NCT01693172Unknown不适用
Effect of an Early Mobilization Program After Surgery on Functional Recovery and Clinical Complications in Patients Undergoing Major Cancer Surgey : a Randomized Controlled Trial
Instituto do Cancer do Estado de São Paulo2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2014年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Ability to walk three meters or crossing a room without assistence
研究概览
简要总结
The aim of this study is to evaluate the effect of an early postoperative physical rehabilitation program on the functional capacity and incidence of postoperative complications in patients undergoing major elective surgery for treatment of a neoplasm
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Patients who will be submitted to major surgery for cancer treatment.
- •Age ≥ 18 years
- •Reading and signing the informed consent
排除标准
- •Acute myocardial infarction (within the last 30 days)
- •Unstable Angina
- •Cardiac arrhythmia uncontrolled
- •symptomatic severe aortic stenosis
- •Congestive heart failure NYHA III or IV
- •infarction or acute pulmonary thromboembolism
- •pericarditis or myocarditis
- •Acute Endocarditis
- •Acute aortic dissection
- •Active infection
- •Acute renal failure
- •Thyrotoxicosis
- •Refusal to participate in the study
- •Inability to ambulate independently and / or inability to exercises
- •Presence of bone metastasis
- •musculoskeletal and neurological conditions that preclude the achievement of an exercise program designed for this study
研究组 & 干预措施
early postoperative mobilization
Active Comparator
Early postoperative supervised aerobic exercise, resistance and flexibility training
干预措施: Early mobilization program (Behavioral)
Standard
No Intervention
Standard rehabilitation care
结局指标
主要结局
Ability to walk three meters or crossing a room without assistence
时间窗: at 5 days after surgery or at hospital discharge
次要结局
- hospital costs(at 180 days after surgery)
- fatigue(at 5 and 30 days after surgery)
- quality of life(at 5, 30, 180 and 365 days after surgery)
- length of hospital stay(at hospital discharge)
- recurrence of cancer(at 180 days after surgery)
- post operatorative complications(at 30 days after surgery)
研究者
Elisangela P M de Almeida, MD
Principal Investigator
Instituto do Cancer do Estado de São Paulo
研究点 (2)
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