A Lower Leg Physical Activity Intervention for Individuals With Chronic Venous Leg Ulcers: Randomized Controlled Trial. 2020

Teresa J Kelechi, and Margaret A Prentice, and Martina Mueller, and Mohan Madisetti, and Alexey Vertegel
College of Nursing, Medical University of South Carolina, Charleston, SC, United States.

Individuals with venous leg ulcers (VLUs) suffer disproportionately with multiple chronic conditions, are often physically deconditioned, and demonstrate high levels of physical inactivity. 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. 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. 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 The technology became outdated quickly, making maintenance problematic.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. 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. ClinicalTrials.gov NTC02632695; https://clinicaltrials.gov/ct2/show/NCT02632695.

UI MeSH Term Description Entries
D007866 Leg The inferior part of the lower extremity between the KNEE and the ANKLE. Legs
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D009042 Motivation Those factors which cause an organism to behave or act in either a goal-seeking or satisfying manner. They may be influenced by physiological drives or by external stimuli. Incentives,Disincentives,Expectations,Disincentive,Expectation,Incentive,Motivations
D005081 Exercise Therapy A regimen or plan of physical activities designed and prescribed for specific therapeutic goals. Its purpose is to restore normal musculoskeletal function or to reduce pain caused by diseases or injuries. Rehabilitation Exercise,Remedial Exercise,Therapy, Exercise,Exercise Therapies,Exercise, Rehabilitation,Exercise, Remedial,Exercises, Rehabilitation,Exercises, Remedial,Rehabilitation Exercises,Remedial Exercises,Therapies, Exercise
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014647 Varicose Ulcer Skin breakdown or ulceration in the drainage area of a VARICOSE VEIN, usually in the leg. Stasis Ulcer,Venous Ulcer,Venous Hypertension Ulcers,Venous Stasis Ulcers,Hypertension Ulcer, Venous,Hypertension Ulcers, Venous,Stasis Ulcer, Venous,Stasis Ulcers,Stasis Ulcers, Venous,Ulcer, Stasis,Ulcer, Varicose,Ulcer, Venous,Ulcer, Venous Hypertension,Ulcer, Venous Stasis,Ulcers, Stasis,Ulcers, Varicose,Ulcers, Venous,Ulcers, Venous Hypertension,Ulcers, Venous Stasis,Varicose Ulcers,Venous Hypertension Ulcer,Venous Stasis Ulcer,Venous Ulcers
D015444 Exercise Physical activity which is usually regular and done with the intention of improving or maintaining PHYSICAL FITNESS or HEALTH. Contrast with PHYSICAL EXERTION which is concerned largely with the physiologic and metabolic response to energy expenditure. Aerobic Exercise,Exercise, Aerobic,Exercise, Isometric,Exercise, Physical,Isometric Exercise,Physical Activity,Acute Exercise,Exercise Training,Activities, Physical,Activity, Physical,Acute Exercises,Aerobic Exercises,Exercise Trainings,Exercise, Acute,Exercises,Exercises, Acute,Exercises, Aerobic,Exercises, Isometric,Exercises, Physical,Isometric Exercises,Physical Activities,Physical Exercise,Physical Exercises,Training, Exercise,Trainings, Exercise

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