CClinicalTrials.gg
Status unknownNCT05114408Updated Nov 10, 2021

Trimodal Prehabilitation in Patients Undergoing Elective Surgery

An interventional study of 4 week trimodal prehabilitation course in Cardiac Complication and Perioperative Complication, sponsored by Medical University of Gdansk. Status unknown at 1 site in Poland. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-11-10.

Sponsored by Medical University of Gdansk · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 9 years 1 month after the study started (first participant enrolled Jun 2012, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cardiac Complication
  • Perioperative Complication
03

In context

Lead sponsor

Medical University of Gdansk is the lead sponsor of 130 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Trimodal prehabilitation

    Patients qualified for elective surgery that meet criteria for prehabilitation

    Other: 4 week trimodal prehabilitation course

Interventions

  • Other4 week trimodal prehabilitation course

    trimodal prehabilitation in mixed: stationary and "at-home" structure

06

What researchers measure

Primary outcomes

  1. 6 minute walk test

    change in aerobic capacity

    Time frame: baseline and pre surgery

  2. Yale Physical Activity Survey (YPAS)

    change in physical activity

    Time frame: baseline and pre surgery

  3. 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)

    Time frame: baseline and pre surgery

  4. 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: 1. minimal value (moderate malnutrition) 2. max value (severe malnutrition)

    Time frame: baseline and pre surgery

  5. 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

    Time frame: baseline and pre surgery

  6. motivation questionaire (MQ)

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

    Time frame: baseline and pre surgery

  7. Perceives stress - Perceived Stress Questionaire (PSS)

    stress level - 0 - min value - no perceived stress 20 - maximal preceived stress

    Time frame: baseline and pre surgery

Secondary outcomes

  1. Number of Participants requiring reintervention during initial hospitalization

    Time frame: 3 months after surgery

  2. ICU length of stay

    Time frame: 3 months after surgery

  3. Total hospital length of stay

    Time frame: 3 months after surgery

  4. Number of Patients requiring Emergency room visits and hospital readmissions

    Time frame: at 30 days

  5. Number of Patients with postoperative complications

    number and severity

    Time frame: 3 month after surgery

Other outcomes

  1. Patient concentration questionaire (P3CQ)

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

    Time frame: after prehabilitation course

  2. Staff engagement questionaire (ACT)

    Staff engagement

    Time frame: after recruitment

  3. cost analysis

    Time frame: 3 months after surgery

  4. Continuity of Care Questionaire (NCQ)

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

    Time frame: after prehabilitation course

07

Study locations

1 of 1 sites recruiting
  • University Clinical Center in Gdansk - Departament of Anesthesiolog and Intensive cCre
    Gdansk, 80-214, Poland
    • Tomasz Jasinski, MD · Contact · tjasinski@uck.gda.pl
    • Radoslaw Owczuk, Ph.D. · Principal investigator
    • Tomasz Jasinski, Ph.D. · Principal investigator
    • Mateusz Kreczko, MD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05114408
Lead sponsor
Medical University of Gdansk
Collaborators
University Clinical Centre, Gdansk, EIT Health
Responsible party
Sponsor
First posted
Nov 10, 2021
Start date
Jun 7, 2012
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Nov 10, 2021

Study contacts

Tomasz Jasiński, MD PhD
Contact
tjasinski@uck.gda.pl
+48583493280
Mateusz Kreczko, MD
Contact
+48583493280

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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