An analysis of the feasibility and effectiveness of Home-Based Cardiac Rehabilitation using virtual Interactive Tele-Rehabilitation Platform ITRP CardiRehab in patients with coronary artery disease A Randomized control study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Completion of all scheduled rehabilitation sessions
研究概览
简要总结
Cardiac rehabilitation (CR) plays a crucial role in managing cardiovascular disease (CVD) in developed nations, but it has not yet gained widespread acceptance in India. In India, CR is significantly underutilized, with only one center available for every 360 cases of ischemic heart disease (IHD), resulting in a CR density of 360 (number of new IHD cases per year per CR spot). Consequently, India ranks among the lowest globally in terms of CR availability and access. The significant gap between the demand for and the availability of CR services suggests that a home-based CR model could address issues like accessibility, transportation costs, and time constraints. No randomized controlled trials have been conducted in India to compare the effectiveness of home-based CR with hospital-based CR. CR programs have been shown to improve functioning and quality of life as well as cardiovascular morbidity and mortality rates in adults with ischemic heart disease (IHD) following coronary interventions, heart failure, or cardiac surgery; however, participation in CR programs remains highly variable worldwide. These are significantly underused in India, with only a minority of eligible patients participating in CR. Novel delivery strategies and CR endorsement by healthcare organizations are urgently needed to improve participation rate. One potential strategy is home based CR (HBCR). Differing from conventional center based CR (CBCR) which are provided in medical supervised facility, HBCR relies on remote coaching with indirect exercise supervision. It is provided mostly or entirely outside of the traditional centre-based setting and could be facilitated by the aid of technology and web based applications. Cochrane collaborative reviews have compared Centre Based Cardiac Rehabilitation (CBCR) and HBCR and concluded that there is strong evidence that HBCR and CBCR have similar effects on quality of life and cost among patients with recent MI or coronary revascularization
We wish to study the efficacy of a home cardiac rehabilitation program via Interactive Tele-Rehabilitation Platform (ITRP) as compared to in- hospital cardiac rehabilitation (IHCR) in adult patients with coronary artery disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18-80 years, after obtaining a written informed consent from the participant.
- •Patients after an event of acute coronary syndrome (ACS) with or without revascularization (PCI).
- •Stable CAD with multiple conventional cardiovascular risk factors.
- •Diffuse CAD or partly revascularized CAD (complete revascularization was not feasible).
- •Patient with functional class NYHA II-NYHA III (stable) Patient willing to use Application and should be able to perform Home based Cardiac Rehabilitation.
排除标准
- •Presence of comorbid diseases or behavioural problems or any other limitations including dementia/cognitive issues which may interfere with performing unsupervised physical activity as per HBCR services protocol.
- •Decompensated heart failure (functional class NYHA IV).
- •Unstable angina.
- •Documented history of non-sustained VT, sustained VT or VF without any definitive treatment (anti- arrhythmic drugs, implantable cardiac- defibrillator, ablation), not rate controlled atrial arrhythmias, mobitz Type II- and third-degree AV blocks.
- •Documented history of recurrent syncope without definitive diagnosis and/ or presently undergoing evaluation.
- •Currently pregnant or intend to become pregnant in next year.
- •Heart Failure secondary to significant correctable reversible causes like primary valvular disease or correctable congenital heart disease.
- •Symptomatic valvular disease (advanced valvular heart disease stage American Heart Association class C-D).
- •Severe uncontrolled hypertension (SBP greater than 200 mm hg or DBP greater than 100 mm hg) not on medications (if blood pressures are controlled on mediation will be enrolled for the study).
结局指标
主要结局
Completion of all scheduled rehabilitation sessions
时间窗: Six months
次要结局
- Functional capacity (6MWT, treadmill test), quality of life (EQ-5D-5L,(MLHFQ), composite adverse clinical events, echocardiographic and biochemical parameters,)
研究者
Aditya John Binu
Christian Medical College, Vellore