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
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