Lower-leg venous ulcers are a common complication of venous disease. They can be painful and they often take a long time to heal.
Current treatment for venous ulcers involves the application of high-level compression from compression stockings or multi-layer bandaging. Although high-level compression increases the rate at which venous ulcers heal, additional strategies are needed to improve healing rates and patients’ quality of life.
Exercise training is an effective strategy for improving circulation and quality of life. Because of this, it has been suggested that exercise training might be a useful therapy for people with venous ulcers. We recently conducted a small-scale study and found that exercise is a feasible therapy, however, people who receive treatment at home for venous ulcers, have difficulty in attending exercise sessions in community centres.
The purpose of this study is to: a) develop an exercise that is suitable and appropriate for people with venous ulcers, who receive treatment for those at home and b) explore the feasibility and refine the intervention so that its effectiveness is explored at a later stage.
FISCU II is sponsored by Sheffield Health and Social Care NHS Foundation Trust. It is a collaboration of our group with Sheffield Teaching Hospitals NHS Foundation Trust and the University of Nottingham and funded by the National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) Programme (grant number: PB-PG-0418-20021). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
What will happen if I take part?
This study will take us approximately 12 months to complete but if you agree to take part in the study we will only ask for your help for a maximum of 1 visit (if you take part in Phase 1 of the study) or 7 months (if you take part in Phases 2 and 3 of the study).
Phase 1: If you are eligible for the study and are happy to take part we will arrange for a member of our research team to visit you at home for a face-to-face interview or arrange for you to come at the Centre for Sport and Exercise Science of Sheffield Hallam University to take part in a round table discussion alongside other people with venous ulcers. Prior to the interview or the discussion, you will be asked to sign a consent form, which will confirm your willingness to take part. Once this happens, the discussion/interview will commence, with the main aim being to help us develop an exercise intervention, which would be suitable for people like you. We will discuss different exercises, ways of conduct between the research team and yourself, frequency of support visits, the content of the support manual that will be given to the participants etc.
We will then go away and using your ideas and those of other participants, we will develop the exercise intervention and be ready to move to Phase 2.
Taking part in Phase 1, doesn’t necessarily mean that you will take part in Phase 2 as well. This will be something that will be based on your decision and a screening visit.
Phase 2: If you are eligible for the study and are happy to take part we will arrange for a member of our research team to visit you at home or arrange for you to come at the Centre for Sport and Exercise Science of Sheffield Hallam University for a screening visit. You will be asked to sign a consent form agreeing to take part in the study. You will be given a copy of your signed consent form and this information sheet to keep. During the screening visit your eligibility for the study will be assessed in more detail. If you are eligible to take part then you will be asked to complete some tests to assess your ulcer characteristics, exercise capacity, quality of life, and general health. These tests are described in greater detail below. This appointment will take up to 40 minutes.
Following that appointment, you will be randomly assigned to one of two groups. The group in which you are placed depends on chance and is rather like tossing a coin. In the first of the two groups, people enrolled will be invited to undertake 3 sessions of self-managed exercise training each week for 12 consecutive weeks at the comfort of their home – 36 sessions in total. Each session will be designed to last up to 60 minutes and will involve a combination of chair-based aerobics, muscle-strengthening and flexibility exercises. Before starting up the exercise programme you will receive thorough support to be able to do all the exercises correctly, alongside a manual, which will be designed in Phase 1 of the study. Furthermore, an experienced member of our team will visit you frequently and ring you to monitor your progress and support you.
You will continue to receive your normal ulcer treatment. This means that you will keep wearing compression stockings or bandages, until your ulcers heal completely.
In the second of the two groups, people will follow their normal treatment, but they will be not assigned to an exercise programme.
All participants will be asked to conduct another series of tests – same as the ones that were completed at the beginning of Phase 2 – at the end of the 3-month period and then again 6 months after the initial tests.
At the end of Phase 2 and if you are willing, we would like you to take part in Phase 3 of the study. During this you will be asked to have a 1-hour interview to tell us about your study experience so that we can identify what went well and what didn’t.
Visit 1 (week 1): Medical screening, habituation and baseline assessments (up to 40 minutes in total), Sheffield Hallam University (Collegiate Crescent) or at your home.
During the first 15 minutes of this visit, we will discuss the study with you in detail, ask you to sign a consent form, and conduct a basic medical assessment to confirm your suitability for the study. As part of this, we will then measure blood pressure on both of your arms and ankles. You are likely to experience a small degree of discomfort at the arm and ankle whilst the blood pressure cuffs are blown up. We will need to record your current medications, so please bring a list of all the medications that you are taking. We will also measure and take a photo of your ulcer to follow through the healing process. Photos will be taken again at each assessment session until your ulcer is completely healed.
If you are suitable for the study, the remaining 25 minutes will be for completing various assessments of your health and fitness. First, you will be asked to complete some questionnaires about your health and quality of life. Second, we will assess your physical fitness using three simple tests: (1) 2-minute corridor-walking test. Here you will be asked to walk up and down a corridor and cover as far a distance as possible in 2 minutes; (2) 30-second chair-stand test. Starting from a seated position, we will record the number of times you can stand up fully in 30 s with your arms folded across your chest; (3) Sit and reach test. Starting from sitting at the edge of a chair, with your legs out straight in front, we will ask you to reach as far forward as possible towards your toes. These fitness tests might make you feel tired for a few minutes.
In the final part of the session, you will receive instructions on how to complete a brief ulcer diary, which we will give you. The information you provide in this diary will allow us to follow how your ulcer and related symptoms change over time.
Visits 2 and 3 (13 weeks and 6 months after enrolment): Follow-up assessment (30 minutes), Sheffield Hallam University or at your home.
During these visits, you will be asked to repeat the assessments that were completed in the first visit (questionnaires, blood pressure and ulcer size measurements, physical fitness tests). You will also be asked to have your ulcer diary in-hand so that we can take a copy of it.
What are the possible advantages of taking part?
You may or may not benefit directly from this study. People who undertake regular exercise training often become fitter and healthier, so you might experience this if you are allocated to the exercise group. The trial will also give us useful information which may be of benefit to others in the future and aid the development of treatment for venous ulcers.
What are the possible disadvantages of taking part?
The procedures that we are using in this research are all well-established techniques which have been used in other patient groups in numerous research studies without any significant side effects being reported. Therefore, the only side effects that we would expect you to experience are the minor side effects associated with the test procedures described above.
Are there any expenses or payments involved?
If you take part in Phases 1 and 3 of the study you will receive £15 each time you participate in the focus groups and interviews (So £30 if you take part in both or £15 if you take in one of them). You will also receive £10 for your travelling expenses if you choose to visit us with your own transport.
If you take part in Phase 2 you will receive £7.5 for every visit that takes place outside your home.
Additionally, we will arrange a free permit for on-site parking should you choose to drive to an assessment taking place outside your home.
If I decide to participate, will my GP be notified?
With your consent, we will inform your family doctor that you are taking part in this study. If they know of any reason why you should not be included in the study, they will let us know and we will then discuss this with you to take a mutually-acceptable decision.
What if I change my mind during the study?
You are free to withdraw from the study at any time. If you decide to withdraw, we may ask you to consider attending one final assessment, but this is entirely optional. You can choose to leave the study at any time without having any further assessments. We would like to use all your data up to the point of withdrawal as this will help with our analysis. However, if you would prefer us not to use any of your data you may request for all your data to be removed from the study. A decision not to carry on with the study will not affect the quality of care you receive in any way.
Will anyone be able to connect me with what is recorded, collected and reported?
Sheffield Health and Social Care NHS Foundation Trust is the sponsor for this study based in the United Kingdom. The research team will be using information from you and/or your medical records to undertake this study in accordance with the Study Sponsor’s instructions 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 and Sheffield Health and Social Care NHS Foundation Trust will use your name, gender, date of birth, contact details, GP and next of kin details confidential 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, the Sheffield Health and Social Care NHS Foundation Trust and regulatory organisations may look at your medical and research records to check the accuracy of the research study. Sheffield Teaching Hospitals NHS FT will pass these details to Sheffield Hallam University along with the information collected from you and/or your medical records. The only people in Sheffield Hallam University and Sheffield Health and Social Care NHS Foundation Trust 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 and Sheffield Health and Social Care NHS Foundation Trust 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 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://shsc.nhs.uk/about-us/corporate-information/confidentiality-and-information-sharing/. This research study has been reviewed to ensure that participants are treated appropriately, and their rights respected.
It was approved by a Sheffield Hallam University research ethics UREC with Converis number ER5560707. Further information can be found at: at https://www.shu.ac.uk/research/ethics-integrity-and-practice
Furthermore, all research in the NHS is looked at by an independent group of people called a Research Ethics Committee to protect your safety, rights, wellbeing and dignity. Therefore, this study has also been reviewed by London Surrey NHS Research Ethics Committee.
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. Detailed information on this will be given in Part 2.
If the information in Part 1 has interested you and you are considering participation, please read the additional information in Part 2 before making any decision.
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 Mr. John Wolstenholme, the Sheffield Health and Social Care NHS Foundation TrustInformation Manager at [email protected], if you have a query about how your data is used by the research team, if you would like to report a data security breach (e.g. if you think your personal data has been lost or disclosed inappropriately), if you would like to complain about how the research team has used your personal data.
Alternately you can use the normal Trust complaints procedure and contact Ms Faye Mellors, PALS Advisor, Sheffield Health and Social Care NHS Foundation Trust, Tel 0114 275 8956, which will also be able to provide some independent advice on the study.
What if I am harmed?
If something goes wrong and you are harmed during the research study, there are no special compensation arrangements. If you are harmed because 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 the Research for Patient Benefit programme of the National Institute of Health Research. Sheffield Hallam University and Sheffield Health and Social Care NHS Foundation Trust are responsible for the conduct of the study. The investigators of this study will not receive any payment for conducting this research.
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