Using Smartphone Sensor Technology to Characterize Ambulatory Patterns of Participants With Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in SF-36 Physical Component Summary
研究概览
简要总结
The investigators plan to use smartphone and wearable sensor technology to characterize the activity patterns of participants with peripheral artery disease (PAD) (n=24) participating in a 12-week supervised exercise training (SET) program, and incorporate the resulting data into a web-based dashboard for participants and study staff.
详细描述
Participants in the proposed study will be current clinical participants in the SET program within Fairview. Participants will have a diagnosis of PAD and be ≥40 years of age (participants are diagnosed before they are referred to the SET program). Rate limiting comorbidities not associated with vascular disease (e.g., severe chronic obstructive pulmonary disease) will be exclusionary (for example). Age, sex, race, ethnicity, educational status, and smoking status at baseline will be recorded from cardiac rehabilitation intake forms. Eligible participants will be identified by study staff reviewing electronic medical records of patients who are enrolling into the SET program. University of Minnesota staff will travel to the urban and rural clinical rehabilitation sites to obtain informed consent at the participants first SET visit. They will then provide participants instructions and training for how to use the smartphone and app.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of atherosclerotic PAD and referred to hospital-based SET
- •Ability to complete an evaluation of physical function and walk on a treadmill
- •Resting ankle-brachial index (ABI) of ≤0.90 or stenosis ≥50% in a peripheral vessel or those with lifestyle limiting vascular-related claudication
- •Those with a resting ABI of 0.91-0.99 (borderline) who have completed an exercise-ABI assessment with a >20% drop compared to resting values
- •Those with ABI >1.40 who have had an abnormal toe-brachial index of ≤0.70
排除标准
- •Lower extremity amputation(s) which interfere(s) with walking on the treadmill.
- •Individuals with critical limb ischemia defined by ischemic rest pain or ischemic ulcers/gangrene on the lower extremities
- •PAD of non-atherosclerotic nature (e.g., fibromuscular dysplasia, irradiation, endofibrosis)
- •Females who are pregnant
- •Coronary artery bypass grafts or major surgical procedures within 6 months prior to screening
- •Individuals whose walking exercise is primarily limited by symptoms of chronic obstructive pulmonary disease, angina, or heart failure
- •Individuals who have had a myocardial infarction within 3 months prior to screening
- •Individuals who have had a transient ischemic attack or stroke 3 months prior to screening
- •Individuals with uncontrolled hypertension (≥180 systolic or ≥100 diastolic resting blood pressure) during screening
- •Poorly controlled diabetes defined as glycated hemoglobin >12%
- •Abnormal results of blood work not conducive to safely participating in an exercise trial (e.g., anemic, electrolyte abnormalities)
- •Inability to speak English
- •Other clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the study team, not stabilized or may otherwise confound the results of the study
结局指标
主要结局
Change in SF-36 Physical Component Summary
时间窗: 12 weeks
The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health). These subscores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.
Change in The Walking Impairment Questionnaire (WIQ) Speed Subcategory
时间窗: 12 weeks
In the Walking Impairment Questionnaire speed subcategory, participants are asked to rate the degree of difficulty walking one block at specific speeds, ranging from walking slowly to jogging, on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).
Change in The Walking Impairment Questionnaire (WIQ) Distance Subcategory
时间窗: 12 weeks
In the Walking Impairment Questionnaire distance subcategory, participants are asked to rate the degree of difficulty walking specific distances on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).
Peripheral Artery Disease Quality of Life (PADQOL) questionnaire
时间窗: 12 weeks
PADQOL is a 38-item survey assessing the quality of life of PAD patients. Items are scored on a scale of 1 (strongly agree) to 6 (strongly disagree). Total scores are sums of all 38 items with a range of 38 (normal quality of life) to 228 (quality of life is severely impaired).
Change in The Walking Impairment Questionnaire (WIQ) Stair-Climbing Subcategory
时间窗: 12 weeks
In the Walking Impairment Questionnaire stair-climbing subcategory, participants are asked to rate the degree of difficulty climbing a specified number of stair flights, ranging from 1 to 3 stair flights, on a graded scale of 0 to 4. A score of 0 indicates the inability to climb the flights specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).
Change in SF-36 Mental Component Summary
时间窗: 12 weeks
The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health). These subscores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.
次要结局
- Change in Six-Minute Walk Test (6-MWT) Claudication Onset Distance(12 weeks)
- Change in Ankle-Brachial Index (ABI) Assessment(12 weeks)
- Change in Six-Minute Walk Test (6-MWT) Maximal Distance(12 weeks)
- Change in Six-Minute Walk Test (6-MWT) Claudication Onset Time(12 weeks)
- Short Physical Performance Battery (SPPB)(12 weeks)