Testing the feasibility of a co-designed intervention comprising self-managed, home-based exercise training with embedded behavioral support and compression therapy for people with venous leg ulcers, receiving treatment at home (FISCU-II)

Background

Venous leg ulcers heal slowly, are painful and costly for healthcare systems, and also affect patients’ quality of life. Previous work suggests that supervised exercise training used in combination with compression therapy may offer clinical benefits. However there is a large population of people with VLUs, who are unable to access such an intervention due to frailty and age.

Objective

Our primary aim was to assess the feasibility of FISCU Home (a co-designed, 12-week home-based, self-managed, lifestyle programme based on exercise and behaviour support), as an adjunct therapy to compression in people with VLUs.

Methods

Forty people with VLUs (121 excluded/22 refused), receiving treatment at home, were recruited from community nursing and tissue viability teams and newspaper advertisement. Participants were randomized 1:1 either to exercise with behaviour support (thrice/week) plus compression therapy or compression only. The feasibility of the programme was assessed using progression criteria that included exercise attendance rate, loss to follow-up, patient preference(s) and adverse events. Baseline assessments were repeated at 12 weeks and 6 months. Secondary outcomes (i.e., ulcer recurrence, healing rate and healing time) were also documented at these intervals. Intervention and healthcare utilization costs were calculated.

Results

Recruitment rate was 65%, while 75% of the exercise group participants attended all scheduled exercise sessions. All participants completed their compression therapy. No serious adverse or exercise-related adverse events were reported. Median ulcer healing time was shorter in the exercise group (29 (7-108) vs 42 (6-116) weeks).

Conclusions

The feasibility and acceptability of both a home-based, exercise-based, lifestyle intervention in conjunction with compression therapy, and the study procedures are supported.

A Home-Based Treatment Approach based on Lifestyle Modification to Heal Venous Leg Ulcers (VLUs)

What is it about?

This study explored the feasibility of a self-managed, home-based lifestyle program based on exercise and behavioral support (called “FISCU Home”) as an additional treatment to compression therapy for individuals with venous leg ulcers (VLUs). VLUs are painful, slow-healing wounds that impact the quality of life and are costly for healthcare systems. Many VLU patients, particularly older adults or those who are frail, cannot access traditional supervised exercise programs. The FISCU Home intervention was co-designed with patients and tailored to their needs. It included self-managed exercise sessions three times per week over 12 weeks, with additional lifestyle support offered from an exercise specialist through frequent home visits and phone calls. Participants were divided into two groups: one received the lifestyle program alongside compression therapy, while the other group only received compression therapy. The study assessed factors like patient recruitment, adherence to the program, safety, and healing outcomes over six months. Results showed that the program was safe, feasible, and had high adherence, with 75% of participants completing all sessions. The lifestyle group had a shorter median healing time (29 weeks compared to 42 weeks in the control group) and showed improvements in physical health and quality of life.

Why is it important?

VLUs affect a growing population, particularly older adults, with up to 30% of cases not responding well to compression therapy alone. Traditional treatments often fail to address underlying issues like poor circulation and lack of mobility, which contribute to the chronic nature of these ulcers. This study demonstrates that a home-based program can overcome barriers faced by frail or homebound individuals who cannot access clinic-based interventions. The findings suggest that integrating tailored exercise and lifestyle advice with compression therapy could improve healing rates and reduce healthcare costs. Additionally, the program’s success in retaining participants and preventing adverse effects makes it a promising model for future large-scale studies. If implemented widely, this intervention could potentially enhance the quality of life for patients, reduce the burden on caregivers, and offer cost-effective solutions for healthcare systems.

Plain Language Title

A Home-Based Treatment Approach based on Lifestyle Modification to Heal Venous Leg Ulcers (VLUs)

Key Takeaways:

1. Home-based exercise is feasible and safe for VLU patients.

2. High adherence rates highlight patient engagement, with the programme being also safe and well-tolerated.

3. Results suggest shortened healing time compared to compression-only therapy.

4. Findings also indicate that our programme can improve physical health and reduce healthcare costs.

5. As this was a small-scale study, further large-scale trials are needed to confirm these findings.