A Lower Leg Physical Activity Intervention for Individuals With Chronic Venous Leg Ulcers: Randomized Controlled Trial

Teresa J Kelechi, Margaret A Prentice, Martina Mueller, Mohan Madisetti, Alexey Vertegel, Teresa J Kelechi, Margaret A Prentice, Martina Mueller, Mohan Madisetti, Alexey Vertegel

Abstract

Background: Individuals with venous leg ulcers (VLUs) suffer disproportionately with multiple chronic conditions, are often physically deconditioned, and demonstrate high levels of physical inactivity.

Objective: The primary objective of this randomized controlled trial was to establish the feasibility of a mobile health (mHealth) physical activity exercise app for individuals with VLUs to improve lower leg function.

Methods: In a 6-week study, adults with VLUs were recruited from 2 wound centers in South Carolina, United States, and enrolled if they were aged 18 years or older with impaired functional mobility and an ankle-brachial index between 0.8 and 1.3. Participants were randomized 1:1 to receive evidence-based, phased, nonexertive physical conditioning activities for lower leg function (FOOTFIT) or FOOTFIT+ with an added patient-provider communication feature. The mHealth Conditioning Activities for Lower Leg Function app also provided automated educational and motivational messages and user reports. Foot movement on the VLU-affected leg was tracked by a Bluetooth-enabled triaxial accelerometer. The study was guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to assess the feasibility of reach, adherence, acceptability, implementation, and maintenance.

Results: A total of 24 patients were recruited, enrolled, and randomized in the study. Most patients reported difficulty following the protocol for exercising and using the accelerometer and mobile phone and did not use the provider contact feature. However, all patients were adherent to the 6-week exercise program more than 85% of the time for duration, whereas 33% (8/24) of patients adhered more than 85% for the frequency of performing the exercises. Across the three exercise levels, adherence did not differ between the two groups. Confidence limits around the difference in proportions ranged from -0.4 to 0.7. Providers in FOOTFIT+ were inconsistent in checking participant progress reports because of 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 The technology became outdated quickly, making maintenance problematic.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 the demonstrations of each level of exercise provided through the app.

Conclusions: The findings of this study suggest that despite initial interest in 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, mobile phones or tablets with larger screens, an app designed with larger graphics, automated reporting for providers, and more engaging user features.

Trial registration: ClinicalTrials.gov NTC02632695; https://ichgcp.net/clinical-trials-registry/NCT02632695.

Keywords: adherence; exercise; feasibility; leg ulcer; mHealth; physical activity; randomized controlled trial.

Conflict of interest statement

Conflicts of Interest: None declared.

©Teresa J Kelechi, Margaret A Prentice, Martina Mueller, Mohan Madisetti, Alexey Vertegel. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 15.05.2020.

Figures

Figure 1
Figure 1
Participant Consolidated Standards of Research Trials flowchart.

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