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临床试验/NCT05136300
NCT05136300Unknown不适用

Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer

Isala1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
Isala
入组人数
100
试验地点
1
主要终点
Quality of life (SF-36)

研究概览

简要总结

Morbidity in the post-operative phase of pulmonary surgery is characterised by impairment due to pain, dyspnoea and loss of exercise tolerance. We demonstrated previously that rehabilitation after thoracotomy is limited due to pain. Since minimal invasive surgery is the new standard in lung cancer, resulting in a reduction of postoperative pain, we believe there are new possibilities for post-operative integrated multidisciplinary rehabilitation in lung cancer.

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
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

  • Patients undergoing elective, minimal invasive surgery with intention to cure.
  • Age between 18 and 80 years.
  • ECOG 0 - 2 post-surgery.

排除标准

  • Patients with chronic pain
  • Previous pulmonary surgery
  • Comorbidity limiting rehabilitation
  • Rheumatoid arthritis
  • Severe ischaemic heart disease or myocardial failure; EF ≤ 35 %.
  • Muscle disease
  • Fibromyalgia
  • Neurologic disorders (Parkinson disease, CVA and lesions of the spinal cord)
  • Psychiatric disorders

结局指标

主要结局

Quality of life (SF-36)

时间窗: 12 months

effects of an integrated multidisciplinary rehabilitation program on general quality of life

次要结局

  • VAS(12 months)
  • international physical activity questionnaire, iPAQ(12 months)
  • SGRQ(12 months)
  • WHO-PS(12 months)
  • 6 minute walking distance(12 months)

研究者

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

Lars Dinjens

MD

Isala

研究点 (1)

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