Prehabilitation of Elderly Patients With Frailty Syndrome Before Elective Surgery (PRAEP-GO)

NCT04418271 | Completed

• 2 other identifiers: PRAEP-GOU1111-1253-4820
• Study Type: interventional
• Target: 1,199
• Locations: 1 country
• Sites: 23

Brief Summary

The aim of the study is to evaluate the effect of a shared decision-making conference and three-week prehabilitation program on the outcome "care dependency" one year after surgery. The cost-effectiveness of the intervention will also be evaluated in this N = 1400 patient, national multicenter, assessor-blinded, randomized, pragmatic, controlled, parallel-group, clinical trial. 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.

Conditions

Frailty; Frail Elderly

Keywords

Prehabilitation, Physiotherapy, Exercise Therapy, Rehabilitation, Nutritional Intervention, Multidisciplinary Intervention, Frailty, Surgery

Outcome Measures

Primary Outcomes (1)

• Degree of care dependency

  Assessment results in a degree of care dependency from personal help according to the German dependency assessment (= "Neues Begutachtungs-Assessment" (NBA)) (Wingenfeld et al., 2008). The results of the assessments ranges between 0 and 100 points, which are transformed into a 0-5 ordinal scale. Higher points in the assessments indicate higher demand of care dependency. Accordingly, higher numbers on the ordinal scale indicate a higher level of care dependency as defined in the German statutory care insurance program.

  Up to one year

Secondary Outcomes (35)

• Barthel Index

  Up to one year

• Change in NBA score

  Up to one year

• NBA domain change

  Up to one year

• Surrogate for Neurocognitive Disorder (NCD)

  Up to one year

• Screening tool for cognitive vulnerability

  Up to one year

Other Outcomes (16)

• Adverse Discharge Disposition

  Participants are followed up after hospital discharge for 1 day

• Necessity for follow-up treatment and rehabilitation

  Up to one year

• Count of new discharge diagnoses

  Participants are followed up for the duration of rehabilitation, an expected average of 7 days]

Study Arms (2)

Prehabilitation

EXPERIMENTAL

Prefrail and frail patients receive prehabilitation (new form of care)

Behavioral: Prehabilitation- new form of care

Standard of Care

NO INTERVENTION

Prefrail and frail patients receive no prehabilitation, but receive standard of care

Interventions

Prehabilitation- new form of care BEHAVIORAL

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.

Prehabilitation

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 70 years
• 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.)

You may not qualify if:

• Severe cardiac or pulmonary disease (NYHA IV, Gold IV)
• 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)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Ludwig-Maximilians - University of Munich, The Institute for Medical Information Processing, Biometry, and Epidemiology: collaborator
• Technische Universität Berlin: collaborator
• BARMER: collaborator

Study Sites (23)

Herz- und Diabetes Zentrum

Bad Oeynhausen, Germany

Location

Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH

Berlin, Germany

Location

Bundeswehrkrankenhaus

Berlin, Germany

Location

CARITAS Klinik Maria Heimsuchung

Berlin, Germany

Location

Dominikus-Krankenhaus

Berlin, Germany

Location

Evangelisches Krankenhaus Hubertus

Berlin, Germany

Location

Humboldt-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH

Berlin, Germany

Location

Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH

Berlin, Germany

Location

Martin-Luther-Krankenhaus

Berlin, Germany

Location

Sankt Joseph Krankenhaus

Berlin, Germany

Location

Unfallkrankenhaus Berlin

Berlin, Germany

Location

Klinikum Frankfurt Oder GmbH

Frankfurt (Oder), Germany

Location

Universitätsmedizin Greifswald

Greifswald, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Sana Kliniken Sommerfeld

Kremmen, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universität zu Lübeck

Lübeck, Germany

Location

Klinikum der Universität München, LMU Campus Großhadern

München, Germany

Location

Klinikum rechts der Isar - Technische Universität München

München, Germany

Location

München Klinik Bogenhausen

München, Germany

Location

Havelland Kliniken GmbH - Klinik Nauen

Nauen, 14641, Germany

Location

Havelland Kliniken-Klinik Rathenow

Rathenow, 14712, Germany

Location

Related Publications (3)

• Schone C, Fuchs TI, Kiselev J, Schmidt K, Schaller SJ, Spies C, Rombey T. Facilitators and barriers to participation in prehabilitation prior to orthopaedic elective surgery - a qualitative study with elderly (pre-)frail patients. BMC Geriatr. 2025 Nov 4;25(1):845. doi: 10.1186/s12877-025-06592-3.

  PMID: 41188708 DERIVED

• 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.

  PMID: 38448804 DERIVED

• 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.

  PMID: 35668532 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudia Spies, Prof., MD

  Charite University, Berlin, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.- Prof. Dr. Claudia Spies

Model Details: Patients with frailty syndrome (≥1 of the standardized parameters (Pre-Frail = 1-2; Frail≥3) according to Fried et al.(2001) are offered randomised participation in the new form of care.

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 5, 2020
• Study Start: June 30, 2020
• Primary Completion: August 1, 2024
• Study Completion: December 19, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (23)