Who is the funder?
NIHR Research for Patient Benefit.
What is the grant award?
£290,390.
Who is involved?
Sheffield Health and Social Care NHS Foundation Trust, Sheffield Hallam University, Sheffield Teaching Hospitals NHS Foundation Trust and Nottingham CityCare Partnership CIC.
Project start
July 2019.
Project end
August 2022.
Study summary
Venous leg ulcers (VLUs) affect almost 400,000 UK people over the age of 65. These are triggered by inadequate blood flow through the veins causing pain, mobility restrictions, devastation and social isolation. Each VLU costs up to £7.6K per year to the NHS while annual healthcare costs are up to £900 million.
Compression therapy (usually stockings or bandages) are often used to treat VLUs: although healing rates are good, ulcers often return. Moreover, many remain open for up to 1 year, needing about 50 visits to heal. Consequently, supportive therapies to compression are needed to reduce healing times.
Exercise may provide an answer. We recently completed a small study, examining if it was possible to use a 12-week, community-based exercise programme, along with compression therapy, to treat VLUs. We showed that the programme was safe, participants enjoyed it and were attending their sessions, being also happy to complete their assessments. The programme also offered reduced healing times and cost savings to the NHS of up to £875 per ulcer. Nevertheless, the programme didn't seem to be accessible for 40-50% of this group; these receive treatment at home and could otherwise do the exercises. Therefore, before embarking to a full-scale study to explore the clinical benefits and calculate the costs of a wider programme implementation, we need to design and explore the practicality of a home-based exercise programme, which would be offered to those who cannot travel. This is worth trying, as our findings indicate that 74% of house-bound people with VLUs would willingly try it.
Our 2-phase, Sheffield-based study will last 36 months. In phase 1, people with VLUs will help us design the home-based exercise programme via round-table discussions, interviews and a workshop. In phase 2, we will recruit 40 people with VLUs, who have treatment at home and although cannot travel, can do some flexibility, stretching and chair-aerobics exercises. Following assessments (measuring ulcer sizes, fitness, quality of life and associated costs among others), participants will be placed into one-of-two groups by a computer: one group will follow the phase 1-defined, home-based exercise programme and have standard at-home compression therapy; the other will receive compression therapy only. All participants will complete 3 home-based assessment sessions: initially at recruitment, then at the intervention end and finally 6 months after group allocation. We will also talk to 18 participants and 10 healthcare professionals, to hear about their intervention experience.
People with VLUs have helped us develop this grant application. They will also help us to: i) design the home-based programme, ii) best-manage the study and iii) interpret and publicise our findings. Upon completion, we will move to a full-scale study, which will provide a solution to this costly and devastating health problem.
Neurodegenerative disease (ND) is an umbrella term for a range of conditions which primarily affect the brain neurons. It includes dementias, Parkinson's disease, Prion and Motor neurone diseases, Huntington's disease, spinocerebellar ataxia and Spinal muscular atrophy.
Almost 20% of those people who receive "at home" treatment for VLUs, live with NDs as well. Our experience suggests that people who live with early-stage NDs are either reluctant to participate or aren't referred to the study, despite the potential clinical benefits, because of their condition. As we need to better understand and overcome the specific challenges faced by them in following the programme, we will specifically engage with 6-8 people with NDs and their carers to adapt it, in order to support them in being able to follow the programme to completion. People in this special sub-study, which will run in parallel to the main one, will conform to all study inclusion criteria and will help us adapt the programme and its delivery. They will also follow a 1-month "crash-course" of the adapted programme and at the end will let us know what went well and what didn't. Once completed, this special sub-study will give us an idea as of how to approach and implement, our exercise programme to wider VLU clinical groups, looking after them in the best possible way.