Clinical trial NCT02632695: Physical Activity Interventions for Leg Ulcer Patients
Official title: Physical Activity Interventions for Leg Ulcer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Ulcers
Venous Ulcers
Varicose Ulcers
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2015-12-17
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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+.

Eligibility criteria: 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

Primary outcomes:
measure: FOOTFIT feasibility
timeFrame: 6 weeks
measure: FOOTFIT reach
timeFrame: 6 weeks
measure: FOOTFIT technology implementation procedures
timeFrame: 6 weeks
measure: FOOTFIT acceptability
timeFrame: 6 weeks
Secondary outcomes:
measure: Efficacy on pain
timeFrame: 6 weeks
measure: Efficacy on foot strength
timeFrame: 6 weeks
measure: Efficacy on foot range of motion.
timeFrame: 6 weeks
measure: Efficacy on walking function.
timeFrame: 6 weeks
measure: Efficacy on walking performance
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Moby Madisetti, MS
role: STUDY_DIRECTOR
References:
citation: Kelechi TJ, Prentice MA, Mueller M, Madisetti M, Vertegel A. A Lower Leg Physical Activity Intervention for Individuals With Chronic Venous Leg Ulcers: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 May 15;8(5):e15015. doi: 10.2196/15015.