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

Frailty Syndrome Clinical Trial

Official title: 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)

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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.) ;

Related Conditions & MeSH terms

• Frailty
• Frailty Syndrome
• Syndrome

• NCT number: NCT04880824
• Study type: Observational
• Source: Charite University, Berlin, Germany
• Contact: Claudia Spies, MD, Prof.
• Phone: +49 30 450 551102
• Email: claudia.spies@charite.de
• Status: Recruiting
• Start date: May 19, 2021
• Completion date: August 31, 2025