Venous Leg Ulcers and exercise

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. Nevertheless, there are some important steps to take before we start using exercise as a part of the therapeutic journey for people with venous ulcers.

Firstly, there hasn’t been a study up to now, which would assess whether it is feasible and practical for an exercise programme to become part of the treatment regime for this clinical group.
Then, we don’t know if such a programme would be both clinically and cost effective. In other words we don’t know whether using it, would reduce ulcer healing time or ulcer size, if it would be economically-viable for a national healthcare system to use it and whether it would have a positive impact on people’s quality of life.

Taking one step at a time (and in attempt to avoid wasting money on a big study if things didn’t go according to evidence), the purpose of this study was to explore the practicalities of implementing such an intervention, as well as gathering evidence that would be useful in a big trial. This included among others pilot data which would help us determine the clinically-important targets of a future large trial as well as attendance and completion rates of exercise sessions by exercise group participants.

What did we do, during our study

The study was a collaboration between Sheffield Hallam University, Sheffield Teaching Hospitals NHS Foundation Trust and the University of Lincoln, sponsored and supported by Sheffield Health and Social Care NHS Foundation Trust and funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB).

All study participants were randomly allocated to one of the two study groups. In the first one, participants followed a supervised exercise training programme in addition to standard medical care, while in the second one, they received standard care only. Those allocated to the exercise programme were required to take part in 3 training sessions per week for 12 weeks at Sheffield Hallam University. The sessions involved a combination of endurance, muscle-strengthening and flexibility exercises. Both groups of participants undertook a baseline assessment, a 3 month follow-up and 12 month follow-up.

We also interviewed a proportion of our study participants about their study experiences, aiming to gather participants’ perspectives of the exercise intervention and their overall treatment experience.

What did we find out

Seventy‐two per cent of the exercise group participants attended all scheduled exercise sessions, while only 5% of the study participants didn’t turn up for the follow-up assessments. No serious adverse events and only two exercise‐related adverse events (both increased ulcer discharge) were reported.

At 12 months, ulcer healing time was lower in the exercise group (13 vs. 34·7 weeks).

The average NHS costs were lower in the exercise group (approx. £813 against £2299 for the control group).

Analysing the data collected during the exercise sessions, showed that people with venous ulcers could safely follow a supervised exercise programme incorporating moderate-intensity aerobic, resistance, and flexibility exercises, improving the number and duration of the exercises that they completed, with time, achieving an excellent level for both their intensity (100% for aerobic and 91% for resistance exercises) and duration (81% for aerobic and 93% for flexibility exercises) targets.

Furthermore, the study of the small veins of people with venous leg ulcers, before and after the exercise programme, revealed a major improvement in their functionality, both in relation to their inner vein lining and the way that smooth muscle works.

Finally, our study also found that an exercise intervention was viewed by participants as positive, acceptable, and feasible while living with a venous leg ulcer. An individualised and supervised exercise programme was key to build confidence to exercise.

What will be the impact of our study?

The main aim of this study wasn’t to change clinical practice; it was to inform a bigger study, which would aim to see if the exercise programme that we develop and propose is, clinically- and cost- effective.

This doesn’t sound very exciting, but it is: our study was the first to determine that a supervised, group-mode, exercise programme based on aerobic, resistance and flexibility exercise can actually be delivered, being enjoyed by its participants. This actually broke a lot of taboos for this clinical population, as it was considered by many that this group can’t enjoy or benefit from exercise as others.

It also showed quite clearly, why a simply calf-raising exercise programme couldn’t work – it is all down to how aerobic exercise helps the inner vein lining and the smooth muscle cells of our small veins in the legs.

Finally the collected data suggests that there are clinical and financial benefits for both people with venous leg ulcers and the national healthcare systems to be taken. But these will have to be assessed properly in a larger trial.

Our study publications

Our study protocol:
Supervised exercise training as an adjunctive therapy for venous leg ulcers: study protocol for a randomised controlled trial.
Tew GA, Michaels J, Crank H, Middleton G, Gumber A, Klonizakis M.

How aerobic exercise affects the function of small veins in people with venous ulcers:
Effects of supervised exercise training on lower-limb cutaneous microvascular reactivity in adults with venous ulcers.
Tew GA, Gumber A, McIntosh E, Kesterton S, King B, Michaels JA, Klonizakis M.

How did our study participants improve their exercise performance during the course of the programme:
Exercise fidelity and progression in a supervised exercise programme for adults with venous leg ulcers.
Klonizakis M, Gumber A, McIntosh E, King B, Middleton G, Michaels JA, Tew GA.

Our study participants’ views and experiences of the programme:
Participant experiences in a feasibility trial of supervised exercise training in adults with venous leg ulcers: A qualitative study.
Kesterton S, Crank HJ, Tew GA, Michaels J, Gumber A, McIntosh E, King B, Klonizakis M.

The main publication for our study:
Supervised exercise training as an adjunct therapy for venous leg ulcers: a randomized controlled feasibility trial.
Klonizakis M, Tew GA, Gumber A, Crank H, King B, Middleton G, Michaels JA.

Before you go

The Venous Leg Ulcers and exercise study was funded by the National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) Programme (grant number: PB-PG-0213-30029). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

Visit our dedicated project pages to find more about the study.