Physical Activity Interventions for Leg Ulcer Patients (FOOTFIT)

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Varicose Ulcers; Leg Ulcers; Venous Ulcers

Treatments: Device: FOOTFIT

Study type: Interventional

Funder types: Other

Identifiers

NCT02632695

Pro00043451

Details and patient eligibility

About

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.

Full description

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+.

Enrollment: 24 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active venous leg ulcer
• Ankle brachial index 0.80 to 1.3 mmHg, a measure of arterial sufficiency
• Sedentary-able to only walk a few steps at a time or not farther than 10 feet
• Not currently exercising or participate in a PA or physical therapy program
• Receives at least weekly wound care anticipated to last for at least six weeks from start of study
• Able to don accelerometer - if unable to apply independently, has assistance from other
• Capable of using Smartphone

Exclusion criteria

• Co-morbid conditions such as stroke (limits ankle function)
• Ulcer from other causes (arterial, diabetic, trauma, surgery)
• Documented cognitive impairment (MiniCog)
• No 3G service in area where patient resides

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

FOOTFIT Plus

Experimental group

Description:

The intervention consists of: 1) a prescribed, evidence-based, phased, non-exertive physical activity conditioning activities for lower leg function (CALF) movements that are to be performed daily at home; 2) a low-cost, tri-axial Bluetooth® enabled highly sensitive motion-sensing accelerometer and tracking device (BEAT) worn on the foot during CALF to capture frequency and intensity of foot movements; and 3) a Smartphone that receives foot movement data, provides automated educational/motivational messages, and reports and allows regular communication with the wound care provider on progress.

Treatment:

Device: FOOTFIT

FOOTFIT

Experimental group

Description:

The intervention consists of: 1) a prescribed, evidence-based, phased, non-exertive physical activity conditioning activities for lower leg function (CALF) movements that are to be performed daily at home; 2) a low-cost, tri-axial Bluetooth® enabled highly sensitive motion-sensing accelerometer and tracking device (BEAT) worn on the foot during CALF to capture frequency and intensity of foot movements; and 3) a Smartphone that receives foot movement data, provides automated educational/motivational messages, and reports. There is not regular communication with the wound care provider on progress.

Treatment:

Device: FOOTFIT