FrailtyNCT04418271
Prehabilitation of Elderly Patients With Frailty Syndrome Before Elective Surgery (PRAEP-GO)
A study testing Prehabilitation- new form of care in people with Frailty and Frail Elderly, run by Charite University, Berlin, Germany at 23 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frailty, Frail Elderly
- What is being tested?
- Prehabilitation- new form of care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,199 participants
- Where
- 23 sitesGermany
- Study dates
- 30 Jun 2020to 19 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.)
Who cannot join
- 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)
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Germany23 sites
Herz- und Diabetes Zentrum
Bad Oeynhausen
Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
Berlin, 12203
Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
Berlin, 13353
Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
Berlin
Bundeswehrkrankenhaus
Berlin
CARITAS Klinik Maria Heimsuchung
Berlin
Dominikus-Krankenhaus
Berlin
Evangelisches Krankenhaus Hubertus
Berlin
Humboldt-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
Berlin
Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH
Berlin
Martin-Luther-Krankenhaus
Berlin
Sankt Joseph Krankenhaus
Berlin
Unfallkrankenhaus Berlin
Berlin
Klinikum Frankfurt Oder GmbH
Frankfurt (Oder)
Universitätsmedizin Greifswald
Greifswald
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Sana Kliniken Sommerfeld
Kremmen
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universität zu Lübeck
Lübeck
Klinikum der Universität München, LMU Campus Großhadern
München
Klinikum rechts der Isar - Technische Universität München
München
München Klinik Bogenhausen
München
Havelland Kliniken GmbH - Klinik Nauen
Nauen, 14641
Havelland Kliniken-Klinik Rathenow
Rathenow, 14712
About this study
Official title: 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.
- Conditions
- Frailty, Frail Elderly
- Being tested
- Prehabilitation- new form of care
- Keywords
- Prehabilitation, Physiotherapy, Exercise Therapy, Rehabilitation, Nutritional Intervention, Multidisciplinary Intervention, Frailty, Surgery
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation- new form of careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Prefrail and frail patients receive prehabilitation (new form of care) Receives: Behavioral: Prehabilitation- new form of care |
| Standard of Care | No intervention | Prefrail and frail patients receive no prehabilitation, but receive standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to one year
Secondary outcomes (35)
Barthel Index
Level of care dependency after surgery reported as Barthel Index
Measured: 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
Measured: Up to one year
NBA domain change
Change in individual domains of the German dependency assessment (= "Neues Begutachtungs-Assessment" (NBA)).
Measured: 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
Measured: 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.
Measured: 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.
Measured: Up to one year
Delirium
Delirium as perioperative complication assessed until hospital discharge using billing data.
Measured: Up to one year
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.
Measured: Up to one year
Perioperative complications by Clavien-Dindo
Perioperative complications assessed using Clavien Dindo till hospital discharge
Measured: Up to hospital discharge
Every mobility
Level of everyday mobility using Life-Space Assessment (LSA)
Measured: 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.
Measured: 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)
Measured: At the beginning of the observation
Arm circumference
Arm circumference is measured in a standardized position and documented in centimeter.
Measured: Up to one year
Calf circumference
Calf circumference is measured in a standardized position and documented in centimeter.
Measured: Up to one year
Nutritional Status
Changes of nutritional status after elective surgery.
Measured: Up to one year
Change in body weight
Changes in body weight measured in kg.
Measured: Up to one year
Instrumental Activities of daily living (IADL)
Instrumental Activities of daily living (IADL) using the questionnaire by Lawton and Brody.
Measured: 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.
Measured: 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.
Measured: Up to one year
Depression
Depression is measured by frequency of depressive symptoms; Patient Health Questionnaire-8 (PHQ-8)]
Measured: Up to one year
Anxiety
Anxiety is measured frequency of anxiety symptoms; Generalized Anxiety Disorder Scale-7 (GAD-7)
Measured: Up to one year
Health related quality of life
Health related quality of life is measured with EQ-5D-5L questionnaire.
Measured: 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.
Measured: Up to one year
Falls
Incidence of falls
Measured: 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.
Measured: 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.
Measured: Up to one year
Mortality
Data from patient records and residents' registration
Measured: Up to one year
Muscle strength
Muscle strength measured by handgrip strength
Measured: Up to one year
Functional mobility
Functional mobility is measured with gait speed over 15ft
Measured: Up to one year
Stair climbing speed
Stair climbing speed test
Measured: Up to one year
Timed Up & Go Test (TUG
Timed Up \& Go Test (TUG) to test mobility and body balance
Measured: Up to one year
Postoperative functional mobility
Postoperative complication of mobilization speed measured with CHARMI
Measured: Up to one year
Length of stay Intensive Care Unit
Intensive care unit length of stay describes every day spent in an ICU bed.
Measured: 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
Measured: Participants are followed up for the duration of rehabilitation, an expected average of 1 day]
Duration of hospital stay
Time in hospital
Measured: Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start30 Jun 2020
- Primary completion1 Aug 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, Technische Universität Berlin, BARMER
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, Prof., MD, Study chair, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418271
- Sponsor's protocol ID
- PRAEP-GO
- Other IDs
- U1111-1253-4820
- Status last verified
- Feb 2025
- First submitted
- 19 May 2020
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spies C, Schmidt K, Kiselev J, Buchka S, Blobner M, Borchers F, Fabian M, Loidl V, Marschall U, Morgeli R, Nau C, Otto M, Rombey T, Saller T, Schulz M, Treskatsch S, Busse R, Mansmann U, Schaller SJ; PRAEP-GO consortium and PRAEP-GO investigators. Supervised multimodal prehabilitation of older patients with frailty or prefrailty before elective surgery: a multicentre randomised controlled outcome assessor-blinded trial. Lancet Healthy Longev. 2026 Sep 15:100899. doi: 10.1016/j.lanhl.2026.100899. Online ahead of print.
PubMed 42743945Rombey T, Eckhardt H, Quentin W, Weber Z, Buchka S, Kiselev J, Loidl V, Mansmann U, Schaller SJ, Schmidt K, Spies C, Busse R, Schoner L. Cost-effectiveness of prehabilitation for elderly (pre-)frail patients prior to elective surgery compared to standard care - an economic evaluation from a societal perspective. BMC Med. 2026 May 21;24(1):326. doi: 10.1186/s12916-026-04933-6.
PubMed 42163295Schone 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.
PubMed 41188708Eckhardt 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.
PubMed 38448804Schaller 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.
PubMed 35668532
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation of Elderly Frail or Pre-frail Patients Prior to Elective Surgery - a Randomized Controlled Multicenter Study (PRAEP-Go)
- ClinicalTrials.gov ID
- NCT04418271
- Acronym / sponsor ID
- PRAEP-GO
- Conditions
- Frailty, Frail Elderly
- Keywords
- Prehabilitation, Physiotherapy, Exercise Therapy, Rehabilitation, Nutritional Intervention, Multidisciplinary Intervention, Frailty, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,199 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, Technische Universität Berlin, BARMER
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Behavioral: Prehabilitation- new form of carePrefrail and frail patients receive prehabilitation (new form of care) |
| Standard of Care | No intervention | –Prefrail and frail patients receive no prehabilitation, but receive standard of care |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age ≥ 70 years
- Consent by Patient or Legal Representative
- Elective surgery planned
- Expected anesthesia duration≥ 60 min
- Statutory health insurance
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation- new form of careThe 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. | Behavioural | Prehabilitation |
Primary outcome
Degree of care dependency
Time frame: Up to one year
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.
35 secondary outcomes
Barthel Index
Time frame: Up to one year
Change in NBA score
Time frame: Up to one year
NBA domain change
Time frame: Up to one year
Surrogate for Neurocognitive Disorder (NCD)
Time frame: Up to one year
Screening tool for cognitive vulnerability
Time frame: Up to one year
Dementia risk assessed by MOCA
Time frame: Up to one year
Delirium
Time frame: Up to one year
Frailty
Time frame: Up to one year
Perioperative complications by Clavien-Dindo
Time frame: Up to hospital discharge
Every mobility
Time frame: Up to one year
Autonomy Preference
Time frame: At the beginning of the observation
Extent of involvement in shared decision-making process
Time frame: At the beginning of the observation
Arm circumference
Time frame: Up to one year
Calf circumference
Time frame: Up to one year
Nutritional Status
Time frame: Up to one year
Change in body weight
Time frame: Up to one year
Instrumental Activities of daily living (IADL)
Time frame: Up to one year
Functional endurance
Time frame: Up to one year
Function of the respiratory system
Time frame: Up to one year
Depression
Time frame: Up to one year
Anxiety
Time frame: Up to one year
Health related quality of life
Time frame: Up to one year
Disability by WHODAS 2.0
Time frame: Up to one year
Falls
Time frame: Up to one year
Fear of Falling
Time frame: Up to one year
Satisfaction with the intervention: ZUF-8
Time frame: Up to one year
Mortality
Time frame: Up to one year
Muscle strength
Time frame: Up to one year
Functional mobility
Time frame: Up to one year
Stair climbing speed
Time frame: Up to one year
Timed Up & Go Test (TUG
Time frame: Up to one year
Postoperative functional mobility
Time frame: Up to one year
Length of stay Intensive Care Unit
Time frame: 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)
Time frame: Participants are followed up for the duration of rehabilitation, an expected average of 1 day]
Duration of hospital stay
Time frame: Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Derived from this study: PubMed 42743945Spies C, Schmidt K, Kiselev J, Buchka S, Blobner M, Borchers F, Fabian M, Loidl V, Marschall U, Morgeli R, Nau C, Otto M, Rombey T, Saller T, Schulz M, Treskatsch S, Busse R, Mansmann U, Schaller SJ; PRAEP-GO consortium and PRAEP-GO investigators. Supervised multimodal prehabilitation of older patients with frailty or prefrailty before elective surgery: a multicentre randomised controlled outcome assessor-blinded trial. Lancet Healthy Longev. 2026 Sep 15:100899. doi: 10.1016/j.lanhl.2026.100899. Online ahead of print.
- Derived from this study: PubMed 42163295Rombey T, Eckhardt H, Quentin W, Weber Z, Buchka S, Kiselev J, Loidl V, Mansmann U, Schaller SJ, Schmidt K, Spies C, Busse R, Schoner L. Cost-effectiveness of prehabilitation for elderly (pre-)frail patients prior to elective surgery compared to standard care - an economic evaluation from a societal perspective. BMC Med. 2026 May 21;24(1):326. doi: 10.1186/s12916-026-04933-6.
- Derived from this study: PubMed 41188708Schone 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.
- Derived from this study: PubMed 38448804Eckhardt 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.
- Derived from this study: PubMed 35668532Schaller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, Prof., MD study chair
Charite University, Berlin, Germany
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation- new form of care in people with Frailty and Frail Elderly, run by Charite University, Berlin, Germany at 23 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of care dependency (time frame: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04418271, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.