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临床试验/NCT00460668
NCT00460668已完成不适用

A Prospective Single Centre Open Randomized Trial on the Effect of Post-thoracotomy Pulmonary Rehabilitation on Quality of Life

Isala2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2007年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Isala
入组人数
57
试验地点
2
主要终点
SGRQ total score

研究概览

简要总结

The purpose of this study is to evaluate the effects of an integrated multidisciplinary rehabilitation program on health related quality of life in the 12 months postoperative period in patients with an elective thoracotomy and to evaluate the effects of the program on general quality of life (SF-36), acute/chronic post-thoracotomy pain, impairment (changes in pulmonary function), disability (exercise capacity) and start to complete recovery (ECOG score of 0 or 1) 12 months postoperatively in patients with an elective thoracotomy.

详细描述

Morbidity in the post operative phase of thoracotomies is characterised by pain, dyspnea, shoulder dysfunction and a loss of exercise tolerance may occur. There is literature about post-thoracotomy painsyndromes and postoperative quality of life has been investigated. However, data on post-thoracotomy rehabilitation and influence on morbidity and recovery are not available.

Aim of the study:

Primary: To evaluate the effects of an integrated multidisciplinary rehabilitation program on health related quality of life in the 12 months postoperative period in patients with an elective thoracotomy.

Secondary: To evaluate the effects of the program on general quality of life (SF-36), acute/chronic post-thoracotomy pain, impairment (changes in pulmonary function), disability (exercise capacity) and start to complete recovery (ECOG score of 0 or 1) 12 months postoperatively in patients with an elective thoracotomy.

Study design: prospective single-centre, open randomised trial. Eighty-eight elective thoracotomy patients with an age between the 18 and 80 years will be recruited during two years. The follow up for each patient will be one year. The exclusion criteria are chronic pain involvement, a previous thoracotomy, comorbidity limiting rehabilitation, psychiatric illness and non- compliance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective, thoracotomy patients with a surgical intention to cure.
  • age between 18 and 80 years.
  • ECOG 0 - 2 post-thoracotomy.

排除标准

  • patients with chronic pain.
  • a previous thoracotomy.
  • comorbidity limiting rehabilitation.
  • non-compliance

结局指标

主要结局

SGRQ total score

时间窗: 12 months

次要结局

  • SF-36 scores(12 months)
  • McGill pain questionnaire scores(12 months)
  • Pulmonary function and 6MWD(3 months)

研究者

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

Jan W.K. van den Berg

Dr.

Isala

研究点 (2)

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