COMLOC

The aim of the study is to test a treatment known as “Cognitive Muscular Therapy^TM (CMT)” for long-COVID. This technique has been used previously to treat longstanding knee pain and persistent back pain and we are trying to find out if it works to treat other conditions like long-COVID. The aim of the treatment is to teach patients how to stand, move and breathe with less muscle tension and to reduce the body’s stress response (sometimes called the fight or flight response).

People with long-COVID experience symptoms such as dizziness and fatigue, which have been linked to a condition called dysautonomia (which causes problems with blood pressure and heart rate control). We think that dysautonomia might be linked to a change in the way people breathe. Specifically, we think that breathing rapidly, high in the chest, might trigger the body’s stress response. Therefore, by using CMT to reduce muscle tension and restore a normal breathing pattern, it is possible that patients could experience less breathlessness and improvements in other symptoms associated with long-COVID.

You have been invited because you have either self-identified as experiencing long-COVID symptoms on social media or a research database, or your GP has identified you as having these symptoms. As an individual affected by long-COVID, you are invited as you may benefit from this new treatment.

No, taking part is completely voluntary. If you are interested, contact the researcher (details at the end of this information sheet). If you are not interested, then just disregard this letter.

If you are considering participation in this study, a member of the research team will contact you to assess your eligibility. This process will include questions about your height, weight and long-COVID symptoms related to breathlessness. Should you meet the study’s criteria, the study team will ask you to read this participant information sheet carefully and, if you want to take part, to sign a consent form. If you do not meet the eligibility criteria, any information you have provided will be permanently deleted.

If you agree to take part in the study, you will first be asked to complete a set of questionnaires which allow us to understand your symptoms and how long-COVID interferes with your daily life. You will be asked to complete these same questionnaires after you have finished the treatment and again 3 months after you have finished the treatment. You will also be sent (via post) a chest strap and a wrist-worn activity monitor. You will be asked to wear the chest strap for 24 hours and to wear the wrist-worn device for 7 consecutive days. These devices will collect data on heart rate, heart rate variability, breathing rate and sleep quality which might change because of the treatment. You will be sent a video and instruction on how to wear these devices. Once you return the two devices, you will be formally enrolled onto the study and will receive the CMT treatment.

For the CMT treatment, you will be required to visit the University of Salford on 7 separate occasions, each lasting approximately one hour. These visits will typically be 1 week apart. However, we have built in flexibility so that you can defer your treatment to the following week if you are not feeling capable of attending your session.  When you attend for treatment, we will ask you if you would like the physiotherapist to wear an FP3 face mask. You will also be offered one of these masks. At the start of the first visit, we will measure your weight and height. We will also ask you to breathe into a tube that measures air flow. We will repeat these airflow measures at the end of the last treatment.

At the start of each session, the physiotherapist will place a set of 30-40 small stickers over your chest, stomach and back. To place these stickers, you will need to remove the clothing from your upper body. If you are female, you will wear a sports bra which we can provide if you don’t have one. After the stickers have been placed, you will stand and breathe normally in between two movement sensors which will measure your breathing pattern. This should take about 1 minute, after which you will put a loose-fitting top back on. The physiotherapist who will provide the treatment is female, but you can also request an additional chaperone if it would make you feel more comfortable.

The physiotherapist will begin by explaining the mechanics of breathing, the link between breathing pattern and the body’s stress response and how this may play a role in your long-COVID symptoms. You will then be taught how to consciously relax your stomach muscles using belly breathing. The next stage of the intervention is focused on teaching you to stand with less muscle tension. This is achieved using simple exercises which enable you to build awareness of patterns of muscle tension, particularly around your stomach, back, shoulders and neck. To help you become aware of muscle tension, the physiotherapist may use small muscle sensors which are placed over the neck/shoulder muscles, and which will allow you to see on a screen when your muscles are tense and/or relaxed.

Once you can stand in a relaxed posture, the physiotherapists will work with you to ensure that your ribs and diaphragm move together as you breathe in normal standing. The focus then shifts to everyday tasks which might cause you to feel breathless or stressed. To help you breathe more normally and relax, the physiotherapist will encourage you to imagine these situations and work with you, providing hands on guidance, to help you retain a normal breathing pattern. Once you can do this, you should be able to maintain a normal breathing pattern and stay relaxed in situations which previously caused you to become breathless and/or stressed.

To help you visualise the way in which you breathe, the physiotherapists will ask you to remove your loose-fitting top at specific points during the treatment. You will then stand between the two movement sensors. Data from these sensors will then be processed by the computer to produce a visualization of your breathing pattern on a computer screen. Note that, while the movement sensors do capture a video, this data will not be stored and there will be no recording of you during this breathing visualization.  

As you progress through the treatment, you will gain a new experience of breathing which may feel strange at first but which you will get used to. You may also feel slight dizziness as your breathing improves but this will only last for a short amount of time. The physiotherapist may ask you to wear an oxygen saturation monitor on one of your fingers to monitor changes to your blood oxygen levels during the treatment. To help you understand many of the ideas which underlie the new treatment, animated instructional videos are used. These videos are watched through a special website which we will give you access to at the start of the treatment.

Once you have finished the final treatment session, you will be asked to wear the chest strap and the wrist-worn health tracker for 24 hours and 7 days respectively. Once you have completed this, you will post these devices back to the research team. As soon as we receive these devices, we will send you a short report detailing any improvements in your health metrics which have been picked up by the health tracker.

At the end of the study, we will offer you the opportunity to be interviewed by another researcher (not the physiotherapist) about your experiences of receiving the new treatment. Note that you will only be invited for this interview if you have received four or more treatment sessions. This will be a single interview taken place over a video call. Note that if you are unfamiliar with video calls, we can help you to set this up. After it has finished, the researcher will listen to the recording and summarize your answers. Note that your answers will be completely anonymized, and nobody will be able to link any answers back to you. You can withdraw your consent to be contacted about the interview or reject participation in the interview at a later date.

Once all you have completed the study, we will write a letter to you GP confirming details of the treatment that you have received. In this letter, we will include clinical notes that have been made throughout the course of the treatment.

Unfortunately, we are not able to pay you to receive the new treatment. However, we can cover reasonable travel expenses from within the Greater Manchester area.

This is a very simple, straight forward study. The physiotherapist will be using techniques which are used in routine clinical practice, and these will be complemented with our breathing visualization system which does not carry any risk. However, some people occasionally feel dizzy when receiving breathing retraining because of changes in their blood oxygen saturation level. We will monitor blood oxygenation and ensure that you sit or lie down if you feel dizzy.

You will receive 7 sessions of the new treatment which may reduce your symptoms of long-COVID. However, we can’t promise that everyone will experience clear benefits. The results of the study will help us to understand how to design a future larger study to test this new treatment for long-COVID.

This study is being led (and sponsored) by the University of Salford. The study has been funded by the Dowager Countess Eleanor Peel Trust.

We will need to use information from you for this research project. This information will include your name and contact details. Researchers will use this information to contact you. People 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 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.

We are happy to send each participant in the study a summary of the results. Please indicate on the consent form if you would like to receive this summary and confirm that you are happy for us to retain your contact information for 3 years to allow us to send this information to you. Your anonymized research data will be kept for further 2 years (5 years in total) to allow us to publish the results. If you take part in an interview, then we may use anonymized quotes when writing up our results.  No identifiable data will be kept after the end of the study (apart from contact details if you would like a summary of the results).

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 unless you specifically request that it is destroyed. 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. Note that, if you do decide to withdraw, you would no longer receive the CMT treatment. If you want to withdraw, please notify the study representative listed in the “Further information and contact details” section below.

You can find out more about how we use your information at by visiting our Privacy page or by asking one of the research team.

The university has insurance to cover against any harm to you which may occur whilst you are taking part in these tests. However, if you decide to take legal action, you may have to pay for this. If you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, you can contact the project supervisor Prof Stephen Preece (email: s.preece@salford.ac.uk) and if you are not happy you may then contact Dr Katy Szczepura, Ethics Chair, Allerton Building, University of Salford, M5 4WT via email: K.Szczepura@salford.ac.uk.

If you require more information about the study, want to participate, or if you are already participating and want to withdraw, please contact:

• Email: a.m.handley@salford.ac.uk
• Tel: +44 (0) 161 295 6758