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

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

The patients included in PRÄP-GO and the corresponding comparison cohorts will be offered to participate in this complementary study in order to be able to carry out a detailed characterization and phenotyping of the frailty complex.

Amendment vote of 08/05/2024: Recruitment extension of Non-frail surgical control group (NFC cohort) until August 31, 2025.

As part of the innovation fund project PRÄP-GO (EA1/225/19), a multimodal intervention is being conducted in patients with a frailty syndrome. However, the health care research project is limited to evaluating clinical issues only. In order to be able to research further pathophysiological, clinical, psychosocial and work-organizational connections, different groups of participants will be offered the participation in this scientific support program of PRÄP-GO.

The groups of participants in this accompanying program ANA-PRÄP-GO are:

• Randomized study patients with a frailty syndrome of the intervention study PRÄP-GO (PG cohort)
• Non-frail surgical control group (NFC cohort)
• Non-surgical comparison group (NO cohort)
• Participants with health professions (GB cohort)

Additionally, relatives of the patients can be included.

Subprojects are included to reflect research questions of interest in sub groups:

• Success of endoprosthetic implants (clinical outcome and gait pattern after total hip arthroplasty and total knee arthroplasty in frail patients)
• Functional treatment outcome and health-related quality of life after elective spinal surgery in the PG cohort, in the NFC cohort, and in the NO cohort
• Hemodynamic evaluation in patients of the PG and NFC cohort with preoperative abnormal cardiovascular function
• Establishment of a German standard database for 14 CANTAB tests by CANTAB Connect technology
• Aggregated evaluation of the cognitive data of different surgical cohorts from studies carried out at the department of anesthesiology to describe domain-specific changes in the perioperative course
• Perspectives of different health professional groups regarding barriers and facilitators in the implementation of a prehabilitation program and necessary changes in skill, organizational and management, and communication in an interdisciplinary setting
• Perspectives of patients and significant others regarding the organizational pathway of the prehabilitation program
• Frequency, pathophysiology and trajectory of muscle weakness as well as functional impairments of patients admitted to intensive care units of the PG and NFC cohort and their long-term outcomes.
• The gut microbiome as a potential risk factor for perioperative neurocognitive disorders (PNDs) in the elderly
• Evaluation of nutrition data in all cohorts (e.g. adherence to mediterranean diet, nutrition habits, nutritional status, dental status etc.)

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