EXercise InTervention in Heart Failure (EXIT-HF): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Peak oxygen uptake (ml/kg/min)
研究概览
简要总结
This is a pragmatic, non-inferiority clinical trial, enrolling heart failure patients who will be randomized to a 12-week exercise training program either centre-based or home-based with telemonitoring. The impact of this intervention will be assessed on established surrogate markers in HF such as maximal exercise capacity, plasma biomarkers and quality of life. The cost-effectiveness and overall satisfaction with the treatment will also be studied. In addition to measure the clinical and economic impact of this innovative way of delivering exercise, it is intended to unravel new molecular pathways and assess a pool of biomarkers that provide a wide mechanistic picture underlying the clinical effects of exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of HFrEF and HFpEF according to criteria of the European Society of Cardiology (2016)
- •Clinical stability for ≥ 6 weeks
- •Optimal medical treatment for ≥ 6 weeks
- •Patients that are able to understand and follow the exercise prescription
- •Written informed consent
排除标准
- •Patients who have undertaken cardiac rehabilitation within the past 12 months
- •Patients who have received an intracardiac defibrillator (ICD), Cardiac
- •Resynchronisation therapy (CRT) or combined CRT/ICD device implanted in the last 6 weeks
- •Inability to exercise or conditions that may interfere with exercise intervention
- •Signs of ischemia during cardiopulmonary exercise test
- •Comorbidity that may influence one-year prognosis
- •Symptomatic and/or exercise induced cardiac arrhythmia or conduction disturbances
- •Currently pregnant or intend to become pregnant in the next year
- •Expectation of receiving a cardiac transplant in the next 6 months
- •Participation in another clinical trial
- •Patients who are unable to understand the study information or unable to complete the outcome questionnaires
结局指标
主要结局
Peak oxygen uptake (ml/kg/min)
时间窗: Change from baseline in peak oxygen uptake (ml/kg/min) at 3 months
Patients will be submitted to cardiopulmonary treadmill exercise tests at baseline and after 3 moths
次要结局
- Disutility(Evaluate at 3th month)
- 6-min walk test (6MWT) distance(Change from baseline to 3 months, and to 12 months.)
- Health status (EQ-5D-5L)(Change from baseline to 3 months, and to 12 months.)
- Hand grip strength(Change from baseline to to 3 and to 12 months.)
- Health-related quality of life (MLHFQ)(Change from baseline to 3 months, and to 12 months.)
- Anxiety and Depression (HADS)(Change from baseline to 3 months, and to 12 months.)
- Physical activity (steps/day)(Change from baseline to 3 months, and to 12 months.)
- Daily physical activity levels (min/day)(Change from baseline to 3 months, and to 12 months.)
- Dyspnea(Change from baseline to 3 months, and to 12 months.)
- Percentage of protein aggregates(Change from baseline to 3 months)
- Physical fitness levels evaluation(Change from baseline to 3 and to 12 months.)
- Mediterranean diet(Change from baseline to 3 months, and to 12 months.)
- Concentration of plasma exosomes(Change from baseline to 3 months)
- Circulating number of endothelial progenitor cells, circulating endothelial cells, nitric oxide and endothelial Nitric Oxide Synthase(Change from baseline to 3 months)
- Biomarkers (mg/L)(Change from baseline to 3 months)
- Biomarkers (pg/ml)(Change from baseline to 3 months)
- Cost-effectiveness of home-based exercise Vs. clinical-base exercise(At 12th month)
研究者
Mário André Silva Santos
Cardiologist, MD, PhD
Centro Hospitalar do Porto