Physical Activity Interventions for Leg Ulcer Patients
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Cardiology, Gastrointestinal |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 55 - Any |
| Updated: | 9/9/2018 |
| Start Date: | April 2015 |
| End Date: | August 31, 2018 |
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.
(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+.
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+.
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
We found this trial at
1
site
101 E Wood St
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29303
(864) 560-6000
Phone: 864-560-1042
Spartanburg Regional Medical Center Spartanburg Regional is an integrated healthcare delivery system that provides care...
Click here to add this to my saved trials
