Physical Rehabilitation in Patients With Complex Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluate the response to aerobic activity and peripheral muscle strength training in children with congenital heart disease.
研究概览
简要总结
Studies have shown that patients with congenital heart disease have functional changes compared to healthy individuals. Several interventions can be performed to minimize these changes; physical rehabilitation is one of these possible treatments that can generate numerous benefits for patients. The aim of this study is to evaluate the response to physical rehabilitation in patients after surgical correction of congenital heart disease.
Methods This cross-sectional study included patients with complex congenital heart disease who underwent surgical correction. Different examinations were performed: cardiopulmonary exercise was used; and the six-minute walk test was used to determine functional capacity, the quality of life cardiac version questionnaire was used to determine quality of life. Descriptive analysis of patients was performed for all the data.
详细描述
Study design and population This cross-sectional study analyzed those patients with complex congenital heart disease who underwent surgical correction at Hospital do Coração, São Paulo - Brazil. The institutional ethics committees on human research approved . All the subjects signed consent forms before starting the protocol.
The survey of patients eligible for the physical rehabilitation protocol was conducted at the Congenital Cardiology Outpatient Clinic of the Hospital do Coração. Patients currently under clinical follow-up the investigators selected for inclusion in the study. The protocol was presented to the medical team, and patients who did not exhibit neuromuscular, pulmonary, or complex orthopedic conditions that could interfere with the performance of the assessments the investigators chosen.
Transthoracic echocardiography The transthoracic echocardiographic evaluation will be performed using the two-dimensional technique, always by an echocardiographer. All images will be obtained by software, using an appropriate transducer. Echocardiographic measurements will be made in accordance with the recommendations of the congenital heart disease consensus.
Cardiopulmonary exercise test The cardiopulmonary exercise test was performed using a treadmill exercise test equipped with a metabolic analyzer. This assessment aimed to determine the subject's maximal cardiopulmonary capacity.
Blood pressure measurements were taken at rest, every two minutes during exercise, and every minute during the recovery phase. All readings were taken by the same observer, using the auscultatory method to ensure consistency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •no previous or current history of other non-cardiological disease
- •patients undergoing complex congenital heart surgeries with a minimum postoperative period of 1 year
- •clinically stable; with no complex arrhythmia(s) in the last electrocardiogram or clinical evaluation
- •with medical monitoring
- •clinical clearance to carry out the protocols
- •consent with the Free and Informed Consent Form (FICF) and Assent Form signed by the guardian and the patient respectively.
排除标准
- •patients with musculoskeletal or neuropsychiatric alterations without the possibility of performing a functional test (ergospirometry test),
- •hemodynamically unstable patients
- •severe respiratory or metabolic conditions
- •patients residing in regions far from São Paulo,
- •patients which make frequent visits to the institution unfeasible
- •patients who do not attend the rehabilitation program or those for whom it was not possible to maintain and update registration data.
结局指标
主要结局
Evaluate the response to aerobic activity and peripheral muscle strength training in children with congenital heart disease.
时间窗: In 36 physical rehabilitation sessions, twice a week lasting about 4.5 weeks
Quantify the speed (which is the measurement of distance in kilometers divided by time in hours) of walking and running in km/h during aerobic exercises on a treadmill; evaluate the load capacity in kilograms in lower and upper limb exercises.
次要结局
- Quality of life assessment(The test lasts approximately 10 minutes and will be performed on day 1 of care and on the last day - day 36.)
- The cardiopulmonary test - ergospirometry(The test lasts approximately 30 minutes and will be performed on the first day - day 1 of care and on the last day - day 36 of care for discharge.)
- Submaximal exercise test - six-minute walk test(The test lasts approximately 10 minutes and will be performed on day 1 of care and on the last day - day 36.)
- Assessment of cardiac function(The test lasts approximately 30 minutes and will be performed on the first day - day 1 of care and on the last day - day 36 of care for discharge.)