Technology-enabled Cardiac Rehabilitation Through PATHway. Feasibility, Clinical Effectiveness and Cost-effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Change in total volume of weekly active energy expenditure
研究概览
简要总结
The PATHway system is designed to help patients remain physically active and maintain a good cardiovascular health. It proposes a novel approach that aims to empower patients to self-manage their CVD, set within a collaborative care context with health professionals. This will be achieved via a patient-centric holistic approach that specifically addresses the above barriers. It involves an internet-enabled and sensor-based home exercise platform. It is represented by several modules with an exercise module as the core component which will provide individualized rehabilitation programs that use regular, socially inclusive exercise sessions as the basis upon which to provide a personalized, comprehensive lifestyle intervention program (managing exercise, smoking, diet, stress, alcohol use etc.) to enable patients to both better understand and deal with their own condition and to lead a healthier lifestyle in general.
The goal of this trial is to assess the acceptability, short-term effectiveness on lifestyle and health related physical fitness and cost-effectiveness of the PATHway intervention in patients with CVD in a single blind multicentre pilot randomised controlled trial (RCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with documented CVD
- •age 40-80 yrs
- •patients are on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 4 weeks
- •patients must have completed the ambulatory CR program and received clinical approval from their treating physician to continue exercising outside the hospital program
- •internet access at home
排除标准
- •significant illness during the last 6 weeks
- •known severe ventricular arrhythmia with functional or prognostic significance
- •significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing
- •cardiac disease that limits exercise tolerance (valve disease with significant hemodynamic consequences, hypertrophic cardiomyopathy etc.)
- •co-morbidity that may significantly influence one-year prognosis
- •functional or mental disability that may limit exercise
- •acute or chronic inflammatory diseases or malignancy, the use of anti-inflammatory drugs or immune suppression
- •GFR <25ml/min/1.73m2
- •hemoglobin < 10g/dl
- •severe chronic obstructive pulmonary disease (FEV1 < 50%)
- •NYHA class 4
- •participation in another clinical trial
研究组 & 干预措施
PATHway
Patients allocated to the PATHway intervention will be given a 4 week run-in period as an outpatient to get acquainted with the system. During this run-in period, the PATHway system will also be installed in each participant's home. They will be provided with a training manual and a quick set up guide for getting started with PATHway in the home.
After this 4 week run-in period, the PATHway system will be set up for each individual patient including a patient specific exercise prescription. The patient will then exercise with the PATHway platform for 6 months.
干预措施: PATHway (Behavioral)
Usual care
Patients randomized to the control group will receive usual care.
结局指标
主要结局
Change in total volume of weekly active energy expenditure
时间窗: 3 and 6 months
次要结局
未报告次要终点