Trimodal Prehabilitation in Patients Undergoing Elective Surgery

Perioperative Complication Clinical Trial

Official title:

The Influence of Prehabilitation on the Surgical Patients Condition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05114408
• Other study ID #: PREHAB1
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2012
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2021
• Source: Medical University of Gdansk
• Contact: Tomasz Jasinski, MD PhD
• Phone: +48583493280
• Email: tjasinski[@]uck.gda.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Complication
• Perioperative Complication

Intervention

Other:
• 4 week trimodal prehabilitation course
trimodal prehabilitation in mixed: stationary and "at-home" structure

Locations

Country	Name	City	State
Poland	University Clinical Center in Gdansk - Departament of Anesthesiolog and Intensive cCre	Gdansk

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Gdansk	EIT Health, University Clinical Centre, Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Staff engagement questionaire (ACT)	Staff engagement	after recruitment
Other	cost analysis		3 months after surgery
Other	Continuity of Care Questionaire (NCQ)	form 0 - 5 pints 0 - lack of continuity of care 5 - maximal continuitu of care	after prehabilitation course
Primary	6 minute walk test	change in aerobic capacity	baseline and pre surgery
Primary	Yale Physical Activity Survey (YPAS)	change in physical activity	baseline and pre surgery
Primary	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
Primary	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
Primary	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
Primary	motivation questionaire (MQ)	change in patient's motivation; 0-10 0 - low motiwation 10 max motivation	baseline and pre surgery
Primary	Perceives stress - Perceived Stress Questionaire (PSS)	stress level - 0 - min value - no perceived stress 20 - maximal preceived stress	baseline and pre surgery
Secondary	Number of Participants requiring reintervention during initial hospitalization		3 months after surgery
Secondary	ICU length of stay		3 months after surgery
Secondary	Total hospital length of stay		3 months after surgery
Secondary	Number of Patients requiring Emergency room visits and hospital readmissions		at 30 days
Secondary	Number of Patients with postoperative complications	number and severity	3 month after surgery