A multicenter prospective randomized controlled trial to test the safety and efficacy of a systematic app-based remote and home-based prehabilitation program in comparison to education only before major surgeries: The LUMOS Study.
- Registration Number
- DRKS00033612
- Lead Sponsor
- Goethe Universität Frankfurt am Main, Universitätsklinikum Frankfurt
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 382
Written informed consent
- Willing to participate
- Patients have an Android or iOS-based smartphone
- Patients who are planned for one of the following surgeries as the leading and initial OPS-code are eligible to participate in the LUMOS trial in case of missing contra-indications and exclusions. OPS codes in accordance with the DIMDI OPS version 2024: https://klassifikationen.bfarm.de/ops/kode-suche/htmlops2024/index.htm:
5-070 to 5-073, 5-077 to 5-079 (endocrine glands)
5-314, 5-316, 5-32 to 5.334, 5-339 to 5-349 (trachea, lung and bronchus)
5-38 to 5-39 (vascular surgeries without cardiovascular surgery)
5-404.1 to 5-405, 5-406.2 to 5-406.9+a+b, 5-407 (lymphadenectomies)
5-413 and 5-419 (splenectomy)
5-423 to 5-427 (esophagectomy)
5-434 to 5-438 (gastrectomy)
5-445 and 5-446 (non resecting gastric bypass operations)
5-454 (small bowel resections)
5-455 and 4-466 (large bowel resections including Hartmann’s revision)
5-456 (proctocolectomy)
5-484 and 5-485 (rectum resections)
5-502 and 5-503 (anatomical liver resection)
5-512, 5-515, 5-518.4 and .5, 5-519 (biliary tract resections)
5-523, 5-524, 5-525, 5-527 and 5-529 (pancreas resections and draining procedures)
5-536, 5-538, 5-539 (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, 5-682 to 5-687 (gynecologic resections of uterus, ovary, cervix)
5-87 and 5-88 (breast surgery)
- Younger than 18 years
- Currently pregnant or breastfeeding (anamnestically)
- 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 >3.
- Patients unable to walk, run, step, or cycle.
- Patients with an acute (on chronic) cardiovascular disease
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)
- Suspected dissecting aneurysm
- Uncontrolled acutely decompensated HF (acute pulmonary edema) (J81)
- HR>120 bpm, BP> 180mmHg sys, 120mmHg diastolic
-Patients with an acute (on chronic) pulmonary disease
-Acute pulmonary embolism (I26)
-Resting dyspnea (Frequency>25)
-Exertional dyspnea after less than 2 floors of step walking
-Chest pain when resting
-Severe hypoxemia at rest or acute respiratory failure (J80)
-An acute, non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (such as infection, renal failure, or thyrotoxicosis)
-Mental impairment leading to inability to cooperate
-Patients under guardianship or imprisoned
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease of the overall 90-day morbidity rate from 60% to 45% (DC I-V).<br><br>
- Secondary Outcome Measures
Name Time Method 90-day morbidity & mortality<br>1-year survival and way of living<br>Length of stay (normal ward, IMC, ICU)<br>Hospital readmission rates<br>Compliance rates to The PrehApp<br>Device failures<br>Vigilance reporting during exercising before surgery with a special focus on cardiac events<br>Vigilance reporting after surgery<br>Cost implications by implementing prehabilitation<br>