Physical Activity Interventions for Leg Ulcer Patients

NCT02632695 | Completed DMC

• 1 other identifier: Pro00043451
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leg Ulcers; Venous Ulcers; Varicose Ulcers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Efficacy on pain

  6 weeks

• Efficacy on foot strength

  6 weeks

• Efficacy on foot range of motion.

  6 weeks

• Efficacy on walking function.

  6 weeks

• Efficacy on walking performance

  6 weeks

Study Arms (2)

FOOTFIT Plus

EXPERIMENTAL

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

FOOTFIT

EXPERIMENTAL

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

Interventions

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.

FOOTFIT; FOOTFIT Plus

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Related Publications (1)

• 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.

  PMID: 32412419 DERIVED

MeSH Terms

Conditions

Leg Ulcer; Varicose Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Moby Madisetti, MS

  Medical University of South Carolina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 17, 2015
• Study Start: April 1, 2015
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-05

Locations

US (1)