logo3Exploring the Feasibility of Implementing a Supervised Exercise Training and Compression Intervention in Patients with Venous Ulceration (FISCU)

What is the purpose of the study?

Lower-leg venous ulcers are a common complication of venous disease.  Venous ulcers 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’ physical function and quality of life.

Exercise training is an effective strategy for improving circulation and physical function.  Because of this, it has been suggested that exercise training might be a useful therapy for people with venous ulcers.  Currently little is known about the practicality and effectiveness of exercise training in this patient group.

The purpose of this study is to explore the practicality and effectiveness of supervised exercise training, in addition to compression therapy, in people with venous ulcers.

What will happen if I take part?

This study will take us approximately 36 months to complete but if you agree to take part in the study we will only ask for your help for a maximum of 12 months.  If you are eligible for the study and are happy to take part we will arrange for you to attend the Centre for Sport and Exercise Science at Sheffield Hallam University or the Human Performance Centre at the University of Lincoln for a screening visit (Participant can chose preferred location). 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. This appointment will take up to 90 minutes.

We would like to find out if it is practical and useful for people with venous ulcers to undertake supervised exercise training alongside compression therapy. In order to find this out, participants are randomly assigned to one of two groups.  Which group you are put in depends on chance and is rather like tossing a coin.  You will have an equal chance of being allocated to either group.  When the study is completed, the results are compared to see if there are any differences between the groups.  In this trial:

  • Half of the people enrolled will be invited to undertake 3 sessions of supervised exercise training each week for 12 consecutive weeks at a research facility at Sheffield Hallam University or at the University of Lincoln. Each session will last about 75 minutes and will involve a combination of endurance, muscle-strengthening and flexibility exercises, with the endurance exercise being treadmill walking or cycling or a combination of both (this will be chosen by you in collaboration with an experienced researcher who will guide and support you during the sessions).
  • The other half will receive basic advice about exercise, but no supervised training.

Whichever group you are in you will keep taking your normal treatment for your ulcer, for example, wearing compression stockings which you might have been given before you joined the study.

Taking part would also mean coming to the research facility at Sheffield Hallam University or the University of Lincoln for 3 visits over the next 12 months – one at the start of the study, the second after 12 weeks, and the third after 12 months.  These visits can be scheduled at a time to suit you.  We will also contact you at 6 months to ask you to complete some questionnaires.

 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?

We will provide a £5 contribution towards your travelling expenses for each visit, including your exercise visits if you are allocated in the exercise group.  You will receive transport payments at visit 2 (week 13) and visit 3 (12 months).  Additionally, we will arrange a free permit for on-site parking should you choose to drive.

If you are interested in taking part or would like more information, please use the contact details below: 

Emma McIntosh (Research Assistant)        
Tel: 0114 225 2262
Email: e.mcintosh@shu.ac.uk