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.

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033612

Enrollment

382

Registered

2024-05-13

Start date

2025-11-13

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Patients before major surgeries (noncardia thoracic surgery, abdominal surgery (urologic, gynecologic, vascular, visceral), breast surgery 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 (en

Interventions

Group 1: Educational Prehabilitation with the Ready4OP App (Educational Tool): 3 to 6-week interventional aerobic interval training, 3-4 times per week to increase the aerobic capacity. Group 2: Contr

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Decrease of the overall 90-day morbidity rate from 60% to 45% (DC I-V).	—

Secondary

Measure	Time frame
90-day morbidity & mortality 1-year survival and way of living Length of stay (normal ward, IMC, ICU) Hospital readmission rates Compliance rates to The PrehApp Device failures Vigilance reporting during exercising before surgery with a special focus on cardiac events Vigilance reporting after surgery Cost implications by implementing prehabilitation	—

Countries

Germany

Contacts

Public ContactSvenja Sliwinski

Goethe Universität Frankfurt am Main, Universitätsklinikum Frankfurt

svenja.sliwinski@unimediizin-ffm.de0049 69 6301 87197

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Sep 12, 2026