A Randomized Controlled Trial to assess effectiveness of Home-based cardiac rehabilitation program on compliance and selected health outcomes among cardiac patients in selected hospitals of Punjab.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1.Proportion of patients with improved physical activity i.e. at least 30 minutes of moderate physical activity 5 days a week or more (minimum 150 minutes /week)
研究概览
简要总结
Introduction: Coronary artery disease (CAD) is a disease process that includes partial to complete occlusion of the vessel. Despite developments in treatment modalities, there is 9-fold increase in the incidence of CAD in the last twenty years in India. Cardiac rehabilitation as secondary prevention to cardiac events helps to reduce rehospitalization and assist patients with CAD to return to an active and satisfying life. Studies, unfortunately, revealed a higher attrition rate and underused CR services and a 10–30% lower rate among rural populations due to geographical location or health professional availability. It is hypothesized that Nurse-led-cardiac rehabilitation program is effective in improving health outcomes of cardiac patients as compared to conventional cardiac rehabilitation program.
Methodology: A randomized control trial is designed to evaluate the effectiveness of Nurse-led-cardiac rehabilitation program on selected health outcomes among cardiac patients after randomizing them to experimental and control group. All patients will start an exercise training in a supervised setting and then transition to a home-based regimen by giving them information booklets and CDs regarding exercises. The outcomes will be measured on the 3rd, 6th and 8th week of the program in terms of risk factors assessment parameters (Vital Parameters, BMI, Blood Chemistry, Lipids level, RFTs, LFTs), NYHA classification for assessment of Functional Status, 6 min walk test for evaluation of Exercise capacity, Quality of Life SF-36, Beck Anxiety inventory, Beck Depression Inventory.
Results: After reviewing literature, it was found that Nurse-led heart failure clinics are being practiced for years’ internationally but are not yet started in Punjab. Surely, there is a need to promote this hospital-home connection services led via cardiac nurse in preventing and managing CAD crisis.
Conclusion/Implication: The patients who were provided with comprehensive CR program by cardiac nurses improved signiï¬cantly in many terms. So, it was highly recommended in these studies to implement CR program led by a trained cardiac nurse for secondary prevention in patients with CHD.
Key Words: Nurse-led-cardiac rehabilitation program, health outcomes, cardiac patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •Those had undergone: 1.Cardiac events- myocardial infarction, coronary artery disease, stable angina, heart failure.
- •2.Interventions-Coronary Artery Bypass Grafting, Percutaneous Coronary Interventions, Valve Replacement, Pacemaker, Implanted Cardioverter Defibrillator.
- •3.Are in class-I and II according to New York Heart Association Functional Classification of Heart Failure.
排除标准
- •1.Those had Unstable angina pectoris,Acute endomyocarditis or other acute infections, Recent pulmonary artery embolism or phlebothrombosis, hemodynamically relevant arrhythmia, Critical obstructions of the left ventricular discharge apparatus
- •Those who have Physical, psychological or mental limitations prohibiting cardiac rehabilitation
- •Those who are in class-III and IV according to New York Heart Association Functional Classification of Heart Failure.
结局指标
主要结局
1.Proportion of patients with improved physical activity i.e. at least 30 minutes of moderate physical activity 5 days a week or more (minimum 150 minutes /week)
时间窗: 3 months
2.Proportion of patients with improved Diet i.e Saturated fats: 10% of total dietary energy per day, Fruits and vegetable: at least five portions of fruits and vegetable in a day or 400gms per day, Salt intake: less than 6gms of salt per day.
时间窗: 3 months
3.Medication Adherence
时间窗: 3 months
次要结局
- 1.6-Minute walk distance(2.BMI ( 25kg/m2))