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

Prehabilitation of Elderly Frail or Pre-frail Patients Prior to Elective Surgery - a Randomized Controlled Multicenter Study (PRAEP-Go)

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.

Study Overview

• Status: Completed
• Conditions: Frailty; Frail Elderly
• Intervention / Treatment: Behavioral: Prehabilitation- new form of care

• Study Type: Interventional
• Enrollment (Actual): 1199
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Oeynhausen, Germany
    • Herz- und Diabetes Zentrum
  • Berlin, Germany
    • Unfallkrankenhaus Berlin
  • Berlin, Germany, 13353
    • Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
  • Berlin, Germany, 12203
    • Department of Anesthesiology and Operative Intensive Care Medicine (CBF), 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
  • Frankfurt/Oder, Germany
    • Klinikum Frankfurt Oder GmbH
  • Greifswald, Germany
    • Universitätsmedizin Greifswald
  • Hamburg, Germany
    • Universitätsklinikum Hamburg-Eppendorf
  • Kremmen, Germany
    • Sana Kliniken Sommerfeld
  • Lübeck, Germany
    • Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universität zu Lübeck
  • München, Germany
    • Munchen Klinik Bogenhausen
  • München, Germany
    • Klinikum der Universität München, LMU Campus Großhadern
  • München, Germany
    • Klinikum rechts der Isar - Technische Universität München
  • Nauen, Germany, 14641
    • Havelland Kliniken GmbH - Klinik Nauen
  • Rathenow, Germany, 14712
    • Havelland Kliniken-Klinik Rathenow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Study patients:

Inclusion Criteria:

• 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.)

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prehabilitation; Prefrail and frail patients receive prehabilitation (new form of care)	Behavioral: 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.
No Intervention: Standard of Care; Prefrail and frail patients receive no prehabilitation, but receive standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty	Frailty is operationalized using modified Fried frailty criteria. Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) represent robust (0), pre-frail (1-2), and frail (3-5) health status.	Up to one year
Autonomy Preference	Extent of patients' autonomy preference concerning medical decisions; Autonomy-Preference-Index, modified German version (API-Dm). The scale consists of a 11-item questionnaire with 4 questions on preferred autonomy in health-related decisions and 7 items on information preference. The total results of the API and both subscales are transformed into a 0 - 100 scale with higher values indicating higher levels on autonomy and information preference, respectively.	At the beginning of the observation
Extent of involvement in shared decision-making process	Extent of patients, relatives and health professionals' involvement in shared decision-making process; 9-Item Shared Decision Making Questionnaire (SDM-Q-9/SDM-Q-Doc)	At the beginning of the observation
Arm circumference	Arm circumference is measured in a standardized position and documented in centimeter.	Up to one year
Calf circumference	Calf circumference is measured in a standardized position and documented in centimeter.	Up to one year
Functional endurance	Functional endurance is measured using the 2-Minute-Step-Test (2-MST). The patient steps in place, raising each leg to a marker. The markers height is derived from biometrical measures of the patient. The assessor counts each step of the right leg in which the knee of the patient passes the marker. Higher counts of steps indicates better functional endurance.	Up to one year
Function of the respiratory system	The function of the respiratory system is assessed by expiratory peak flow measurement as surrogate parameter.	Up to one year
Depression	Depression is measured by frequency of depressive symptoms; Patient Health Questionnaire-8 (PHQ-8)]	Up to one year
Anxiety	Anxiety is measured frequency of anxiety symptoms; Generalized Anxiety Disorder Scale-7 (GAD-7)	Up to one year
Health related quality of life	Health related quality of life is measured with EQ-5D-5L questionnaire.	Up to one year
Falls	Incidence of falls	Up to one year
Fear of Falling	Activities-Specific Balance Confidence (ABC)-6-Scale. The scale consists of 6 questions who are rated on a 0-100 NRS-scale. The total result of the ABC-6-scale comprises of the average of all 6 items.	Up to one year
Length of stay Intensive Care Unit	Intensive care unit length of stay describes every day spent in an ICU bed.	Participants are followed up for the duration of rehabilitation, an expected average of 1 day]
Admission Intensive Care Unit (ICU) Admission rate on Intensive Care Unit (ICU)	Admission rate (planned / unplanned) on ICU	Participants are followed up for the duration of rehabilitation, an expected average of 1 day]
Duration of hospital stay	Time in hospital	Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
Nutritional Status	Changes of nutritional status after elective surgery.	Up to one year
Barthel Index	Level of care dependency after surgery reported as Barthel Index	Up to one year
Change in NBA score	Assessment results according to the German dependency assessment (= "Neues Begutachtungs-Assessment" (NBA)) (Wingenfeld et al., 2008) using the results of the assessments on the scale from 0 to 100 points	Up to one year
NBA domain change	Change in individual domains of the German dependency assessment (= "Neues Begutachtungs-Assessment" (NBA)).	Up to one year
Surrogate for Neurocognitive Disorder (NCD)	Frequency of neurocognitive vulnerability at 3 or 12 months as surrogate for NCD is measured as composite score: Frequency of cognitive impairment/vulnerability is calculated from a change in composite of MiniCog, ANT, TMT-B and MOCA; subjective concern (MMQ) and; IADL/ADL	Up to one year
Screening tool for cognitive vulnerability	Cognitive vulnerability is suspected by limited MiniCog-test result. The MiniCog consists of two items, the word recall test and the clock-drawing test. Performance in these test is rated on a scale ranging from 0 - 5, with <3 points indicating a cognitive vulnerability.	Up to one year
Dementia risk assessed by MOCA	Dementia risk is assessed by Montreal Cognitive Assessment (MOCA-30) deterioration (change) and its absolute value if < 26.	Up to one year
Delirium	Delirium as perioperative complication assessed until hospital discharge using billing data.	Up to one year
Perioperative complications by Clavien-Dindo	Perioperative complications assessed using Clavien Dindo till hospital discharge	Up to hospital discharge
Every mobility	Level of everyday mobility using Life-Space Assessment (LSA)	Up to one year
Change in body weight	Changes in body weight measured in kg.	Up to one year
Instrumental Activities of daily living (IADL)	Instrumental Activities of daily living (IADL) using the questionnaire by Lawton and Brody.	Up to one year
Disability by WHODAS 2.0	Patient- or proxy-reported functioning and disability is measured by the WHO Disability Assessment Schedule (WHODAS 2.0, 12-item version.	Up to one year
Satisfaction with the intervention: ZUF-8	The satisfaction of the patient is measured with the questionnaire on patient satisfaction (ZUF-8). The ZUF-8 is a questionnaire on patient satisfaction after treatment. It consists of 8 questions which results in a score between 0 and 24 points, with higher values.indicating higher levels of satisfaction.	Up to one year
Mortality	Data from patient records and residents' registration	Up to one year
Muscle strength	Muscle strength measured by handgrip strength	Up to one year
Functional mobility	Functional mobility is measured with gait speed over 15ft	Up to one year
Stair climbing speed	Stair climbing speed test	Up to one year
Timed Up & Go Test (TUG	Timed Up & Go Test (TUG) to test mobility and body balance	Up to one year
Postoperative functional mobility	Postoperative complication of mobilization speed measured with CHARMI	Up to one year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polypharmacy	Measured by number of drug agents	Up to one year
Tobacco Use	Measured by Fagerstrom (Fagerstrom & Schneider, 1989)	Up to one year
Social situation measurement 1	The social situation 1 of the patient is measured by a Questionnaire for Social Situation (SOS, Subscales 1 and 2).	Up to one year
Social situation measurement 2	The social situation 2 of the patient is measured by BSSS, 8-items	Up to one year
Pain: Numeric rating scale	Pain is measured with a pain score Numeric rating scale (0-10), a higher score indicates more pain.	Up to one year
Loneliness	Frequency of sensations of loneliness; 3-item UCLA Loneliness Scale	Up to one year
Adverse Discharge Disposition	Adverse discharge disposition other than to home and planned rehabilitation facility.	Participants are followed up after hospital discharge for 1 day
Necessity for follow-up treatment and rehabilitation	Assessment if a follow-up treatment or rehabilitation is necessary after the hospital stay.	Up to one year
Count of new discharge diagnoses	New medical diagnoses at hospital discharge compared to baseline are assessed.	Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
Count of new discharge medication	New medication at hospital discharge compared to baseline is assessed.	Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
Duration of rehabilitation	Patient record data, discharge letter	Participants are followed up for the duration of rehabilitation, an expected average of 25 days]
Health economic benefit	ScreeningThe health economic benefit of the intervention (prehabilitation) will be compared to standard of care in the German health care system using a health cost analysis framework.	Up to one year
Exercise adherence and planned prehabilitation composition	Assessment of the appropriateness of the quantity and quality of the exercise interventions compared to exercise prescription guidelines.	Up to one year
Patient support	Patient support by need/prescription of assistive devices ("Hilfsmittel") and therapeutic treatment ("Heilmittel").	Up to one year
Alcohol Use	Measured by Alcohol Use Disorders Identification Test (AUDIT-C)	Up to one year
Sarcopenia	Sarcopenia is evaluated as a composite measure by three criteria that are assessed: 1) low muscle strength (hand grip strength), 2) low muscle quantity (calf circumference) and 3) low physical performance (gait speed or TUG).	Up to one year

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Ludwig-Maximilians - University of Munich, The Institute for Medical Information Processing, Biometry, and Epidemiology; Technische Universität Berlin; BARMER
• Investigators: Study Chair: Claudia Spies, Prof., MD, Charite University, Berlin, Germany

Publications and helpful links

General Publications

• 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. Erratum In: Trials. 2023 Feb 14;24(1):111. doi: 10.1186/s13063-023-07106-5.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): December 19, 2024

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Prehabilitation, Physiotherapy, Exercise Therapy, Rehabilitation, Nutritional Intervention, Multidisciplinary Intervention, Frailty, Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: PRAEP-GO; U1111-1253-4820 (Other Identifier: Universal Trial Number (UTN))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No