Prehabilitation of Elderly Patients With Frailty Syndrome Before Elective Surgery (PRAEP-GO)
NCT ID: NCT04418271
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
1199 participants
INTERVENTIONAL
2020-06-30
2024-12-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The objective of PRÄP-GO is to establish and employ a suitable preoperative case-care management system to improve the short and long-term outcome of elderly surgical patients with signs of a frailty syndrome, improving postoperative quality of life and reducing care dependency by a three-week individualized prehabilitation program.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Home-based Prehabilitation for Elderly Patients
NCT03964363
Prevalence Study : Elderly Patients and Rehabilitation in ICU. Impact of Frailty.
NCT03326635
Feasibility of an Extended Test Battery and Influencing Factors for Detecting Frailty
NCT04190329
Detection, Evaluation and Monitoring of Frailties in the Elderly (FRAGING)
NCT04992286
Validation of a Record-based Frailty Assessment According to the Multidimensional Prognostic Index
NCT03794674
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prehabilitation
Prefrail and frail patients receive prehabilitation (new form of care)
Prehabilitation- new form of care
The participants in the intervention group take part in a shared decision-making (SDM) conference to plan the intervention. The therapeutic content of the prehabilitation is defined individually for each patient in the SDM conference. Prehabilitation will be a structured and individually tailored 3-week program.
Standard of Care
Prefrail and frail patients receive no prehabilitation, but receive standard of care
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Prehabilitation- new form of care
The participants in the intervention group take part in a shared decision-making (SDM) conference to plan the intervention. The therapeutic content of the prehabilitation is defined individually for each patient in the SDM conference. Prehabilitation will be a structured and individually tailored 3-week program.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Consent by Patient or Legal Representative
* Elective surgery planned
* Expected anesthesia duration≥ 60 min
* Statutory health insurance
* Frailty syndrome (≥1 positive out of 5 standardized parameters according to the Physical Frailty Phenotype according to Fried et. al.)
Exclusion Criteria
* Intracranial interventions
* Moribund patients (palliative situation)
* Not enough language skills
* Participation in another interventional rehabilitation study or other interventional clinical trial that has not been approved by the study management committee (Exception: Participation in adjuvant intervention study)
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ludwig-Maximilians - University of Munich, The Institute for Medical Information Processing, Biometry, and Epidemiology
UNKNOWN
Technische Universität Berlin
OTHER
BARMER
OTHER
Charite University, Berlin, Germany
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Claudia Spies
Univ.- Prof. Dr. Claudia Spies
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Claudia Spies, Prof., MD
Role: STUDY_CHAIR
Charite University, Berlin, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Herz- und Diabetes Zentrum
Bad Oeynhausen, , Germany
Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
Berlin, , Germany
Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
Berlin, , Germany
Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
Berlin, , Germany
Bundeswehrkrankenhaus
Berlin, , Germany
CARITAS Klinik Maria Heimsuchung
Berlin, , Germany
Dominikus-Krankenhaus
Berlin, , Germany
Evangelisches Krankenhaus Hubertus
Berlin, , Germany
Humboldt-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
Berlin, , Germany
Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH
Berlin, , Germany
Martin-Luther-Krankenhaus
Berlin, , Germany
Sankt Joseph Krankenhaus
Berlin, , Germany
Unfallkrankenhaus Berlin
Berlin, , Germany
Klinikum Frankfurt Oder GmbH
Frankfurt (Oder), , Germany
Universitätsmedizin Greifswald
Greifswald, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Sana Kliniken Sommerfeld
Kremmen, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universität zu Lübeck
Lübeck, , Germany
Klinikum der Universität München, LMU Campus Großhadern
München, , Germany
Klinikum rechts der Isar - Technische Universität München
München, , Germany
München Klinik Bogenhausen
München, , Germany
Havelland Kliniken GmbH - Klinik Nauen
Nauen, , Germany
Havelland Kliniken-Klinik Rathenow
Rathenow, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Eckhardt H, Quentin W, Silzle J, Busse R, Rombey T. Cost-effectiveness of prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO) versus usual care - Protocol for a health economic evaluation alongside a randomized controlled trial. BMC Geriatr. 2024 Mar 6;24(1):231. doi: 10.1186/s12877-024-04833-5.
Schaller SJ, Kiselev J, Loidl V, Quentin W, Schmidt K, Morgeli R, Rombey T, Busse R, Mansmann U, Spies C; PRAEP-GO consortium,; PRAEP-GO investigators. Prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO): study protocol for a randomized, controlled, outcome assessor-blinded trial. Trials. 2022 Jun 6;23(1):468. doi: 10.1186/s13063-022-06401-x.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1253-4820
Identifier Type: OTHER
Identifier Source: secondary_id
PRAEP-GO
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.