Physical Activity Interventions for Leg Ulcer Patients (FOOTFIT)

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.

Study Overview

• Status: Completed
• Conditions: Venous Ulcers; Leg Ulcers; Varicose Ulcers
• Intervention / Treatment: Device: FOOTFIT

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+.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FOOTFIT Plus; 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.	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.
Experimental: FOOTFIT; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FOOTFIT feasibility	Measure adherence by recording frequency and intensity of foot/toe movements reported in minutes.	6 weeks
FOOTFIT reach	Measure reach, recorded as qualitative documents on a log of how patients learned about the study.	6 weeks
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Efficacy on walking performance	The Six Minute Walk Test reported as distance in feet over six minutes time.	6 weeks

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Study Director: Moby Madisetti, MS, Medical University of South Carolina

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: December 1, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: Pro00043451

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No