Analysis of Frailty Syndrome Within the Framework of the Innovation Fund Project PRÄP-GO (ANA-PRÄP-GO)

Plain-language summary

This study examines frailty syndrome and a new form of care called prehabilitation (preparation before surgery) in older patients scheduled for surgery. It enrolled several groups, including patients in the PRÄP-GO project and people aged 70 and older scheduled for elective surgery. It was a non-phased study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Charite University, Berlin, Germany

Intervention

Prehabilitation- new form of care

Start date

5/19/2021

Estimated completion

3/21/2025

Countries

Germany

Related genes

Locations

• Schwante, Germany
• Berlin, Germany
• Berlin, Germany
• Berlin, Germany
• Berlin, Germany
• Berlin, Germany
• Berlin, Germany
• Berlin, Germany
• Berlin, Germany
• Berlin, Germany
• Berlin, Germany
• Berlin, Germany
• Berlin, Germany
• Berlin, Germany
• Berlin, Germany
• Berlin, Germany
• Berlin, Germany
• Cottbus, Germany
• Eberswalde, Germany
• Frankfurt (Oder), Germany
• Hamburg, Germany
• Harburg, Germany
• Kremmen, Germany
• Lübeck, Germany
• München, Germany
• München, Germany
• München, Germany

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

PG cohort:

Inclusion criteria

* Consent given and inclusion in PRÄP-GO
* Patient capable of giving consent or existing legal guardian in the case of patients not capable of giving consent

Exclusion criteria

\- None

NFC cohort:

Inclusion criteria

* Patient capable of giving consent or existing legal guardian in the case of patients not capable of giving consent
* Age ≥ 70 years
* Elective surgery planned
* Expected anesthesia duration\> 60 min
* No frailty syndrome (0 positive out of 5 standardized parameters) according to the physical frailty phenotype (Fried et al., 2001)

Exclusion criteria

* Severe cardiac or pulmonary disease (NYHA IV, Gold IV)
* Intracranial interventions
* Moribund patients (palliative situation)
* Patients with a neuropsychiatric clinical picture or severe hearing and / or visual acuity impairment (not compensated by visual or hearing aids), which limit the performance of the neurocognitive tests
* Insufficient language skills
* Participation in another interventional rehabilitation study or a study according to the German Drug Law or the medical Device Law that has not been approved by the study leader (Exception: parallel participation in adjuvant therapy study).

NO cohort:

Inclusion criteria

\- Age ≥ 70 years

* No elective surgery planned
* No surgery within 6 months prior to study enrollment

Exclusion criteria - See NFC cohort

GB cohort:

Inclusion criterion

\- Doctor, nurse or therapist from the cooperation partners of PRAEP-GO who were involved in the project

Exclusion criterion

\- Language barrier

Relatives:

Inclusion criteria

* Member of a patient in the PRÄP-GO cohort
* Age ≥ 18 years

Exclusion criterion

\- Language barrier