Abstract
BACKGROUND: Venous ulcers negatively affect quality of life and generate high health care costs. Physical activity may improve their evolution; however, the evidence is limited and heterogeneous. OBJECTIVE: To evaluate the effectiveness of a structured physical activity intervention as an adjunct treatment for the complete healing of venous ulcers in primary care at 3 and 6 months of follow-up. DESIGN: This was a randomized, pragmatic clinical trial with 6 months of follow-up. METHODS: Between February 2021 and June 2023, 44 people with a diagnosis of venous ulcers and an ankle-brachial index between 0.8 and 1.3 were recruited from 13 health centres in Madrid. Both groups received standard treatment. The intervention group also received a structured educational intervention of physical exercise and daily walking guidelines. The main outcomes were complete healing (RESVECH 2.0 scale) and time to healing (days). The secondary variables included degree of healing, ulcer area, pain, adherence, and variables related to healing and prognosis. Data were collected at the beginning and at 3 and 6 months of follow-up. Survival analysis (Kaplan‒Meier and Cox) was performed to measure the effectiveness of the treatments, as was intention-to-treat analysis. RESULTS: At 3 months, 77.3% [95% CI 54-91] of the patients in the intervention group and 68.2% [95% CI 45-85] of those in the control group achieved complete healing, without statistically significant differences between groups. Overall adherence to the intervention was low; only 20% and 46% of the participants reached the level of compliance established in the first two visits, which progressively decreased. CONCLUSIONS: The Active Legs programme showed a positive effect on the healing of venous ulcers in primary care. TRIAL REGISTRATION: http://NCT04039789. [https://ClinicalTrials.gov]. 11/07/2019.