To Evaluate Whether a Rehabilitation Protocol Improves Functional Status and Exercise Tolerance in Hospitalized Patients Awaiting Heart Transplantation While Receiving Positive Inotropic Support. Functional Tests and Scales Will be Used for Assessment. Patients Will Follow an 8-week Rehabilitation Program With Aerobic and Resistance Exercises Distributed Throughout the Week. A New Evaluation Will be Conducted at the End of the Intervention. Keywords: Heart Failure; Heart Transplantation; Physical Exercise
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- The study aims to compare pre- and post-intervention 6MWT in a single-arm design. Sample size estimates will test 20-30m differences, assuming 0.5 correlation, SD of 42.4, and 5% type I error for power calculations.
研究概览
简要总结
Heart failure is a condition where the heart cannot pump blood effectively. This can happen due to changes in the heart's structure or function, leading to symptoms like shortness of breath, fatigue, and reduced ability to exercise. These symptoms often worsen the patient's quality of life and increase hospital visits.
Exercise is known to help people with heart failure by improving blood flow to the muscles and increasing physical strength. Starting exercise early, even during hospitalization, may help prevent the negative effects of being inactive and improve recovery.
Some patients with advanced heart failure may need a heart transplant. While waiting for a transplant, these patients often receive intravenous medications to support heart function. However, they may become weaker and lose physical capacity during this time.
This study will test whether a supervised exercise program during hospitalization can help improve physical ability and exercise tolerance in patients with advanced heart failure who are on the heart transplant waiting list and receiving intravenous medication. The goal is to help these patients stay stronger and more stable while they wait for a transplant.
详细描述
Methods Type of Study This is a non-randomized clinical trial.
Sample Size The primary objective of the study is to compare the results of the 6-Minute Walk Test (6MWT) before and after the intervention, using a single-arm design. The null hypothesis assumes no difference between pre- and post-intervention. The alternative hypothesis will test for differences of 20, 25, or 30 meters to calculate potential sample sizes.
The analysis will consider the dependence between pre- and post-measurements, represented by a correlation coefficient of 0.5. The standard deviation will be based on the study by Forestieri (2016), which identified a value of 42.4. Assuming a Type I error rate of 5%, sample size estimates will be calculated according to the expected differences and statistical power, 22 patients
Data Collection Data for this study will be obtained through an assessment form that includes epidemiological data, functional tests such as the 6-Minute Walk Test (6MWT) and Sit-to-Stand Test (TSL1), and evaluations including manovacuometry, dynamometry, bioimpedance, and the DEMMI (De Morton Mobility Index). Measurements of quadriceps muscle thickness will be performed using ultrasound. Endothelial function will be assessed by measuring brachial artery dilation following a brief period of forearm ischemia, also evaluated via ultrasound.
Additional instruments include the Minnesota Living with Heart Failure Questionnaire to assess quality of life, the Feeling Scale to measure satisfaction during physical activity, and the Modified Borg Scale to assess perceived exertion. As an additional evaluation, a blood sample will be collected to assess oxidative stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •heart failure regardless ; using positive inotropic support regardless of the dose administered, medical prescription to undergo physical therapy.
排除标准
- •Patients under 18 years of age, atrial and ventricular arrhythmias that cause hemodynamic repercussions, patients with physical and/or cognitive limitations non-invasive ventilatory support to carry out the exercise.
研究组 & 干预措施
EFFECTS OF PHYSICAL TRAINING IN PATIENTS WITH ADVANCED HEART FAILURE
Endurance training
干预措施: physical training (Other)
结局指标
主要结局
The study aims to compare pre- and post-intervention 6MWT in a single-arm design. Sample size estimates will test 20-30m differences, assuming 0.5 correlation, SD of 42.4, and 5% type I error for power calculations.
时间窗: 2 days for evaluation, 8 weeks of rehabilitation protocol intervention, and 2 days for re-evaluation
The main objective of the study is to compare the six-minute walk test (6MWT) post-intervention with pre-intervention, using a one-arm intervention. The null hypothesis is that there are no differences between pre- and post-intervention. The alternative hypothesis will test differences of 20, 25, or 30 meters for possible sample size calculations. The dependence of pre- and post-measurements will be considered, represented by a correlation of 0.5. The standard deviation, which identified a value of 42.4. Considering a 5% type I error, we estimate possible sample sizes according to pre- and post-differences and the power of the test:
次要结局
未报告次要终点
研究者
LUCIANA MARIA MALOSA SAMPAIO
Pofessor Doctor
University of Nove de Julho