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

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 The technology became outdated quickly, making maintenance problematic.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://clinicaltrials.gov/ct2/show/NCT02632695

Factors Influencing Adherence to mHealth Apps for Prevention or Management of Noncommunicable Diseases: Systematic Review

“…In contrast, low acceptability, lack of time, health problems, and lack of motivation had a negative impact [ 118 ]. The user characteristic of the female gender positively influenced adherence in a study about an app for a lower leg physical activity intervention for individuals with chronic venous leg ulcers [ 114 ]. Furthermore, in a study on an mHealth app targeting inflammatory bowel disease, it was found that old age, low level of education, and lack of perceived usefulness negatively affected adherence [ 115 ].…”

“…Monetary incentives such as vouchers, lottery tickets, or direct cash contributions were given to participants in 31 of the 97 included primary studies [ 30 , 33 , 44 , 45 , 47 , 48 , 51 , 53 , 56 , 61 , 62 , 64 , 65 , 68 - 72 , 77 , 81 , 88 , 90 , 98 , 101 , 104 - 106 , 108 , 109 , 114 , 116 ]. However, the qualitative synthesis did not yield results regarding the effect of such monetary incentives as an additional intervention component on adherence.…”

“…Approximately 43% (42/97) of studies from 9 different health domains reported a wide variety of user characteristics that affect adherence, including age, gender, place of residence, marital status, health status, treatment history, education, employment status, income, and work hours [ 26 - 28 , 33 - 38 , 40 , 47 - 50 , 54 , 56 , 58 , 60 , 64 , 66 , 67 , 73 - 75 , 77 - 79 , 85 , 86 , 88 , 89 , 95 , 98 , 100 , 102 , 106 , 108 , 114 , 115 , 118 , 119 , 122 ]. The quantitative analysis did not reveal significant effects of average age, gender distribution, or pre-existing conditions on adherence across all included apps.…”

Smart Wearable Systems for the Remote Monitoring of Selected Vascular Disorders of the Lower Extremity: A Systematic Review

“…The use of multi-electrode sensors placed in the dressing was also used to monitor ulcer progression through bioimpedance analysis [ 51 , 52 ]. Some projects focused on physical activity parameters by using footwear-based Bluetooth-enabled triaxial accelerometers paired with mobile phone applications in order to improve lower leg function and strengthen lower extremities in individuals with leg venous ulcers, also recurring to communication functionalities with clinicians [ 53 , 54 ]. Henricson et al (2021) [ 50 ] employed a moisture sensor placed on the patient’s dressings in order to detect moisture concerning the absorbing capacity of the dressings.…”

“…Disagreements were resolved through consensus involving the assessment of all four reviewers. The complete list of included articles is presented in the References section [ 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 ].…”