JMIR Publications

ABSTRACT

Background:

Individuals with venous leg ulcers (VLUs) suffer disproportionally with multiple chronic conditions, are often physically de-conditioned and demonstrate high levels of physical inactivity.

Objective:

The primary objective was to establish the feasibility of a mobile health (mHealth) smartphone physical activity exercise application (app) for individuals with VLUs to improve lower leg function.

Methods:

In a 6-week pilot randomized controlled trial 24 adults with VLUs were recruited from two wound centers in South Carolina, USA and enrolled if they were 18 years of age or older with impaired functional mobility, and ankle brachial index (ABI) between 0.8-1.3. Participants were randomized 1:1 to either the control or intervention group. The mHealth app delivered daily evidence-based, phased, non-exertive physical conditioning activities for lower leg function to both groups, and provided automated educational/motivational messages and user reports. Foot movement on the affected leg was tracked by a Bluetooth enabled tri-axial accelerometer. Participants in the intervention group were additionally provided with the ability to communicate directly with their clinician, who was in turn able to monitor patient adherence and provide feedback. The study was guided by the RE-AIM framework to assess feasibility of reach, adherence, acceptability, implementation and maintenance. In a secondary aim, clinical outcomes were assessed for physical and mental function, foot strength, ankle range of motion, walking and depression.

Results:

Participants reported difficulty following the protocol for exercising, using the accelerometer and Smartphone, and did not use the provider contact feature. Providers were inconsistent in checking participant progress reports due to lack of time from competing work commitments. The technology became outdated quickly, making maintenance problematic. Participants said they would continue to exercise their foot and legs and liked being able to follow along with demonstrations of each level of exercise. The 5° increase benchmark set for range of motion was not achieved except for dorsiflexion of the left ankle (6.5° ± 11.7 over baseline, 95% CI, -14.8; 1.9) in the FOOTFIT group. There were no clinically meaningful changes noted in strength anticipated to improve by 10 lb/in2 for dorsiflexion and plantar flexion except for the right ankle (5.2 ± 7.4, 95% CI, 0.2; 10.2) in the FOOTFIT group. No other clinically relevant changes were noted for function, walking distance, depression or mental and physical health.

Conclusions:

Findings suggest that despite initial interest for using the app, several components of the program as originally designed had limited acceptability and feasibility. Future refinements should include the use of more modern technology including smaller wearable accelerometers, smartphones or tablets with larger screens, an app designed with larger graphics, automated reporting for providers, and more engaging user features. The study should be conducted over 12-weeks to allow for adequate time to measure intervention effects. Clinical Trial: ClinicalTrials.gov: NTC02632695; https://clinicaltrials.gov/ct2/show/NCT02632695?term=physical+activity+leg+ulcer&rank=1