Back to resultsPrehabilitation of Elderly Patients With Frailty Syndrome Before Elective Surgery (PRAEP-GO)
Primary Purpose
Frailty, Frail Elderly
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Prehabilitation- new form of care
Sponsored by
About this trial
This is an interventional supportive care trial for Frailty focused on measuring Prehabilitation, Physiotherapy, Exercise Therapy, Rehabilitation, Nutritional Intervention, Multidisciplinary Intervention, Frailty, Surgery
Eligibility Criteria
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)
Sites / Locations
- Herz- und Diabetes ZentrumRecruiting
- Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin BerlinRecruiting
- Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin BerlinRecruiting
- Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbHRecruiting
- BundeswehrkrankenhausRecruiting
- CARITAS Klinik Maria HeimsuchungRecruiting
- Dominikus-KrankenhausRecruiting
- Evangelisches Krankenhaus HubertusRecruiting
- Humboldt-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
- Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbHRecruiting
- Martin-Luther-Krankenhaus
- Sankt Joseph KrankenhausRecruiting
- Unfallkrankenhaus BerlinRecruiting
- Klinikum Frankfurt Oder GmbH
- Universitätsmedizin GreifswaldRecruiting
- Universitätsklinikum Hamburg-EppendorfRecruiting
- Sana Kliniken SommerfeldRecruiting
- Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universität zu LübeckRecruiting
- Klinikum der Universität München, LMU Campus GroßhadernRecruiting
- Klinikum rechts der Isar - Technische Universität MünchenRecruiting
- München Klinik BogenhausenRecruiting
- Havelland Kliniken GmbH - Klinik NauenRecruiting
- Havelland Kliniken-Klinik Rathenow
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Prehabilitation
Standard of Care
Arm Description
Prefrail and frail patients receive prehabilitation (new form of care)
Prefrail and frail patients receive no prehabilitation, but receive standard of care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Neurocognitive Disorder (NCD)
New diagnosis of mild/major Neurocognitive Disorder at 3 and 12 months. The diagnosis is made based on DSM-V criteria including a multi-component cognitive test battery comparing with baseline testing and comparison to a non-surgical observational control group.
Suspected Neurocognitive disorder by MiniCog
Dementia 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 suspicion of dementia.
Suspected Dementia by MOCA
Dementia is suspected by a Montreal Cognitive Assessment (MOCA) according to normative age-adjusted values. The MOCA consists of 13 items which are rated on a scale between 0 and 30 points.
Suspected postoperative neurocognitive disorder (POCD)
The non-computerized neuropsychological Trail Making Test are used as indicator screening test for relevant cognitive change after surgery. An increase of >55 seconds in TMT-B test performance at three and/or 12 months after surgery compared to baseline is set as cut off.
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.
Polypharmacy
Measured by number of drug agents
Alcohol Use
Measured by number of drug agents
Tobacco Use
Measured by Fagerstrom (Fagerstrom & Schneider, 1989)
Intraoperative Neuromonitoring
Monitoring of electroencephalography during surgery
Result of surgery
Incidence of complications (intra- and post-operative)
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.
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)
Arm circumference
Arm circumference is measured in a standardized position and documented in centimeter.
Calf circumference
Calf circumference is measured in a standardized position and documented in centimeter.
Mini Nutritional Assessment-Short
Nutritional Status is measured using Mini Nutritional Assessment-Short-form (MNA-SF).
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).
Independence of Functional Status
Assessment of the patient's independence in mobilization, i.e. mobilization in daily living without personnel or device support.
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.
Function of the respiratory system
The function of the respiratory system is assessed by expiratory peak flow measurement as surrogate parameter.
Depression
Depression is measured by frequency of depressive symptoms; Patient Health Questionnaire-8 (PHQ-8)]
Anxiety
Anxiety is measured frequency of anxiety symptoms; Generalized Anxiety Disorder Scale-7 (GAD-7)
Frequency of depressive and anxiety symptoms
Frequency of depressive and anxiety symptoms; Patient Health Questionnaire-4 (PHQ-4)]
Health related quality of life
Health related quality of life is measured with EQ-5D-5L questionnaire.
Patient-reported Functioning and Disability (WHO Disability Assessment) Schedule)
Patient-reported functioning and disability is measured by patient self report of functioning and disability due to health conditions; WHO Disability Assessment Schedule (WHODAS 2.0, 12-item version)
Proxy-reported Functioning and Disability (WHO Disability Assessment) Schedule)
Proxy-reported Functioning and Disability is measured by Proxy-rated functioning and disability due to health conditions; WHO Disability Assessment Schedule (WHODAS 2.0, 12-item Version)
Falls
Incidence of falls
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.
Social situation measurement 1
The social situation 1 of the patient is measured by a Questionnaire for Social Situation (SOS, Subscales 1 and 2).
Social situation measurement 2
The social situation 2 of the patient is measured by BSSS, 8-items
Pain: Numeric rating scale
Pain is measured with a pain score Numeric rating scale (0-10), a higher score indicates more pain.
Satisfaction with the prehabilitation and overall process: 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.
Loneliness
Frequency of sensations of loneliness; 3-item UCLA Loneliness Scale
Survival
Data from patient records and residents' registration
Full Information
NCT ID
NCT04418271
First Posted
May 19, 2020
Last Updated
February 9, 2023
Sponsor
Charite University, Berlin, Germany
Collaborators
Ludwig-Maximilians - University of Munich, The Institute for Medical Information Processing, Biometry, and Epidemiology, Technische Universität Berlin, BARMER
1. Study Identification
Unique Protocol Identification Number
NCT04418271
Brief Title
Prehabilitation of Elderly Patients With Frailty Syndrome Before Elective Surgery (PRAEP-GO)
Official Title
Prehabilitation of Elderly Frail or Pre-frail Patients Prior to Elective Surgery - a Randomized Controlled Multicenter Study (PRAEP-Go)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Ludwig-Maximilians - University of Munich, The Institute for Medical Information Processing, Biometry, and Epidemiology, Technische Universität Berlin, BARMER
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Frail Elderly
Keywords
Prehabilitation, Physiotherapy, Exercise Therapy, Rehabilitation, Nutritional Intervention, Multidisciplinary Intervention, Frailty, Surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prehabilitation
Arm Type
Experimental
Arm Description
Prefrail and frail patients receive prehabilitation (new form of care)
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Prefrail and frail patients receive no prehabilitation, but receive standard of care
Intervention Type
Behavioral
Intervention Name(s)
Prehabilitation- new form of care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Degree of care dependency
Description
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.
Time Frame
Up to one year
Secondary Outcome Measure Information:
Title
Neurocognitive Disorder (NCD)
Description
New diagnosis of mild/major Neurocognitive Disorder at 3 and 12 months. The diagnosis is made based on DSM-V criteria including a multi-component cognitive test battery comparing with baseline testing and comparison to a non-surgical observational control group.
Time Frame
Up to one year
Title
Suspected Neurocognitive disorder by MiniCog
Description
Dementia 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 suspicion of dementia.
Time Frame
Up to one year
Title
Suspected Dementia by MOCA
Description
Dementia is suspected by a Montreal Cognitive Assessment (MOCA) according to normative age-adjusted values. The MOCA consists of 13 items which are rated on a scale between 0 and 30 points.
Time Frame
Up to one year
Title
Suspected postoperative neurocognitive disorder (POCD)
Description
The non-computerized neuropsychological Trail Making Test are used as indicator screening test for relevant cognitive change after surgery. An increase of >55 seconds in TMT-B test performance at three and/or 12 months after surgery compared to baseline is set as cut off.
Time Frame
Up to one year
Title
Frailty
Description
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.
Time Frame
Up to one year
Title
Polypharmacy
Description
Measured by number of drug agents
Time Frame
Up to one year
Title
Alcohol Use
Description
Measured by number of drug agents
Time Frame
Up to one year
Title
Tobacco Use
Description
Measured by Fagerstrom (Fagerstrom & Schneider, 1989)
Time Frame
Up to one year
Title
Intraoperative Neuromonitoring
Description
Monitoring of electroencephalography during surgery
Time Frame
During surgery
Title
Result of surgery
Description
Incidence of complications (intra- and post-operative)
Time Frame
Up to one year
Title
Autonomy Preference
Description
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.
Time Frame
At the beginning of the observation
Title
Extent of involvement in shared decision-making process
Description
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)
Time Frame
At the beginning of the observation
Title
Arm circumference
Description
Arm circumference is measured in a standardized position and documented in centimeter.
Time Frame
Up to one year
Title
Calf circumference
Description
Calf circumference is measured in a standardized position and documented in centimeter.
Time Frame
Up to one year
Title
Mini Nutritional Assessment-Short
Description
Nutritional Status is measured using Mini Nutritional Assessment-Short-form (MNA-SF).
Time Frame
Up to one year
Title
Sarcopenia
Description
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).
Time Frame
Up to one year
Title
Independence of Functional Status
Description
Assessment of the patient's independence in mobilization, i.e. mobilization in daily living without personnel or device support.
Time Frame
Up to one year
Title
Functional endurance
Description
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.
Time Frame
Up to one year
Title
Function of the respiratory system
Description
The function of the respiratory system is assessed by expiratory peak flow measurement as surrogate parameter.
Time Frame
Up to one year
Title
Depression
Description
Depression is measured by frequency of depressive symptoms; Patient Health Questionnaire-8 (PHQ-8)]
Time Frame
Up to one year
Title
Anxiety
Description
Anxiety is measured frequency of anxiety symptoms; Generalized Anxiety Disorder Scale-7 (GAD-7)
Time Frame
Up to one year
Title
Frequency of depressive and anxiety symptoms
Description
Frequency of depressive and anxiety symptoms; Patient Health Questionnaire-4 (PHQ-4)]
Time Frame
Up to one year
Title
Health related quality of life
Description
Health related quality of life is measured with EQ-5D-5L questionnaire.
Time Frame
Up to one year
Title
Patient-reported Functioning and Disability (WHO Disability Assessment) Schedule)
Description
Patient-reported functioning and disability is measured by patient self report of functioning and disability due to health conditions; WHO Disability Assessment Schedule (WHODAS 2.0, 12-item version)
Time Frame
Up to one year
Title
Proxy-reported Functioning and Disability (WHO Disability Assessment) Schedule)
Description
Proxy-reported Functioning and Disability is measured by Proxy-rated functioning and disability due to health conditions; WHO Disability Assessment Schedule (WHODAS 2.0, 12-item Version)
Time Frame
Up to one year
Title
Falls
Description
Incidence of falls
Time Frame
Up to one year
Title
Fear of Falling
Description
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.
Time Frame
Up to one year
Title
Social situation measurement 1
Description
The social situation 1 of the patient is measured by a Questionnaire for Social Situation (SOS, Subscales 1 and 2).
Time Frame
Up to one year
Title
Social situation measurement 2
Description
The social situation 2 of the patient is measured by BSSS, 8-items
Time Frame
Up to one year
Title
Pain: Numeric rating scale
Description
Pain is measured with a pain score Numeric rating scale (0-10), a higher score indicates more pain.
Time Frame
Up to one year
Title
Satisfaction with the prehabilitation and overall process: ZUF-8
Description
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.
Time Frame
Up to one year
Title
Loneliness
Description
Frequency of sensations of loneliness; 3-item UCLA Loneliness Scale
Time Frame
Up to one year
Title
Survival
Description
Data from patient records and residents' registration
Time Frame
Up to one year
Other Pre-specified Outcome Measures:
Title
Length of stay Intensive Care Unit
Description
Intensive care unit length of stay describes every day spent in an ICU bed.
Time Frame
Participants are followed up for the duration of rehabilitation, an expected average of 1 day]
Title
Admission Intensive Care Unit (ICU) Admission rate on Intensive Care Unit (ICU)
Description
Admission rate (planned / unplanned) on ICU
Time Frame
Participants are followed up for the duration of rehabilitation, an expected average of 1 day]
Title
Duration of hospital stay
Description
Time in hospital
Time Frame
Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
Title
Adverse Discharge Disposition
Description
Adverse discharge disposition other than to home and planned rehabilitation facility.
Time Frame
Participants are followed up after hospital discharge for 1 day
Title
Necessity for follow-up treatment and rehabilitation
Description
Assessment if a follow-up treatment or rehabilitation is necessary after the hospital stay.
Time Frame
Up to one year
Title
Count of new discharge diagnoses
Description
New medical diagnoses at hospital discharge compared to baseline are assessed.
Time Frame
Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
Title
Count of new discharge medication
Description
New medication at hospital discharge compared to baseline is assessed.
Time Frame
Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
Title
Duration of rehabilitation
Description
Patient record data, discharge letter
Time Frame
Participants are followed up for the duration of rehabilitation, an expected average of 25 days]
Title
Health economic benefit
Description
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.
Time Frame
Up to one year
Title
Adequacy of exercise interventions
Description
Assessment of the appropriateness of the quantity and quality of the exercise interventions compared to exercise prescription guidelines.
Time Frame
Up to one year
Title
Evaluation of the nutritional intervention
Description
Questionnaire on operability of the nutritional intervention and dietary records
Time Frame
Up to three weeks
Title
Anesthesia duration
Description
Measured form anesthesia induction until stop of anesthesia (Patient records)
Time Frame
During surgery
Title
Preoperative Cognitive Impairment
Description
For NCD diagnosis at baseline (Preoperative Cognitive Impairment) the same distinction criteria for mild and major NCD were applied, although here formal neurocognitive test performance at baseline was compared to the corresponding mean baseline value in the non-surgical control group.
Time Frame
At baseline
Title
Assistive Devices (Hilfsmittel)
Description
The need of any aid and device that is designed, made, or adapted to assist a patient perform a particular task.
Time Frame
Up to one year
Title
Treatment (Heilmittel)
Description
The need of a substance or method for curing an illness.
Time Frame
Up to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Spies, MD, Prof.
Phone
+49 30 450 531012
Email
claudia.spies@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Spies, Prof., MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Herz- und Diabetes Zentrum
City
Bad Oeynhausen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sascha Treskatsch, MD. Prof.
Phone
+49 30 450 55 15 22
Email
sascha.treskatsch@charite.de
First Name & Middle Initial & Last Name & Degree
Sascha Treskatsch, MD, Prof.
Facility Name
Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Spies, MD, Prof.
Phone
+49 30 450 55 10 01
Email
claudia.spies@charite.de
First Name & Middle Initial & Last Name & Degree
Claudia Spies, MD, Prof.
First Name & Middle Initial & Last Name & Degree
Stefan Schaller, MD, Prof.
First Name & Middle Initial & Last Name & Degree
Katrin Schmidt, MD
Facility Name
Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Name
Bundeswehrkrankenhaus
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Name
CARITAS Klinik Maria Heimsuchung
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Name
Dominikus-Krankenhaus
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Name
Evangelisches Krankenhaus Hubertus
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Name
Humboldt-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
City
Berlin
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Name
Martin-Luther-Krankenhaus
City
Berlin
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Sankt Joseph Krankenhaus
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Name
Unfallkrankenhaus Berlin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Frankfurt Oder GmbH
City
Frankfurt/Oder
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitätsmedizin Greifswald
City
Greifswald
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Name
Sana Kliniken Sommerfeld
City
Kremmen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universität zu Lübeck
City
Lübeck
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum der Universität München, LMU Campus Großhadern
City
München
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum rechts der Isar - Technische Universität München
City
München
Country
Germany
Individual Site Status
Recruiting
Facility Name
München Klinik Bogenhausen
City
München
Country
Germany
Individual Site Status
Recruiting
Facility Name
Havelland Kliniken GmbH - Klinik Nauen
City
Nauen
ZIP/Postal Code
14641
Country
Germany
Individual Site Status
Recruiting
Facility Name
Havelland Kliniken-Klinik Rathenow
City
Rathenow
ZIP/Postal Code
14712
Country
Germany
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35668532
Citation
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.
Results Reference
derived
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Prehabilitation of Elderly Patients With Frailty Syndrome Before Elective Surgery (PRAEP-GO)
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