Evaluation of Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients: an Observational and Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To investigate changes in peripheral muscle strength.
研究概览
简要总结
The goal of this observational and prospective study is to investigate changes in physical performance, lung function, respiratory and peripheral muscle strength in patients during the postoperative period following pulmonary endarterectomy (PET).
详细描述
This study aims to investigate the physical changes in patients undergoing pulmonary endarterectomy (PET). It will observe alterations in physical performance, lung function, and muscle strength during the postoperative period. This study, observational and prospective, will include individuals aged ≥18 scheduled, evaluating them preoperatively, post-intensive care unit discharge, before hospital discharge and after six months . Assessments involve tests like the Six-minute walk test, Short Physical Performance Battery, One-minute sit-to-stand test, manovacuometry, dynamometry, spirometry and Clinical Frailty Scale to identify frailty and measure muscle and lung function. The study also aims to explore predictive variables for functional loss during hospitalization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •Both genders
- •Elective pulmonary endarterectomy surgery
- •Absence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the preoperative period.
排除标准
- •Reoperation for any reason
- •Presence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the postoperative period.
结局指标
主要结局
To investigate changes in peripheral muscle strength.
时间窗: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
Measure: hand grip strengh (Kgf).
To investigate changes in respiratory muscle strength:
时间窗: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
Measures: manovacuometry (cmH2O)
To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB).
时间窗: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after surgery.
Measure: global score
To investigate changes in physical performance by 1-minute sit-to-stand test (1-MSTST).
时间窗: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
Measure: number of 1-MSTST repetitions.
To investigate changes in physical performance measured by Six-Minute Walk Test.
时间窗: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery.
Measures: the assessment will take place in a flat 30-meter corridor, marked every 1 meter with non-slip flooring, and the patient will be instructed to walk for six minutes as fast as possible.
To investigate changes in lung function test measure by spirometry:
时间窗: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
To investigate frailty by Clinical Frailty Scale (CFS)
时间窗: Baseline (one day before the surgery), after the surgery (the day immediately ICU discharge), before the hospital discharge (an average of 20 days) and 6 months after the surgery
The minimal value is 1 and the maximal is 9 in which the lowest scores mean worse outcomes.
次要结局
- To explore potential preoperative and immediate postoperative risk factors as predictors of functional loss.(Baseline (one day before the surgery) during the immediate postoperative period.)
- To investigate changes in hemodynamic and respiratory variables during the funcional tests.(Immediateley before and after each functional test.)
研究者
Rafael M. Ianotti, P.T., Ph.D.
Clinical Research Coordinator - Physiotherapy Division - Heart Institute (InCor)
University of Sao Paulo General Hospital