Is Non-invasive Ventilation Effective in Improving the Exercise Capacity in Patients With Cardiac Heart Failure?: 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
- 12
- 试验地点
- 2
- 主要终点
- Change from baseline in exercise tolerance
研究概览
简要总结
Patients with heart failure (HF) have a reduced exercise tolerance as the main result of the disease. This exercise intolerance is due to heart conditions, but also to dysfunction of the respiratory and peripheral muscles. Various factors such as chronic hypoxia, oxidative stress, nutritional depletion, peripheral muscle disuse, effects of medications, and sympathetic-vagal imbalance are major contributors to deconditioning. In this scenario, the use of non-invasive ventilatory support (NIV) arises as an adjunct to cardiac rehabilitation in the attempt to improve the functional capacity of patients, since NIV reduces work of breathing, improves oxygenation and increases lung compliance associated with improved ejection volume, due to increased intrathoracic pressure.
详细描述
The main objective is to evaluate whether the use of NIV during Constant Treadmill Load Tests (CTLT) enhances exercise performance in Cardiac Heart Failure (CHF) patients on a treadmill.
Each recruited patient will be evaluated on 4 occasions, with two different evaluations, an incremental test (IT) to find out the maximum aerobic speed reached and then, in randomized order, three CTLT at 85% of the maximum reached in the IT . Two of the three CTLT will be performed with the use of NIV, with PS (IPAP 10cmH2O and EPAP 5cmH2O) and CPAP (5cmH2O) mode, and the rest will be without the use of NIV. The main study variable will be the time tolerated on the treadmill during CTLT.
Participants will have 5 minutes to adapt to NIV, 5-minute warm-up at 50% and then will start with the CTLT at 85% of the maximum aerobic speed reached in the IT.
In total, each patient will be evaluated four times on four different visits.
Sample size: For the sample's calculation, the maximum time in CTLC was chosen as the main study variable because it is a sensitive measure to detect changes after interventions (both pharmacological and non-pharmacological) and widely used in clinical trials. A minimum difference to detect of 100 seconds from previous literature was determined. Taking this data into account, and using a level of α of 0.05, a 1-β power of 0.80, and an effect size of 0.8, the sample size calculation for a paired t-test investigators found that at least 12 participants are needed. The calculation was made using the Gpower 3.1.9.7 software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ejection fraction demonstrated by echocardiography ≤ 40% (in the last 12 months).
- •NYHA functional class I - III.
- •Clinical stability, defined as four weeks prior to the start of the study without hospitalizations.
- •Signed informed consent.
- •≥ 18 years of age.
排除标准
- •Chronic obstructive pulmonary disease (COPD), unstable angina or significant arrhythmias.
- •Myocardial infarction in the last 3 months, primary valve disease and anemia (hemoglobin under 13 g/dl for men or 12 g/dl for women).
- •Patients who are smokers or ex-smokers of less than one year.
- •Patients with cognitive impairment that prevents the correct understanding of the evaluations.
- •Any neuromuscular or osteoarticular condition that limits test performance.
- •Refusal to participate.
结局指标
主要结局
Change from baseline in exercise tolerance
时间窗: At the end of exercise
Change in Maximun Walking time tolerated in a Constant Treadmill Load Test (CTLT) in seconds on treadmill between PS, CPAP and WNIT
次要结局
- Change in Dyspnea(At the end of exercise)
- Change in Cardiac Rate(At the end of exercise)
- Change in Oxygen Saturation(At the end of exercise)
- Change in Global Comfort(At the end of exercise)
- Change in Lower Limbs Fatigue(At the end of exercise)
- Change in Blood Pressure(At the end of exercise)
- Change in Recovery heart rate(At the end of exercise)
- Change in the motive for stopping the test(At the end of exercise)
研究者
Guillermo A. Mazzucco
Principal Investigator
University of Gran Rosario