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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 Coruña1 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1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
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
否

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.

研究组 & 干预措施

Rehabilitation Group

Experimental

The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program

干预措施: Pulmonary Rehabilitation Program (Behavioral)

Control Group

No Intervention

The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians.

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.

Exercise Tolerance

时间窗: Exercise tolerance 3 weeks after hospital discharge

Maximum time sustained (in seconds) during the constant-load cycle endurance test performed at 80% of the maximal workload achieved measured three weeks 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)
  • Health-Related Quality of Life(Quality of life 3 weeks after surgery)
  • Upper Body Strength(3 weeks post-surgery)
  • Lower Body Strength(3 weeks 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 (1)

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