Trimodal Prehabilitation in Patients Undergoing Elective Surgery

The Influence of Prehabilitation on the Surgical Patients Condition

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

Study Overview

• Status: Recruiting
• Conditions: Cardiac Complication; Perioperative Complication
• Intervention / Treatment: Other: 4 week trimodal prehabilitation course

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tomasz Jasiński, MD PhD; Phone Number: +48583493280; Email: tjasinski@uck.gda.pl
• Study Contact Backup: Name: Mateusz Kreczko, MD; Phone Number: +48583493280

Study Locations

• Poland
  • Gdansk, Poland, 80-214
    • Recruiting
    • University Clinical Center in Gdansk - Departament of Anesthesiolog and Intensive cCre
    • Contact: Tomasz Jasinski, MD; Email: tjasinski@uck.gda.pl
    • Principal Investigator: Radoslaw Owczuk, Ph.D.
    • Principal Investigator: Tomasz Jasinski, Ph.D.
    • Sub-Investigator: Mateusz Kreczko, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trimodal prehabilitation; Patients qualified for elective surgery that meet criteria for prehabilitation	Other: 4 week trimodal prehabilitation course; trimodal prehabilitation in mixed: stationary and "at-home" structure

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	number and severity	3 month after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient concentration questionaire (P3CQ)	Patient experience: 0 - worst (medical staff not concentrated on patient) 19 - best experience (full concentration on patients needs)	after prehabilitation course
Staff engagement questionaire (ACT)	Staff engagement	after recruitment
cost analysis		3 months after surgery
Continuity of Care Questionaire (NCQ)	form 0 - 5 pints 0 - lack of continuity of care 5 - maximal continuitu of care	after prehabilitation course

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Collaborators: University Clinical Centre, Gdansk; EIT Health

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2012
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 4, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PREHAB1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No