Trimodal Prehabilitation in Patients Undergoing Elective Surgery

• Sponsor: Medical University of Gdansk (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05114408
• Collaborator: University Clinical Centre, Gdansk (Other), EIT Health (Other)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 114.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiac Complication; Perioperative Complication	Other: 4 week trimodal prehabilitation course	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Influence of Prehabilitation on the Surgical Patients Condition
• Actual Study Start Date: Jun 7, 2012
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 6 minute walk test [baseline and pre surgery]

   change in aerobic capacity

2. Yale Physical Activity Survey (YPAS) [baseline and pre surgery]

   change in physical activity

3. 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)

4. 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: minimal value (moderate malnutrition) max value (severe malnutrition)

5. 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

6. motivation questionaire (MQ) [baseline and pre surgery]

   change in patient's motivation 0-10 0 - low motiwation 10 max motivation

7. 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

1. Number of Participants requiring reintervention during initial hospitalization [3 months after surgery]

2. ICU length of stay [3 months after surgery]

3. Total hospital length of stay [3 months after surgery]

4. Number of Patients requiring Emergency room visits and hospital readmissions [at 30 days]

5. Number of Patients with postoperative complications [3 month after surgery]

   number and severity

Other Outcome Measures

1. Patient concentration questionaire (P3CQ) [after prehabilitation course]

   Patient experience: 0 - worst (medical staff not concentrated on patient) 19 - best experience (full concentration on patients needs)

2. Staff engagement questionaire (ACT) [after recruitment]

   Staff engagement

3. cost analysis [3 months after surgery]

4. Continuity of Care Questionaire (NCQ) [after prehabilitation course]

   form 0 - 5 pints 0 - lack of continuity of care 5 - maximal continuitu of care

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Clinical Center in Gdansk - Departament of Anesthesiolog and Intensive cCre	Gdansk		Poland	80-214

Sponsors and Collaborators

• Medical University of Gdansk
• University Clinical Centre, Gdansk
• EIT Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of Gdansk
• ClinicalTrials.gov Identifier: NCT05114408
• Other Study ID Numbers: PREHAB1
• First Posted: Nov 10, 2021
• Last Update Posted: Nov 10, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 10, 2021