The goal of this study is to test FOOTFIT and enhanced FOOTFIT+, home-based mobile health (mHealth) physical activity (PA) interventions for a minimally ambulatory, chronically-ill, population with leg ulcers. A highly sensitive clinically designed Bluetooth® enabled accelerometer and tracking device (BEAT) worn on the foot during a progressive and evidence-based non-exertive leg conditioning activities for lower leg function (CALF) captures minute foot movements and sends the data to a Smartphone. This six-week feasibility study will compare FOOTFIT to FOOTFIT+, with the added connectivity feature, to promote patient-provider communication, evaluate adherence to PA, and assess signals of efficacy on functional outcomes in a very low fitness population.
FOOTFIT is a study of a lower leg conditioning mHealth intervention for patients with venous leg ulcers. The aims are to compare two versions, one of which is enhanced (FOOTFIT+), to determine which has the greatest impact on physical activity adherence, patient-provider communication, and leg function. FOOTFIT and FOOTFIT+ share three components: 1) a low-cost, tri-axial Bluetooth® enabled highly sensitive accelerometer and tracking device (BEAT) worn on the foot during, 2) phased conditioning activities for lower leg function (CALF) tracked by a, 3) Smartphone that captures signals from BEAT, provides motivational messages, CALF instruction, and automated feedback on progress. Forty patients will be targeted in this six-week study, 20 of which will receive FOOTFIT and 20 FOOTFIT+.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
24
Individuals with venous leg ulcers will be instructed on physical activity movements for their lower legs to be performed over six weeks while wearing a foot based activity monitor (accelerometer) that will send them motivational messages and progress reports. For those in the FOOTFIT Plus group, individuals will have the option to communicate with their wound care provider via text messages, emails or phone calls.
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
FOOTFIT feasibility
Measure adherence by recording frequency and intensity of foot/toe movements reported in minutes.
Time frame: 6 weeks
FOOTFIT reach
Measure reach, recorded as qualitative documents on a log of how patients learned about the study.
Time frame: 6 weeks
FOOTFIT technology implementation procedures
Record on study log the number and types of problems encountered with the study nurses teaching participants to use the foot accelerometer technology, the number and types problems reported by patient, the number and types of recommendations made by the participant regarding the use of the accelerometer, and nurse or provider recommendations for changes to refine the foot accelerometer technology, and the number and types of refinements to the technology that were made.
Time frame: 6 weeks
FOOTFIT acceptability
Record on study logs the the number (frequency) and types of interactions such as phone calls, emails or texts, between the patient and provider regarding FOOTFIT+ including reasons (i.e., exercises, adverse events that are related to, and not related to the use of the accelerometer).
Time frame: 6 weeks
Efficacy on pain
Obtain estimates of variability for short-term functional impacts on pain using the numerical rating scale (NRS) as a single score.
Time frame: 6 weeks
Efficacy on foot strength
Obtain estimates of variability for short-term functional impacts on foot strength using the dynamometer and reported as pounds per square inch.
Time frame: 6 weeks
Efficacy on foot range of motion.
Obtain estimates of variability for short-term functional impacts on foot range of motion using the goniometer and reported in degrees.
Time frame: 6 weeks
Efficacy on walking function.
Obtain estimates of variability for short-term functional impacts on walking function using the Foot and Ankle Ability Measure and reported as a sum score.
Time frame: 6 weeks
Efficacy on walking performance
The Six Minute Walk Test reported as distance in feet over six minutes time.
Time frame: 6 weeks
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