PORIAS-HF

The difficulty of the heart to properly pump out blood to the rest of the body is called heart failure (HF). It can be caused by muscle weakness or increased pressure inside the pump (stiffness of the muscle).

Physical exercise programmes (e.g. walking, running, cycling) aim to improve the heart’s ability to pump out blood and thus the individual’s ability to perform general daily activities. However, these physical exercise programmes have been cut short due to the COVID-19 pandemic. With many people with HF being asked to shield or self-isolate, it is important to develop a physical exercise service to support them.

Our team has developed a novel physical exercise programme for people with HF which can be delivered via a website on a personal computer, smartphone or tablet. Therefore, the purpose of the study (which is a collaboration of our group with Sheffield Teaching Hospitals NHS Foundation Trust and King’s College London) is to test whether such a programme could be acceptable by people with HF. The study is funded by a Sheffield Hallam University Creating Knowledge grant.

If you live in South Yorkshire and would like to take part, carry on reading!

How do I know if I am a suitable participant for the study?

We are recruiting people with heart failure (confirmed by their clinicians), aged 18 years and over and able to exercise.

We are particularly interested in people who have a scheduled major heart surgery, pregnant women, people with implanted devices that regulate the heart (ie. inserted to the heart via a surgery/operation), those with increased blood pressure in their lungs.

The study’s clinician (the Consultant Cardiologist at Sheffield Teaching Hospitals NHS Foundation Trust) will confirm whether you can participate or not based on your medical history.

Suitable participants need to have an internet connection and will receive all the necessary technical support and training / computer equipment (e.g. cables, webcam, microphone etc). The research team will assess the prospective participant’s needs and it may be possible to loan tablets to a small number of participants. Although the training equipment will be on loan, any computer equipment provided to the participants (apart from the actual computer or device) will be theirs to keep.

What will happen if I take part?

We will contact you by phone or e-mail to answer any questions you may have about the study. We will then ask you questions about your medical history to check whether you can participate.

What will I be required to do?

The whole study will be done remotely with no personal physical contact, using phone and video calls. So, once you agree to participate in the study and we receive your consent in writing, we will send you an information pack that includes:

  • questionnaires
  • a manual (available only in English language) of detailed procedures including how to set up your connection with us
  • automated blood pressure monitor (if appropriate)
  • webcam and microphone and/or tablet (if appropriate)
  • essential equipment for your initial physical assessments such as a tape and a 4-pound dumbbell (for women) and 8-pound dumbbell (for men)

Once you receive the package, we will contact you to arrange a video appointment to perform the initial assessment (video-appointment 1). At the end of the study or if you wish to withdraw, we will ask you to return the webcam, microphone and/or tablet (delivery expenses will be covered by Sheffield Hallam University). You will be able to keep the remaining equipment.

Video appointment 1

The first video appointment will include us recording your demographic data including stature and weight (you will need to provide us with your latest figures, no assessment will take place), age, sex, and your medical history (which involves us asking questions about your health and checking for allergies and current conditions/medications). Your blood pressure will also be assessed and you will be asked to complete three questionnaires related to your current health status as well as your quality of life (these questions will be related to your physical and mental ability to perform daily activities).

We will then assess your physical ability to perform daily activities with three simple physical exercise tests:

  1. 30-second chair stand test: In this test you will be asked to sit down and stand up from a chair for 30 seconds as many times as you can. Time will be kept by the assessor.
  2. Arm curl (biceps) test: In this test you will be asked to arm curl (i.e. curl/flex your upper arm) as many times as you can for 30 seconds raising 4 or 8 pounds for women and men respectively.
  3. Step in place test: In this test you will be asked to march on spot for 2 minutes by raising your knees above a certain point which you will mark on a wall or chair with the provided tape (as instructed by the assessor). The assessor will count the times which your knees exceeded the marked point. Through this test, we will assess your fitness (ie. your heart’s ability to work for an extended period of time).

After 3 months, you will have a second video appointment with us to perform the same exercises.

Physical exercise programme

Following the initial assessments, you will be allocated at random to one of two groups.

Group A

Group A will perform our exercise programme consisting of 2-3 (3rd time optional) exercise sessions per week, for 8 weeks. The group sessions will be delivered online in real time (a group will consist of roughly 8 participants and the instructor). The exercise programme will mainly consist of body weight (no added external weight) and chair-based exercises which will be based on your own physical ability and at an intensity that will be associated with light to moderate breathlessness. All the exercises will be demonstrated live during the online session and appropriate feedback will be given to participants in real time. The online group sessions will be performed on Monday to Saturday slots (8am to 8pm; at times that would be convenient for the group) to facilitate all participants’ needs. If you feel more comfortable or you want to make things more fun, you may ask someone to be present during your exercise session.

Participants in Group A will also be invited to attend three lifestyle workshops. These workshops (one before the exercise sessions begin and two during the exercise programme) will be performed online and will provide information to the attendees regarding the heart failure (e.g., how to self-manage the disease, and spot signs for early intervention/medical help), and the benefits of physical activity and a healthy lifestyle (e.g., healthy diet, benefits of avoiding tobacco and reducing or avoiding alcohol consumption) on the management of heart failure. These workshops aim to be interactive (with open questions and discussions between the speaker and the attendees) in order to increase the interest and promote participation. The workshops will be performed by a member of our research team and the session will not be recorded.

Group B

Group B will follow a self-care exercise programme consisting of 3 or more exercise sessions per week. Participants in group B will receive two exercise programmes that could alternate as they wish during the week. The first exercise programme will consist of chair-based exercises, and a DVD or USB stick with specific videos will be provided. For the second exercise programme, we will provide Group B participants with a manual (available only in English language) for walking, consisting of instructions of how to structure and progress an 8-week walking programme based on personal physical abilities. Both exercise programmes will be explained in detail by the exercise specialist. Group B will have video- and phone-calls with the exercise specialist (to address questions and track progress), once per week for 8 weeks.

Interviews

Following the completion of the exercise programmes for both groups, a sample (mixture of genders, younger and older participants from both groups) of approximately 8-10 participants will be selected to be interviewed (one-to-one). The interview will last up to 1 hour and will take place either in a real time online videocall or via telephone (as per participants’ preference). The aim of the interview is to explore the acceptability of the exercise programme and the study’s procedures by the participants. The interview will be recorded (recordings will be anonymised and will be kept for 7 years), and a member of our research team will transcribe them as part of the analysis. For the publication of our findings, direct quotes from the interviews might be used but they will remain anonymised.

Resource use diary

A diary will be provided to each participant for both groups where they will be asked to fill in during the exercise programme. The diary concerns information regarding the expenses of individuals for medical care and prescription. It also contains a field where participants are asked to provide information for non-prescribed physical activities that might be performed parallel to our exercise programme.

What are the possible benefits of taking part?

Physical activity/exercise improves your overall health and reduces the risk of worsening your existing condition. This is why physical exercise is suggested as a treatment by the clinicians in people with HF. The multiple benefits of exercise include among others improvement of your cardiorespiratory fitness (the ability of the heart and lungs to function better), cardiovascular health (ability of blood to be transferred in the appropriate amount and time to the body’s blood vessels), musculoskeletal health (ability of your muscles and bones to function better), and mental and cognitive health (an improvement in your psychology and in the ability of the brain to function better). You will also benefit from the behavioural change support (experts will help you to change to a healthier lifestyle and habits) and the educational workshops (these will give you the opportunity to learn more about HF, how to manage your symptoms and how exercise and physical activity could help you).

What are the possible disadvantages and risks of taking part?

During the physical exercise tests, you might feel a burning sensation on your leg or arm muscles which will disappear seconds after the termination of the test.

Are there any expenses or payments involved?

All participants will receive upon request a £15 gift voucher as a token of appreciation for taking part in the study. No other expenses, however, will be paid.

If I decide to participate, will my GP be notified?

We plan to contact your doctor about your participation in the study via a letter.

What if I change my mind during the study?

You are free to withdraw from the study at any time. We will use all of your data up to the point of withdrawal as this will help with our analysis. A decision not to carry on with the study will not affect the quality of medical care you receive in any way.

Will anyone be able to connect me with what is recorded, collected and reported?

Sheffield Hallam University will collect information from you in accordance with the Research Ethics Committee’s instructions. Sheffield Hallam University will use your name, gender, date of birth, contact details confidentially to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from Sheffield Hallam University and regulatory organisations may look at your research records to check the accuracy of the research study. The only people in Sheffield Hallam University who will have access to information that identifies you will be people who need to contact you to audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name or contact details. Sheffield Hallam University will keep identifiable information about you from this study for 7 years after the study has finished and your clinical team who are collaborating with us at SHU will be notified of your progress. They will be contributing to the analysis and the reporting of the results of the research that you are helping us with.

What will happen to the information from the study?

It is anticipated that the results of the study will be presented at scientific meetings and published in a scientific journal. The overall results will be available to you; however, it will not be possible to provide you with an individualised report of your performance.

What if there is a problem?

Any complaint about the way you have been dealt with during the study or any possible harm you might have suffered will be addressed.

When will I have the opportunity to discuss my participation?

If you would like more information about the study at any point, you are invited to contact:

Dr Markos Klonizakis Sheffield Hallam University Tel 0114 225 5697.

You should contact the Data Protection Officer if: i) you have a query about how your data is used by the University, ii) you would like to report a data security breach (e.g. if you think your personal data has been lost or disclosed inappropriately), iii) you would like to complain about how the University has used your personal data [email protected].

You should contact the Head of Research Ethics (Professor Ann Macaskill) if: you have concerns with how the research was undertaken or how you were treated [email protected].

Postal address: Sheffield Hallam University, Howard Street, Sheffield S1 1WBT

Telephone: 0114 225 5555.

What if I am harmed?

In the event that something does go wrong, and you are harmed during the research study, unfortunately, there are no special compensation arrangements. Nevertheless, if you are harmed as a result of someone’s negligence then you may have grounds for legal action for compensation, but you may have to pay your legal costs.

Who is organising and funding the research?

This study is being funded by Sheffield Hallam University which is also responsible for the conduct of the study. The investigators of this study will not receive any payment for conducting this research.

Legal basis for research for studies

Sheffield Hallam University is the sponsor for this study based in the United Kingdom. We will be using information from you and/or your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. Sheffield Hallam University will keep identifiable information about you for 7 years after the study has finished. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally identifiable information possible. You can find out more about how we use your information at https://www.shu.ac.uk/about-this-website/privacy-policy/privacy-notices/privacy-notice-for-research. However, all clinical research is reviewed to ensure that participants are treated appropriately, and their rights respected. This study was approved by NHS ethics committee and specifically the Black country REC/HRA committee with approval reference number being 21/WM/0056. Further information at https://www.shu.ac.uk/research/ethics-integrity-and-practice

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