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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00026985
Enrollment
391
Registered
2021-12-21
Start date
2022-03-17
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients planned to undergo one of the following surgeries as the leading and initial OPS-code are eligible to participate in the PATRONUS prehab app program in case of missing contra-indications and exclusions.OPS codes in accordance with the 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 (

Interventions

Group 1: The Patronus Prehab App is a software solution that provides a risk-based endurance aerobic interval exercising program for adult patients before major surgical procedures to improve their ae

Sponsors

Goethe-Universität Frankfurt
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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) and 10 healthy volunteering students (no planned surgery) and 15 asymptomatic patients with a history of myocardial infarction (no planned surgery) and 15 patients with a COPD lower than GOLD grade III (no planned surgery)

Exclusion criteria

Exclusion criteria: -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)

Design outcomes

Primary

MeasureTime frame
Define - App-based risk score, Clavien-Dindo-Score - Ratings based on uMARS (Mobile Application Rating Scale), and elements of the ABACUS and the Trustworthiness Checklist, and the App-checklist of the Aktionsbündnis Patientensicherheit e. V.

Secondary

MeasureTime frame
Pulse, distance, step-measurement Safety data, especially focusing on cardiovascular and pulmonary events within the exercising program defined with the Karvonen Method Precision of the risk-based approach Alarming and safety scenarios within the intended use

Countries

Germany

Contacts

Public ContactFatima Faqar-Uz-Zaman

Frankfurt University Hospital Goethe-University Frankfurt/Main Department for General, Visceral and Transplant Surgery

SaraFatima.Faqar-Uz-Zaman@kgu.de+49-69-6301-87197

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 9, 2026