Clinical trial NCT04418271: Prehabilitation of Elderly Patients With Frailty Syndrome Before Elective Surgery (PRAEP-GO)
Official title: Prehabilitation of Elderly Frail or Pre-frail Patients Prior to Elective Surgery - a Randomized Controlled Multicenter Study (PRAEP-Go)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Frail Elderly
Keywords: Prehabilitation, Physiotherapy, Exercise Therapy, Rehabilitation, Nutritional Intervention, Multidisciplinary Intervention, Frailty, Surgery
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich, The Institute for Medical Information Processing, Biometry, and Epidemiology
name: Technische Universität Berlin
name: BARMER
First posted: 2020-06-05
Enrollment: 1199
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility 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)

Primary outcomes:
measure: Degree of care dependency
timeFrame: Up to one year
Secondary outcomes:
measure: Barthel Index
timeFrame: Up to one year
measure: Change in NBA score
timeFrame: Up to one year
measure: NBA domain change
timeFrame: Up to one year
measure: Surrogate for Neurocognitive Disorder (NCD)
timeFrame: Up to one year
measure: Screening tool for cognitive vulnerability
timeFrame: Up to one year
measure: Dementia risk assessed by MOCA
timeFrame: Up to one year
measure: Delirium
timeFrame: Up to one year
measure: Frailty
timeFrame: Up to one year
measure: Perioperative complications by Clavien-Dindo
timeFrame: Up to hospital discharge
measure: Every mobility
timeFrame: Up to one year
measure: Autonomy Preference
timeFrame: At the beginning of the observation
measure: Extent of involvement in shared decision-making process
timeFrame: At the beginning of the observation
measure: Arm circumference
timeFrame: Up to one year
measure: Calf circumference
timeFrame: Up to one year
measure: Nutritional Status
timeFrame: Up to one year
measure: Change in body weight
timeFrame: Up to one year
measure: Instrumental Activities of daily living (IADL)
timeFrame: Up to one year
measure: Functional endurance
timeFrame: Up to one year
measure: Function of the respiratory system
timeFrame: Up to one year
measure: Depression
timeFrame: Up to one year
measure: Anxiety
timeFrame: Up to one year
measure: Health related quality of life
timeFrame: Up to one year
measure: Disability by WHODAS 2.0
timeFrame: Up to one year
measure: Falls
timeFrame: Up to one year
measure: Fear of Falling
timeFrame: Up to one year
measure: Satisfaction with the intervention: ZUF-8
timeFrame: Up to one year
measure: Mortality
timeFrame: Up to one year
measure: Muscle strength
timeFrame: Up to one year
measure: Functional mobility
timeFrame: Up to one year
measure: Stair climbing speed
timeFrame: Up to one year
measure: Timed Up & Go Test (TUG
timeFrame: Up to one year
measure: Postoperative functional mobility
timeFrame: Up to one year
measure: Length of stay Intensive Care Unit
timeFrame: Participants are followed up for the duration of rehabilitation, an expected average of 1 day]
measure: Admission Intensive Care Unit (ICU) Admission rate on Intensive Care Unit (ICU)
timeFrame: Participants are followed up for the duration of rehabilitation, an expected average of 1 day]
measure: Duration of hospital stay
timeFrame: Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
Other outcomes:
measure: Adverse Discharge Disposition
timeFrame: Participants are followed up after hospital discharge for 1 day
measure: Necessity for follow-up treatment and rehabilitation
timeFrame: Up to one year
measure: Count of new discharge diagnoses
timeFrame: Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
measure: Count of new discharge medication
timeFrame: Participants are followed up for the duration of rehabilitation, an expected average of 7 days]
measure: Duration of rehabilitation
timeFrame: Participants are followed up for the duration of rehabilitation, an expected average of 25 days]
measure: Health economic benefit
timeFrame: Up to one year
measure: Exercise adherence and planned prehabilitation composition
timeFrame: Up to one year
measure: Patient support
timeFrame: Up to one year
measure: Polypharmacy
timeFrame: Up to one year
measure: Alcohol Use
timeFrame: Up to one year
measure: Tobacco Use
timeFrame: Up to one year
measure: Sarcopenia
timeFrame: Up to one year
measure: Social situation measurement 1
timeFrame: Up to one year
measure: Social situation measurement 2
timeFrame: Up to one year
measure: Pain: Numeric rating scale
timeFrame: Up to one year
measure: Loneliness
timeFrame: Up to one year
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabetes Zentrum
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine (CBF), Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Auguste-Viktoria-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
city: Berlin
country: Germany
facility: Bundeswehrkrankenhaus
city: Berlin
country: Germany
facility: CARITAS Klinik Maria Heimsuchung
city: Berlin
country: Germany
facility: Dominikus-Krankenhaus
city: Berlin
country: Germany
facility: Evangelisches Krankenhaus Hubertus
city: Berlin
country: Germany
facility: Humboldt-Klinikum - Vivantes - Netzwerk für Gesundheit GmbH
city: Berlin
country: Germany
facility: Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH
city: Berlin
country: Germany
facility: Martin-Luther-Krankenhaus
city: Berlin
country: Germany
facility: Sankt Joseph Krankenhaus
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Frankfurt/Oder
country: Germany
facility: Klinikum Frankfurt Oder GmbH
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Kremmen
country: Germany
facility: Sana Kliniken Sommerfeld
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Universität zu Lübeck
city: München
country: Germany
facility: Klinikum der Universität München, LMU Campus Großhadern
city: München
country: Germany
facility: Klinikum rechts der Isar - Technische Universität München
city: München
country: Germany
facility: München Klinik Bogenhausen
city: Nauen
country: Germany
facility: Havelland Kliniken GmbH - Klinik Nauen
city: Rathenow
country: Germany
facility: Havelland Kliniken-Klinik Rathenow
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, Prof., MD
role: STUDY_CHAIR
References:
citation: Schaller 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.