Trimodal Prehabilitation in Patients Undergoing Elective Surgery

Not Applicable

• Conditions: Cardiac Complication; Perioperative Complication
• Interventions: Other: 4 week trimodal prehabilitation course

• Registration Number: NCT05114408
• Lead Sponsor: Medical University of Gdansk

Brief Summary

Patients scheduled for elective surgery will undergo 4 week course of trimodal prehabilitation

Detailed Description

Patients with high surgical risk will participate in 4 week prehabilitation that will consist of 4 stationary sessions - one per week - comprised of: physiotherapy session, psychological session and nutritional advice. During first session each patient will receive an activity monitor and dedicated mobile app that will record his daily performance.

Study Timeline

• Study Start: 2012-06-07
• Study First Submitted: 2021-07-14
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-04
• Last Update Submitted: 2021-11-04
• Study First Posted: 2021-11-10
• Last Update Posted: 2021-11-10
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age > 70 and/or American Society of American Society of Anesthesiologists Physical Status Classification System (ASA) 3-4
• Unfit patients

Exclusion Criteria

• physical condition that makes the patient is not able to perform rehabilitation exercises
• cardiac and respiratory instability or high risk of its occurrence
• inability to use electronic devices used in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trimodal prehabilitation	4 week trimodal prehabilitation course	Patients qualified for elective surgery that meet criteria for prehabilitation

Primary Outcome Measures

Name	Time	Method
6 minute walk test	baseline and pre surgery	change in aerobic capacity
Yale Physical Activity Survey (YPAS)	baseline and pre surgery	change in physical activity
self-perceived health status scale (36-Item Short Form Survey - SF36)	baseline and pre surgery	change in self-perceived health status (0 - min, 100 - max self perceived health score)
Global Leadership Initiative on Malnutrition (GLIM) scale	baseline and pre surgery	change in nutritional status - malnutrition diagnosed if one phenotypical and one etiological criteria are fulfilled; Severity based on phenotypic criteria: 1. minimal value (moderate malnutrition); 2. max value (severe malnutrition)
Hospital Anxiety and Depression (HAD) scale	baseline and pre surgery	change in psychological status: depression and anxiety criteria 0 points min score - low level od depression and anxiety 21 max score
motivation questionaire (MQ)	baseline and pre surgery	change in patient's motivation; 0-10 0 - low motiwation 10 max motivation
Perceives stress - Perceived Stress Questionaire (PSS)	baseline and pre surgery	stress level - 0 - min value - no perceived stress 20 - maximal preceived stress

Secondary Outcome Measures

Name	Time	Method
Number of Participants requiring reintervention during initial hospitalization	3 months after surgery
ICU length of stay	3 months after surgery
Total hospital length of stay	3 months after surgery
Number of Patients requiring Emergency room visits and hospital readmissions	at 30 days
Number of Patients with postoperative complications	3 month after surgery	number and severity

Trial Locations

Locations (1)

University Clinical Center in Gdansk - Departament of Anesthesiolog and Intensive cCre; 🇵🇱 Gdansk, Poland