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临床试验/NCT04568564
NCT04568564已完成不适用

Telerehabilitation of Reduced Physiotherapy Service in SARS-CoV-2 Pandemic Process in Lung Surgery Patients

Istanbul Medipol University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年10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
入组人数
40
试验地点
2
主要终点
Major complication rate

研究概览

简要总结

In this study, providing access to physiotherapy applications by telerehabilitation method and the effectiveness of this application will be examined for patients who have undergone lung surgery in the early postoperative period during the pandemic process in which social isolation continues.

详细描述

  • Patients who meet the inclusion criteria and agree to participate in the study will be included in the study.
  • Patients diagnosed with lung cancer and underwent thoracotomy will be randomly divided into Telerehabilitation Group (TGR) and Control (KG) groups.
  • Before the operation, enlightened and signed consent will be obtained from the cases, the first evaluations of the patients in both groups will be made and the first exercise training will be given to the telerehabilitation group.
  • The study group will be followed up every day during their hospitalizations and the final tests of both groups will be made before discharge. Long-term follow-up will be carried out in the 1st month and 3rd month after discharge.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having a smart phone and capable of making video calls,
  • Planned to be operated with thoracotomy or videothoracoscope,
  • Staged between IA and IIIB with clinical staging,
  • With proven lung tumor (If AC diagnosis is not confirmed after frozen or wedge, the patient will be excluded from the study),
  • Patients with no cardiac disease (ASA II or better) that affects their quality of life.

排除标准

  • Having a cardiac disease that affects the quality of life,
  • Serious cognitive problems and presence of psychiatric diseases,
  • Presence of physical limitations (vision, hearing impairment, orthopedic problems).

结局指标

主要结局

Major complication rate

时间窗: Up to 3 months

Major complication rates such as postoperative fever, infection, and hemorrhage will be documented.

次要结局

  • Visual analog scale(Up to 3 months)
  • Diffusion Capacity(Change from baseline to 1 and 3 months)
  • Lung V/Q Scintigraphy(Change from baseline to 1 and 3 months)
  • Procalcitonin (PCT)(Up to 3 months)
  • C-Reactive Protein (CRP)(Up to 3 months)
  • Ferritin(Up to 3 months)
  • D'dimer test(Up to 3 months)
  • Partial Oxigen Pressure (PaO2)(Up to 3 months)
  • The six-minute walking test(Up to 3 months)
  • Duration of tube thoracostomy drainage(Up to 3 months)
  • Forced expiratory volume one second (FEV1)(Up to 3 months)
  • Modified Medical Research Council Dyspnea Scale(Up to 3 months)
  • Forced vital capacity (FVC)(Up to 3 months)
  • Lung Capacities(Change from baseline to 1 and 3 months)
  • Lactate dehydrogenase(Up to 3 months)
  • Partial Carbon monoxide Pressure (PaCO2)(Up to 3 months)
  • Arterial blood oxygen saturation level (SaO2)(Up to 3 months)
  • Anxiety inventory(Up to 3 months)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

esra pehlivan

Principal investigator

Saglik Bilimleri Universitesi

研究点 (2)

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