DRKS00033612Not yet recruitingUnknown
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. - LUMOS
Goethe Universität Frankfurt am Main, Universitätsklinikum Frankfurt0 sites382 target enrollmentStarted: May 13, 2024Last updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 382
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (—)
- Sex
- All
Inclusion Criteria
- •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)
Exclusion Criteria
- •- 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
Investigators
Similar Trials
Not yet recruiting
Phase 3
A multicenter prospective randomized controlled trial: Comparison generic alginate Vs original alginate for symptoms controlled in the non-proton pump inhibitors responder GERDIn patients with gastroesophageal reflux disease, despite taking proton pump inhibitors But only 25.7% of symptoms could be controlled in 7 days and only 35.9% of GERD patients were found to have no heartburn symptoms over 28 days. Patients with GERD are chronic and affect their quality of life worse compared to normal people. which often affects sleep decreased vitality more pain in the body impaired sexual feelings and more anxiety.GERDTCTR20230119007Dr. Kawin Tangvoraphonkchai162
Not yet recruiting
Unknown
A multicenter prospective randomized controlled trial evaluating the usefulness of a real-time colonoscopy diagnostic support systemColorectal NeoplasmsJPRN-UMIN000051437Toho University Oomori hospital620
Recruiting
Not Applicable
A multicenter prospective randomized controlled trial of the usefulness of RDI for injection in esophageal ESDsuperficial esophageal cancerJPRN-UMIN000047475Keio University130
Recruiting
Not Applicable
A multicenter prospective randomized controlled trial of pass through biliary stricture using a novel, flexible-tip, torquable, angled tip guidewireJPRN-UMIN000029100niversity of Miyazaki90
Not yet recruiting
Not Applicable
A prospective multicenter randomized controlled trial for the effect of high-dose corticosteroid on refractory Mycoplasma Pneumoniae pneumonia in childreMycoplasma Pneumoniae pneumoniaJPRN-UMIN000031674agoya University Graduate School of Medicine, Department of Pediatrics / Developmental Pediatrics46