The Effect of Standard Compression Adjuvant with a Tailored Exercise Training Program on Health-Related Quality of Life Outcomes in Treating Adults with Venous Leg Ulcer: A Randomized Controlled Trial

Abstract

Exercise training adjuvant to standard compression is considered to improve calf muscle pump dysfunction in venous leg ulcer (VLU) and subsequent healing. The objectives of this trial were to assess the effectiveness of a tailored exercise training intervention in addition to standard compression therapy on health-related quality of life and anticipating wound healing. Twenty-four VLU participants were recruited and randomly divided into 2 groups. The control group was prescribed conventional compression, and the intervention group received compression plus progressive tailored exercise training. The 14-item chronic venous disease quality of life questionnaire (CIVIQ-14) was used to assess improvement after treatment over time (0, 6, and 12 weeks). Intervention and control groups achieved wound closure for 11 (92%) and 7 (58%) patients. After adjusting for age, sex, and wound size at baseline, the exercise intervention group had 2 times the probability of complete wound healing in 12 weeks than those in the control group (risk ratio = 1.98, 95% CI= 1.01–3.72, P = .047). The primary outcome was the difference in CIVIQ-14 score in 3 dimensions and global index score per visit. The outcomes were evaluated by independent assessors. Demographic, comorbidities, and wound assessments were collected on enrollment. The overall adherence to exercise protocol was 71%. After adjusting age, sex, size of VLU, and CIVIQ score at baseline, the participants in the intervention group had the average global index scores and psychological scores increase at week 12 than those in the control group (21.2; 95% CI= 7.1–35.2, P = .005, and 13.5; 95% CI = 2.9–24.2, P = .044, respectively). Both groups showed similar improvement in the mean change in physical and pain scores within-group over time. Patients with combined conventional compression therapy with exercise training appeared to have a higher quality of life score in psychological and global scores than those with compression therapy alone.