NCT05708313已完成不适用
Effects of 9-18 Weeks of Intensive Cardiac Rehabilitation After a Major Cardiovascular Event in Patients With Cardiovascular Disease-AHH-ICR
Arkansas Heart Hospital2 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2019年9月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Serum Lipid
研究概览
简要总结
Implement an intensive cardiac rehabilitation program at Arkansas Heart Hospital (AHH) to find out if the AHH-ICR is equivalent to the CMS approved programs when it comes to results.
详细描述
Implement the ICR Program to determine if
- AHH-ICR will increase patients physical and psychological well-being and is non-superior/comparable to current ICR programs.
- To determine the most appropriate ICR program protocols to improve fitness and decrease cardiovascular risk factors.
- To determine if the ICR program has a direct relationship to improvements in the health of cardiovascular patients.
- To determine non-inferiority to already established ICR programs in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for cardiac rehab per CMS requirements.
- •Males and Females Age ≥ 65≤ 85 years
- •Acute myocardial infarction within the preceding 6 months
- •Coronary artery bypass surgery
- •Current stable angina pectoris (chest pain)
- •Heart valve repair or replacement
- •Percutaneous transluminal coronary angioplasty or coronary stenting
- •BMI ≥ 18 ≤35
排除标准
- •Renal or hepatic dysfunction
- •Amputees (unless both groups have similar patients)
- •Current chemo/radiation treatment (unless both groups have similar patients)
- •Malnutrition
- •Post-Bariatric surgery patients
- •History of substance abuse
- •Gastroparesis
- •Patients taking Warfarin/Coumadin
- •CHF patients on fluid restrictions requiring monitoring of water intake from food and liquids.
- •Cognitive deficits that would preclude cardiac rehabilitation
- •Patients with physical limitations that would prevent cardiac rehabilitation
- •Patients who are unable to attend the program
- •Patient who live >45... miles from cardiac rehab center
结局指标
主要结局
Serum Lipid
时间窗: Baseline to program completion (9-18 weeks)
Total cholesterol, ADH, LDL and triglycerides (mg/dl)
Body Mass Index
时间窗: Baseline to program completion (9-18 weeks)
calculated from Height and weight.
Hemoglobin A1c
时间窗: Baseline to program completion (9-18 weeks)
measure in whole blood (normal 4.5-6.2 (%))
Resting Blood Pressure
时间窗: Baseline to program completion (9-18 weeks)
Systolic and Diastolic Blood Pressure (mmHg)
次要结局
- 6-minute walk test(Baseline and at program completion (9-18 weeks))
- Perceived Exertion (RPE)(Baseline to program completion (9-18 weeks))
- Hospital Re-admission rate(Baseline to program completion (9-18 weeks))
- Patient Health Questionnaire (PHQ9)(Baseline to program completion (9-18 weeks))
- Diet intake(Baseline to program completion (9-18 weeks))
- Duke Activity Index(Baseline to program completion (9-18 weeks))
- Dartmouth Coop quality of Life Questionnaire(Baseline to program completion (9-18 weeks))
- Resting Metabolic Rate(Baseline to program completion (9-18 weeks))
- Medication Changes(Baseline to program completion (9-18 weeks))
研究者
研究点 (2)
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