Assessment of Frailty, Physical Capacity and Lung Function in Postoperative Cardiac Surgery Patients: an Observational and Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- To investigate changes in physical performance measured by Six-Minute Walk Test.
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, and respiratory and peripheral muscle strength in patients during the postoperative period following coronary artery bypass grafting (CABG) and valve replacement surgery..
详细描述
This study aims to investigate the physical changes in patients undergoing myocardial revascularization surgery and valve replacement. It will observe alterations in physical performance, lung function, and muscle strength during the postoperative period. The study, observational and prospective, will include individuals aged ≥18 scheduled for these surgeries, evaluating them preoperatively, post-intensive care unit discharge, and before hospital discharge. Assessments involve tests like the Short Physical Performance Battery, 1-minute sit-to-stand test, Clinical Frailty Scale, manovacuometry, dynamometry, and spirometry to identify frailty and measure muscle and lung function. The study also aims to explore predictive variables for functional loss and mortality 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 coronary artery bypass grafting surgery
- •Elective Heart valve surgery
- •Absence of cognitive or peripheral motor impairment that prevents the performance of functional tests in the preoperative period.
排除标准
- •Surgeries performed via lateral thoracotomy or minithoracotomy
- •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 physical performance measured by Six-Minute Walk Test.
时间窗: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
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 peripheral muscle strength
时间窗: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
Measure: hand grip strengh measure (Kgf)
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) and through study completion, an average of 15 days.
Measures: walking speed, standing balance and sit-to-stand performance.
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 after ICU discharge) and through study completion, an average of 15 days.
Measure: number of 1-MSTST repetitions.
To investigate changes in respiratory muscle strength:
时间窗: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
Measures: maximal inspiratory and expiratory pressure (cmH2O)
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 after ICU discharge) and through study completion, an average of 15 days.
Measures: FVC (L), FEV1 (L), FEF (L/s) and FEF 25-75 (%)
To investigate frailty by Clinical Frailty Scale (CFS)
时间窗: Baseline (one day before the surgery), after the surgery (the day immediately after ICU discharge) and through study completion, an average of 15 days.
The minimal value is 1 and the maximal is 9 in which the lowest scores mean worse outcomes.
次要结局
- To investigate hemodynamic behavior during the Short Physical Performance Battery (SPPB).(Immediately before and after the SPPB.)
- To investigate respiratory behavior during 1-minute sit-to-stand test (1-1-MSTST).(Immediately before and after the 1-MSTST tests.)
- 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 hemodynamic behavior during the 1-minute sit-to-stand test (1-MSTST).(Immediately before and after the 1-MSTST tests.)
- To investigate respiratory behavior during the Short Physical Performance Battery (SPPB).(Immediately before and after the SPPB.)
研究者
Rafael M. Ianotti, P.T., Ph.D.
Clinical Research Coordinator - Physiotherapy Division - Heart Institute (InCor)
University of Sao Paulo General Hospital