Physical Activity Interventions for Leg Ulcer Patients

Venous Ulcers Clinical Trial

— FOOTFIT  

Official title:

Physical Activity Interventions for Leg Ulcer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632695
• Other study ID #: Pro00043451
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: August 31, 2018

Study information

• Verified date: May 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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+.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Leg Ulcers
• Ulcer
• Varicose Ulcer
• Varicose Ulcers
• Venous Ulcers

Intervention

Device:
• FOOTFIT
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.

Locations

Country	Name	City	State
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FOOTFIT feasibility	Measure adherence by recording frequency and intensity of foot/toe movements reported in minutes.	6 weeks
Primary	FOOTFIT reach	Measure reach, recorded as qualitative documents on a log of how patients learned about the study.	6 weeks
Primary	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.	6 weeks
Primary	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).	6 weeks
Secondary	Efficacy on pain	Obtain estimates of variability for short-term functional impacts on pain using the numerical rating scale (NRS) as a single score.	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	Efficacy on walking performance	The Six Minute Walk Test reported as distance in feet over six minutes time.	6 weeks