Cardiac Rehabilitation Program in Peripheral Arterial Disease
To Assess the Safety and Feasibility of a Structured Cardiac Rehabilitation Program in Patients With Peripheral Arterial Disease After Successful Revascularization Procedures: A Pilot Study.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Kansas
-
Kansas City、Kansas、美国、66160
- University of Kansas Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients with PAD post-revascularization (stent, angioplasty, or bypass).
- Patients must have the ability to ambulate safely without assistance and should not have plans for undergoing further staged revascularization procedures.
Exclusion Criteria:
- Below or above the knee amputation.
- Underlying cardiopulmonary or other co-morbidity that would be an exclusion under currently approved standard CR protocols at the University of Kansas Medical Center (KUMC).
- Unfavorable short term prognosis and limited life expectancy (<2 years)
- Awaiting a planned staged revascularization in same or other leg (patients will be eligible once no further procedures are planned).
- Prior history of having dropped out of CR without completing.
- Unwilling to consent for all aspects of CR or study participation.
- Unable to come for CR (this will exclude patients who live far away or have no means to travel to the CR facility).
- Pregnancy
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Cardiac Rehabilitation Group
Participants randomized to this group will undergo cardiac rehabilitation program.
|
Program will involve 36 sessions. These will be scheduled as 3 sessions per week. If you cannot complete 3 sessions per week the 36 sessions could be spread out over 6 months. Each session will last between 30-60 minutes. Sessions will involve aerobic activity, diet/nutritional counseling, and smoking cessation information. |
|
有源比较器：Control Group
Participants randomized to this group will receive care for their condition, conventional therapy, that they would normally receive.
|
Participants will be asked to complete tests and questionnaires that would normally be done for their condition.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in 6 minute walk test
大体时间：Change from Baseline to Up to 6 Months
|
Results will be measured in meters.
|
Change from Baseline to Up to 6 Months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Short Form Health Survey 36 (SF-36)
大体时间：Change from Baseline to Up to 6 Months
|
Change in quality of life measured using the SF-36.
The survey has 36 questions and measure eight health dimensions.
The scores range from 0-100.
A higher score represents less disability.
A lower score represents more disability.
|
Change from Baseline to Up to 6 Months
|
|
Short Form Health Survey 36 (SF-36)
大体时间：Change from Baseline to Week 18
|
Change in quality of life measured using the SF-36.
The survey has 36 questions and measure eight health dimensions.
The scores range from 0-100.
A higher score represents less disability.
A lower score represents more disability.
|
Change from Baseline to Week 18
|
|
Vascular Quality of Life Questionnaire-6 (VascuQol6)
大体时间：Change from Baseline to Up to 6 Months
|
The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings. Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status. |
Change from Baseline to Up to 6 Months
|
|
Vascular Quality of Life Questionnaire-6 (VascuQol6)
大体时间：Change from Baseline to Week 18
|
The six-item Vascular Quality of Life (VascuQol-6) is a valid, practical, and responsive instrument for the assessment of health-related QOL in patients with PAD. The main advantage is the compact format that offers a possibility for routine use in busy clinical settings. Range of scores and what they represent: Each question is scored 1-4. The total score is achieved by summarizing the score on each question, resulting in a score between 6 and 24. Higher value indicates better health status. |
Change from Baseline to Week 18
|
|
Absolute Claudication Distance (ACD)
大体时间：Change from Baseline to Up to 6 Months
|
ACD is defined as the walking distance after which a patient had to stop walking to relieve claudication pain.
Distance is measured in meters
|
Change from Baseline to Up to 6 Months
|
|
Functional Claudication Distance (FCD)
大体时间：Change from Baseline to Up to 6 Months
|
FCD is defined as the distance a patient would prefer to stop because of claudication pain.
Distance is measured in meters.
|
Change from Baseline to Up to 6 Months
|
合作者和调查者
调查人员
- 首席研究员：Kamal Gupta, MD、University of Kansas Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
外周动脉疾病的临床试验
-
University Hospital, Strasbourg, France尚未招聘
Cardiac Rehabilitation Program的临床试验
-
Universitair Ziekenhuis Brussel招聘中
-
Leiden University Medical CenterUMC Utrecht邀请报名
-
University of ManchesterNational Secretariat of Science, Technology and Innovation in Panama (SENACYT)完全的
-
University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
-
IRCCS Eugenio Medea招聘中