Prehabilitation of Elderly Patients With Frailty Syndrome Before Elective Surgery (PRAEP-GO)

Charité University Medicine Berlin

Status: Enrolling

Conditions: Frailty; Frail Elderly

Treatments: Behavioral: Prehabilitation- new form of care

Study type: Interventional

Funder types: Other

Identifiers

NCT04418271

U1111-1253-4820 (Other Identifier)

PRAEP-GO

Details and patient eligibility

About

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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,400 participants in 2 patient groups

Prehabilitation

Experimental group

Description:

Prefrail and frail patients receive prehabilitation (new form of care)

Treatment:

Behavioral: Prehabilitation- new form of care

Standard of Care

No Intervention group

Description:

Prefrail and frail patients receive no prehabilitation, but receive standard of care