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临床试验/DRKS00026985
DRKS00026985已完成未知

A pilot trial to analyze the usability, validity and safety of an interventional health app program (Patronus prehab app) for the structured prehabilitation of patients before major surgical interventions: PROTEGO MAXIMA - PROTEGO MAXIMA

Goethe-Universität Frankfurt0 个研究点目标入组 391 人开始时间: 2021年12月21日最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
391

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
N/a: Single Arm Study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • Written informed consent
  • Willing to participate in the particular task I, II, IIIa and IIIb the respective participant has been asked for
  • Able to understand the survey and scenarios
  • Patients planned to undergo one of the following surgeries [OPS codes in accordance with the DIMDI OPS version 2021]:
  • 5-070 to 5-073, 5-077 to 5-079 (endocrine glands)
  • 5-32 to 5-43 (lung and bronchus)
  • 5-38 to 5-39 (vascular surgeries without cardiovascular surgery)
  • 5-413 and 5-419 (splenectomy)
  • 5-423 to 5-427 (esophagectomy)
  • 5-434 to 5-438 (gastrectomy)
  • 5-44 (non resecting gastric bypass operations)
  • 5-454 (small bowel resections)
  • 5-455 (large bowel resections)
  • 5-456 (proctocolectomy)
  • 5-484 and 5-485 (rectum resections)
  • 5-502 and 5-503 (anatomical liver resection)
  • 5-512, 5-514.30, 5-515, 5-518.4 and .5 (biliary tract resections)
  • 5-523, 5-524, 5-525, 5-527 and 5-529 (pancreas resections and draining procedures)
  • 5-536 (abdominal wall hernias)
  • 5-553, 5-554, 5-575 to 5-579, 5-604 (urologic resections: kidney, bladder, prostate)
  • 5-652, 5-653, 5-661, 5-683 to 5-687 (gynecologic resections of uterus, ovary, cervix)
  • 5-87 and 5-88 (breast surgery)
  • 10 healthy volunteering students (no planned surgery)
  • 15 asymptomatic patients with a history of myocardial infarction (no planned surgery)
  • 15 patients with a COPD lower than GOLD grade III (no planned surgery)

排除标准

  • -Currently pregnant
  • -Unable to understand the rationale and the aims of the proposed training program
  • -Unable to interact with the application
  • -Patients with an ECOG performance status of 4.
  • -Patients unable to walk, run, step, or cycle.
  • -Acute myocardial infarction or unstable angina (acute phase) (I20.0, I21)
  • -Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
  • -Acute myocarditis or pericarditis (I30, I39, I40)
  • -Uncontrolled acutely decompensated HF (acute pulmonary edema) (J81)

研究者

发起方
Goethe-Universität Frankfurt

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