Physical Activity Interventions for Leg Ulcer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- FOOTFIT feasibility
研究概览
简要总结
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.
详细描述
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+.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
FOOTFIT feasibility
时间窗: 6 weeks
Measure adherence by recording frequency and intensity of foot/toe movements reported in minutes.
FOOTFIT reach
时间窗: 6 weeks
Measure reach, recorded as qualitative documents on a log of how patients learned about the study.
FOOTFIT technology implementation procedures
时间窗: 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.
FOOTFIT acceptability
时间窗: 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).
次要结局
- Efficacy on pain(6 weeks)
- Efficacy on walking function.(6 weeks)
- Efficacy on foot strength(6 weeks)
- Efficacy on foot range of motion.(6 weeks)
- Efficacy on walking performance(6 weeks)
研究者
Teresa Kelechi
Professor
Medical University of South Carolina