Physical Activity Interventions for Leg Ulcer Patients
Completed · Not applicable
Conditions studied: Leg Ulcers, Venous Ulcers, Varicose Ulcers
In brief
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.
Key facts
- Study ID
- NCT02632695
- Run by
- Medical University of South Carolina
- People needed
- 24
- Starts
- 2015-04-01
- Expected to finish
- 2018-08-31
- Last updated by the study team
- 2018-09-07
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
Full record on ClinicalTrials.gov
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