Exercise-Induced Ankle-Brachial Index Dynamics as a Predictive Marker in Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 85
- 试验地点
- 1
研究概览
简要总结
The goal of this observational study or clinical trial is to investigate how exercise can affect different areas of a person's life, especially those people with vascular disease. This is important because exercise can be beneficial for people with vascular disease. The study could include any of the following: those aged 65 years of age and older, between the ages of 50-64 who smokes, has diabetes, high blood pressure, high cholesterol, or has a family member with vascular disease, between the ages of 18-49 with diabetes and one other factor listed above, or those with vascular disease. The main question[s] it aims to answer is if exercise testing can better predict vascular disease.
The following research questions will be addressed in this study:
- Does baseline ABI influence the magnitude and recovery trajectory of ABI following an acute bout of exercise across a spectrum of vascular function?
- What association does exercise-induced ABI changes have on patient-reported outcomes of quality of life and intermittent claudication?
- Do functional outcomes of gait speed, time to claudication, gait variables related to rest breaks in 6MWT, and walking distance predict the magnitude of exercise-induced ABI reduction?
Participants will :
- complete various questionnaires and a routine screening for vascular disease *walk for 6 minutes at your own pace
- additional vascular screening tests will be performed.
详细描述
The purpose of this study is to examine if dynamic, exercise induced changes in the ankle- brachial index (ABI) are associated with pain, quality of life, and functional outcomes to better characterize peripheral vascular disease.
Individuals will be screened for eligibility if they meet the inclusion criteria. All data collection will occur during a single laboratory visit. It is anticipated the research study will take 1-2 hours, with 1 visit total to complete the study.
The primary study endpoint is to assess the use of the ankle-brachial test after exercise. This will be accomplished when the proposed number of subjects have been enrolled and completed the proposed protocol. Secondarily, the study may be stopped due to lack of funding. The final endpoint will be the completion of all data analysis including long-term follow up data and preparation for dissemination of the research findings.
The primary safety endpoint will occur if the study participant is unable to complete any part of the protocol.
All participants will give written consent to participate in the study. Participants will be instructed to refrain from alcohol, caffeine, nicotine, and exercise for at least one hour prior to testing to minimize confounding physiological effects. Testing will occur in a temperature-controlled environment maintained between 74-78°F (23-26°C) to ensure thermal stability and vascular consistency. Participant information including age, body mass index (BMI), diabetes status, past medical history, smoking history, and a list of current medications will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •individuals over 65 years of age
- •individuals aged 50-64 with a risk factor for atherosclerosis including diabetes mellitus, history of smoking, hyperlipidemia, hypertension, or family history of peripheral arterial disease (PAD)
- •individuals aged 18-50 with diabetes mellitus and one additional risk factor for atherosclerosis as noted above, or
- •individuals with known atherosclerotic disease in another vascular bed including the coronary, carotid, subclavian, renal, or mesenteric artery stenosis, and individuals with known PAD
排除标准
- •contraindications to brachial and/or ankle pressure measurement including history of deep vein thrombosis
- •lymphedema of the arms or legs
- •history of mastectomy or current leg ulceration preventing placement of a blood pressure cuff around the lower leg
- •an inability to lie in a supine position for 15 min
- •self-reported inability to walk for 6 minutes
- •severe cardiac or pulmonary disease limiting exercise
- •inability to obtain a Dopplerable pulse
- •noncompressible arteries (ABI >1.4)
- •those unable to consent