine. We do not provide the machine and you will have to source this for the test. We are able to recommend on the manufacturer based on BHS recommendations. The aAP diary sheet is self-reported which you are able to complete on your own. You are allowed to seek help from family or clinicians if you need any help in completing the diary sheet or recording the findings of the test.

What does the study entail?
Measuring blood pressure (BP) and heart rate (HR) at key times provide information on how your autonomic nervous system responds to key activities in daily life such as with postural change, and also before/after food and exertion. Experience over the decades indicates that it provides adequate data for initial diagnosis and for guidance on treatment.

You will be asked to record time, position (sitting, standing, lying), BP, HR, and key symptoms (such as dizziness or headache) in brief on the aAP diary sheet. This is of particular importance in autonomic conditions and differs substantially from BP/HR recordings commonly used for high BP. You will also be asked to record your age, sex, weight, height, medical conditions, and current medications, with a view to monitor generalisability of findings.

Recordings should be completed:

• Upon waking, after meals, and before sleep: In the day while lying and after standing for 3mins, measured soon after waking, and repeated after breakfast, lunch, dinner and before going to sleep. Also, while sitting on waking, as BP may fall further in some at this time. If it is difficult to stand at other times substitute sitting for standing, especially if after exertion or food. You will also be asked to include a note of what food/drink you consumed.

 

• Before and after activity/exertion: Before and after 3 mins of exertion (physical or cognitive or emotional) morning and afternoon, separate from lunch and dinner. You will also be asked to include details of the activity or exertion. NB exercise exertion levels will be different for everyone, an example of physical is 3 minutes of gentle walking if possible and example of cognitive exertion is doing crossword puzzles for 3 min if possible.

 

• If you wish to add additional readings, for instance when you have symptoms (such as dizziness or headache), record them with the time, event/activity and position (lying, sitting, standing).

Does it involve preparation?
Ensure that you choose a day when you can complete all of the measurements on the aAP diary sheet. It is intended to provide relevant autonomic information during a standard day with usual activities, and thus no change in schedule is needed. The aAP can be repeated on another day in full if you are unable to complete the test on a particular day. We will collect only the data from a full day of recording

Are there any risks of doing the test?
If you have undiagnosed autonomic dysfunction, there is a chance that standing can induce dizziness or fainting, therefore please ensure you are leaning against a wall when checking BP on standing. Abandon the test and lie down if symptoms are worse.

Do I have to take part?
No, taking part in this study is entirely voluntary. You can withdraw at any time, without giving a reason.

What happens to all the information that I give?
All the information we gather will be stored on secure password protected hard drives at the University of Leeds. The three lead researchers Alex Tolson, Sarah Glover and Dr Manoj Sivan will have access to identifiable information (name and email address), but any data shared with other researchers will be only as part of the research study and will be pseudonymised. This means that your name or any other identifiable data will be removed and replaced it with a code number, these other researchers won’t have access to your identifiable information. In this way, researchers can use your data for research purposes relating to this study without identifying you personally.

We will keep all information about you safe and secure. Once we have finished the study, we will keep the research data for up to ten years on secure password protected hard drives at the University of Leeds, to allow us to analyse it all and write papers and reports.

How will we use information about you?
We will need to use information from you that includes your name, age, sex and details of any medical conditions you have and regular medications you take. Researchers who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

We will keep all information about you safe and secure. Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.

What are your choices about how your information is used?

• You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
• We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.
• If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.

Where can you find out more about how your information is used?
This is where you can find out more about how we use your information:
University of Leeds research participant privacy notice

• A leaflet available from www.hra.nhs.uk/patientdataandresearch
• By sending an email to our Data Protection Officer or Chief Investigator of Locomotion (see
• below).
• If you are not happy with our response or believe we are processing your data in a way that is not right or lawful, you can complain to the Information Commissioner’s Office (ICO) (www.ico.org.uk or 0303 123 1113). Our data controller registration number provided by the Information Commissioner's Office is Z553814X.

Who can I contact if I have a complaint?
If you want to complain about how researchers have handled your information, you should contact the research team. If you are not happy after that, you can contact the University of Leeds Data Protection Officer (Email: dpo@leeds.ac.uk). Our postal address for data protection issues is University of Leeds Secretariat, Room 11.72 EC Stoner Building, Leeds, LS2 9JT. Our telephone number is +44 (0)113 2431751. Our data controller registration number provided by the Information Commissioner's Office is Z553814X.

If you are not happy with their response or believe they are processing your data in a way that is not right or lawful, you can complain to the Information Commissioner’s Office (ICO) (www.ico.org.uk or 0303 123 1113).

What will happen to me if I take part?
Nothing will happen to you personally. The data we gather will help inform management of patients with Long Covid and potentially other conditions with autonomic dysfunction.

Are there any possible disadvantages or risks from taking part?
The main disadvantage of the study is that you are sharing information. We have taken every precaution to protect this information in line with legal protections and obligations, and it will be made anonymous when sharing with the wider research team. There is also a time burden of completing the test, but as you are able to understand your autonomic function and are able to discuss your results with the research team. If any of your results are grossly abnormal (based on available literature of similar tests for autonomic dysfunction, for example, rise in heart rate >30 beats per second on standing or drop of blood pressure > 20 mm Hg on standing), the research team will flag this to you and the clinician researcher Dr Manoj Sivan can discuss the findings with your General Practitioner and recommend suitable referrals to relevant specialists for further management.

What are the possible benefits of taking part?
Taking part is your opportunity to participate in improving our understanding of autonomic function in the human body. The data collected will inform us about the normal range of blood pressure and heart rate of the aAP test which in turn will help us understand the extent of autonomic dysfunction in Long Covid. Our aim is to use the research results to help improve NHS care services in the NHS in the near future as it responds to the unfolding effects of the Covid-19 pandemic.

Will I be reimbursed for taking part?
No, you will not be reimbursed for taking part in this study.

What will happen if I decide not to carry on with the study?
You can stop at any time, without giving a reason and without penalty, by advising the researchers of this decision. Participation is voluntary and even if you originally said yes, this decision can be reversed at any stage. If you do withdraw from the study, data collected whilst you have been in the study will be used for research as detailed in this information sheet. Any data you provide after you have withdrawn from the study will not be provided to the research team.

What will happen at the end of the study?
The research team will analyse the data and would recommend normative values for heart rate and blood pressure fluctuations with daily life stimuli in normal healthy volunteers. The data will help define the normal and abnormal thresholds for the aAP test. The research team will write some papers and reports, including a ‘lay summary’. You will not be identified from any report or publication placed in the public domain. We might include quotes or comments if you have given any, but nothing will be used that identifies you.

What if there is a problem?
If a participant in University sponsored research is ever considered to have suffered harm through their participation, the University has arrangements in place to provide for compensation. If you have a concern about any aspect of this study, please speak to the Chief Investigator [Dr Manoj Sivan, Tel: 0113 39 22647, Email: m.sivan@leeds.ac.uk], who will do their best to answer your query. The researcher should acknowledge your concern within 10 working days and give you an indication of how they intend to deal with it. If you remain unhappy or wish to make a formal complaint, please contact the University of Leeds Research Governance office email governance- ethics@leeds.ac.uk or call 0113 343 7587.

How have patients and the public been involved in this study?
People living with Long Covid helped to develop this research proposal and are still involved in overseeing how it is managed.

Who is sponsoring LOCOMOTION?
LOCOMOTION is sponsored by the University of Leeds.

How is LOCOMOTION funded?
LOCOMOTION is funded by the National Institute for Health Research. No additional funding is being requested for this particular study as this study is being undertaken as part of ESREP project in the University of Leeds.

Who has reviewed the study?
All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect participants’ interests. This study has been reviewed and given favourable opinion by the Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (REC reference 21/YH/0276).

Further information and contact details:
If you would like to discuss the research with someone beforehand (or if you have questions afterwards), please contact the Investigators in the first instance and someone will get back to you promptly:

Chief Investigator:
Alex Tolson:
Sarah Glover:
Thank you for considering taking part in LOCOMOTION
Please click here to download a copy of the information sheet