跳至主要内容
临床试验/NCT01963923
NCT01963923已完成不适用

Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Exercise Tolerance and Quality of Life in Patients Awaiting Lung Resection by Video-assisted Thoracic Surgery

Universidade da Coruña2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Exercise Tolerance

研究概览

简要总结

The purpose of this study is to establish the effectiveness of a preoperative pulmonary rehabilitation program in patients awaiting lung resection for lung cancer by Video-assisted thoracic surgery in order to improve exercise tolerance and quality of life. The investigators hypothesized that a pulmonary rehabilitation program including both endurance and strength training may improve exercise tolerance and quality of life measured with a submaximal exercise test and a quality of life questionnaire respectively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Diagnosis confirmed or suspected of lung cancer (either primary or metastatic)
  • Be on the waiting list for lung resection by Video-assisted thoracic surgery
  • Present at least one of the next conditions: Forced Expiratory Volume in 1 second (FEV1)<80% of predicted and/or Body Mass Index > 30 or/and >80 years old and/or two or more comorbidities (Arterial Hypertension, Chronic Obstructive Pulmonary Disease, Coronary Disease, Diabetes, Renal Failure and/or cancer.
  • No smoking at the time of recruitment
  • Signed Informed Consent

排除标准

  • Chemotherapy or Radiotherapy in the previous 6 months before the Rehabilitation program.
  • Thoracotomies or pneumonectomies.

结局指标

主要结局

Exercise Tolerance

时间窗: Exercise tolerance 3 months after surgery

Maximum time sustained (in seconds) during the constant-load cycle endurance test performed at 80% of the maximal workload achieved measured three months after hospital discharge in comparison with the control group.

次要结局

  • Lower Body Strength(3 months post-surgery)
  • Upper Body Strength(3 months post-surgery)
  • Health-Related Quality of Life(Quality of life post-surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esther Gimenez Moolhuyzen

Physiotherapist

Hospital Juan Canalejo

研究点 (2)

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