Feasibility of an Exercise Intervention in Patients with Venous Ulcers
Research type
Research Study
Full title
Exploring the Feasibility of Implementing a Supervised Exercise Training and Compression Hosiery Intervention in Patients with Venous Ulceration (FISCU)
IRAS ID
146645
Contact name
Markos Klonizakis
Contact email
Sponsor organisation
Sheffield Health and Social Care NHS Foundation Trust
Research summary
Venous ulcers can cause pain, impaired mobility, and reduced quality of life (QoL). Treatment of venous ulcers places a huge financial burden on the National Health Service (£198-£400 million per year).
Compression hosiery is currently the most common treatment for venous ulcers. However, ulceration recurrence rates are high. Therefore, alternative therapies need to be pursued.
Supervised exercise training involving a combination of aerobic and resistance exercises might be useful adjunct to compression hosiery in the prevention and treatment of venous ulcers.
We are proposing a feasibility study for a definitive randomised controlled trial of a combined exercise and compression hosiery intervention to improve health outcomes in patients with newly-diagnosed venous ulcers. The main aim is to identify the primary outcome and estimated sample size for the subsequent trial. A secondary aim is to investigate the suitability of our intervention, primarily in terms of compliance, acceptability, and its impact on venous ulceration healing and QoL.
This is a single-centre, two-arm, parallel-group, randomised trial. Eighty patients with newly-diagnosed venous ulcers will be randomised 1:1 either to a 12-week exercise programme combined with compression stockings or compression only. The intervention group will undertake three sessions of supervised exercise each week, involving a combination of walking, cycling and leg strength and flexibility exercises.
Outcomes to be assessed before randomisation include physical fitness, health-related quality of life (EQ-5D-5L and VEINES questionnaires), ulceration size, calf circumference, time since ulcer-onset, previous operations, and history of deep vein thrombosis. Assessments will be repeated at the end of the exercise intervention period (12 weeks) and also 6 months and 1 year following randomisation, with healing rate and time, ulcer recurrence and infection incidents also documented. The costs associated with the intervention and healthcare utilisation will be calculated. Qualitative data will also be collected to assess participants’ experiences.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/0091
Date of REC Opinion
1 May 2014
REC opinion
Further Information Favourable Opinion