FOOTFIT Physical Activity mHealth Intervention for Minimally Ambulatory Individuals With Venous Leg Ulcers

Abstract

PURPOSE: The purpose of this study was to investigate the use of an mHealth application (app), self-management physical activity intervention FOOTFIT with an added patient-provider connectivity feature (FOOTFIT+), that was designed to strengthen the lower extremities of minimally ambulatory individuals with venous leg ulcers (VLUs). DESIGN: Randomized controlled trial. SUBJECTS AND SETTING: Twenty-four adults 18 years and older with VLUs being treated in 2 wound clinics in the Southeastern United States participated in this study. METHODS: Preliminary estimates and 95% confidence intervals for the medians of short-term functional impacts on foot function, strength, ankle range of motion, walking capacity, depression, and physical functioning were obtained pre- and postassessment after the 6-week intervention trial. RESULTS: There were negligible changes in either group for foot function. It is noted that both groups experienced substantial foot and ankle impairment at baseline. The greatest improvement in range of motion was noted in the FOOTFIT group for dorsiflexion of the right ankle (4.6 ± 5.22 lb/in2 over baseline) whereas strength decreased in both ankles for dorsiflexion and plantar flexion in the FOOTFIT+ group. No improvements were noted in walking distance or physical health for FOOTFIT (slight decrease −2.9 ± 5.6) and FOOTFIT+ (slight increase 3.0 ± 6.6) during the 6-week study period. CONCLUSIONS: In a minimally ambulatory population with VLUs, our mHealth FOOTFIT intervention composed of progressive exercise “boosts” demonstrated minimal short-term effects. We recommend engagement with the app for a longer period to determine longer-term outcomes of lower extremity function.

Effects of physical activity as an adjunct treatment on healing outcomes and recurrence of venous leg ulcers: A scoping review

“…However, another study had the opposite opinion 59 and reported that the ability of diseases‐specific tools to identify whether the changes in health‐related QoL caused by open ulcers and/or underlying causes were unclear. We did not identify any obvious differences between studies adopting generic instruments and diseases‐specific QoL instruments, and the QoL scores in intervention groups increased moderately after receiving PA/exercise interventions 44,46,49,51 . Overall, there was little variability in the instruments and metrics used to evaluate key outcomes of interest.…”

“…One study found a ‘significant difference’ in QoL scores between the intervention group and the control group on day 90 ( p = 0.03); however, supportive data were not provided 49 . One other study reported increased QoL scores in intervention group after receiving foot/ankle range of motion exercises 46 …”

“…More than half ( n = 11) of PA/exercise programmes were conducted in the home environment without supervision 37,38,41,42,44–49,52 . Three studies utilised a small group format ( n = 4 participants per group) that also involved direct supervision by a qualified exercise physiologist 43,47,51 .…”

“…While most studies reported the effect of PA/exercise interventions on ulcer healing status, the impact on ulcer recurrence has rarely been investigated. Only one study measured ulcer recurrence rates 12 months following completion of an intervention involving resistance and aerobic exercise/walking training components; however, no clinical difference was detected (intervention group: 12% vs. control group: 5%) 46 . The lack of evidence relating to VLU recurrence has been previously identified 18,22,23 and remains a topic of unmet need.…”

“…Participants were asked to take 10,000 steps per day More than half (n = 11) of PA/exercise programmes were conducted in the home environment without supervision. 37,38,41,42,[44][45][46][47][48][49]52 Three studies utilised a small group format (n = 4 participants per group) that also involved direct supervision by a qualified exercise physiologist. 43,47,51 A summary of PA interventions is presented in Table 3, with additional details (in accordance with CERT recommendations) provided in Supporting Information S5.…”