Nursing Rehabilitation on Patients Admitted by Recently Decompensated Heart Failure (ERIC Program) - Impact of Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- 6 minute walking test
研究概览
简要总结
An aerobic physical exercise protocol will be applied to patients admitted in ward due to decompensated heart failure, in order to validate the efficacy and safety of physical exercise in this phase of clinical stabilization, through the said training protocol - ERIC program.
详细描述
With the objective of validating the efficacy and safety of physical exercise as a therapeutic resource in patients admitted for decompensated heart failure; will be applied, by rehabilitation nurses, a protocol of physical exercise, with increasing levels of intensity. Patients who meet the inclusion criteria will be randomized through an online program (randomizer.org) and the ERIC protocol will be applied to the test group. The control group will be implemented the usual care of rehabilitation nursing. The ERIC protocol comprises 5 levels of intensity, as following shown:
Stage 1 - respiratory and calisthenic exercises (5-10 minutes) Stage 2 - pedaler for 5-10 minutes Stage 3 - aerobic training: walking on the corridor for 5-10 minutes Stage 4 - aerobic training: walking on the corridor for 10-15 minutes Stage 5 - aerobic training: walking on the corridor for 15 minutes + climbing stairs for 5 minutes
All patients will be monitored and followed up by a rehabilitation nurse while they are doing the exercise. The investigator decides, depending on the patient's performance and clinical conditions, the form of progression in the program, but it is mandatory to follow the previously defined levels of intensity. Patients in the test group may start the program only on stage I or II according to clinical criteria.
At admission of the patients (test group and control group) clinical and sociodemographic parameters are evaluated, as well as data related to Barthel's indices and London Chest of activities of daily living (LCADL). At the discharge date, the Barthel index and the LCADL scale will also be evaluated, as well as the 6-minute walking test.
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
- Double (Participant, Investigator)
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
- •Admission diagnosis of Decompensated heart failure
- •More than 18 years old
- •Capacity to provide informed consent
排除标准
- •Osteoarticular pathology that impedes the performance of the exercise;
- •Existence of inotropic infusions;
- •Dysrhythmia or precordial pain in the last 24 hours,
- •Acute pulmonary edema in the last 12 hours,
- •SBP greater than 180mmHg or less than 80 mmHg (except in cases where this is the baseline value for the patient),
- •Need for oxygen at a rate greater than 3 l / min,
- •Glycemic decompensation in the last 12 hours,
结局指标
主要结局
6 minute walking test
时间窗: Through study completion, an average of 1 year
Number of meters walked in the 6 minute walking test
次要结局
- Cardiac adverse events(Through study completion, an average of 1 year)
- London Chest Activity of Daily Living scale score(Through study completion, an average of 1 year)
- Barthel Index score(Through study completion, an average of 1 yeare)
研究者
Bruno Miguel Delgado
Nurse
Centro Hospitalar do Porto