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Completed

NCT Number: NCT02632695

Physical Activity Interventions for Leg Ulcer Patients

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.

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Key information

Conditions

Leg Ulcers Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Ulcers Varicose Veins Vascular Diseases Venous Ulcers

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

About this study

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+.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FOOTFIT

Device

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.

Primary outcomes

  1. FOOTFIT feasibility

    Time frame: 6 weeks

    Measure adherence by recording frequency and intensity of foot/toe movements reported in minutes.

  2. FOOTFIT reach

    Time frame: 6 weeks

    Measure reach, recorded as qualitative documents on a log of how patients learned about the study.

  3. FOOTFIT technology implementation procedures

    Time frame: 6 weeks

    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.

  4. FOOTFIT acceptability

    Time frame: 6 weeks

    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).

Secondary outcomes

  1. Efficacy on pain

    Time frame: 6 weeks

    Obtain estimates of variability for short-term functional impacts on pain using the numerical rating scale (NRS) as a single score.

  2. Efficacy on foot strength

    Time frame: 6 weeks

    Obtain estimates of variability for short-term functional impacts on foot strength using the dynamometer and reported as pounds per square inch.

  3. Efficacy on foot range of motion.

    Time frame: 6 weeks

    Obtain estimates of variability for short-term functional impacts on foot range of motion using the goniometer and reported in degrees.

  4. Efficacy on walking function.

    Time frame: 6 weeks

    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.

  5. Efficacy on walking performance

    Time frame: 6 weeks

    The Six Minute Walk Test reported as distance in feet over six minutes time.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Acronym: FOOTFIT

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 17, 2015
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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