NCT05114408

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2012

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 10, 2021

Status Verified

November 1, 2021

Enrollment Period

9.6 years

First QC Date

July 14, 2021

Last Update Submit

November 4, 2021

Conditions

Cardiac ComplicationPerioperative Complication

Outcome Measures

Primary Outcomes (7)

  • 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: 1. minimal value (moderate malnutrition) 2. 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 Outcomes (5)

  • 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

Other Outcomes (4)

  • Patient concentration questionaire (P3CQ)

    after prehabilitation course

  • Staff engagement questionaire (ACT)

    after recruitment

  • cost analysis

    3 months after surgery

  • +1 more other outcomes

Study Arms (1)

Trimodal prehabilitation

EXPERIMENTAL

Patients qualified for elective surgery that meet criteria for prehabilitation

Other: 4 week trimodal prehabilitation course

Interventions

4 week trimodal prehabilitation courseOTHER

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

Trimodal prehabilitation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinical Center in Gdansk - Departament of Anesthesiolog and Intensive cCre

Gdansk, 80-214, Poland

RECRUITING

Central Study Contacts

Tomasz Jasiński, MD PhD

CONTACT

+48583493280tjasinski@uck.gda.pl

Mateusz Kreczko, MD

CONTACT

+48583493280

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2021

First Posted

November 10, 2021

Study Start

June 7, 2012

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 10, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)