Trimodal Prehabilitation in Patients Undergoing Elective Surgery

November 4, 2021 updated by: Medical University of Gdansk

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:
        • Principal Investigator:
          • Radoslaw Owczuk, Ph.D.
        • Principal Investigator:
          • Tomasz Jasinski, Ph.D.
        • Sub-Investigator:
          • Mateusz Kreczko, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6 minute walk test
Time Frame: baseline and pre surgery
change in aerobic capacity
baseline and pre surgery
Yale Physical Activity Survey (YPAS)
Time Frame: baseline and pre surgery
change in physical activity
baseline and pre surgery
self-perceived health status scale (36-Item Short Form Survey - SF36)
Time Frame: baseline and pre surgery
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
Time Frame: baseline and pre surgery

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
Time Frame: 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
baseline and pre surgery
motivation questionaire (MQ)
Time Frame: baseline and pre surgery

change in patient's motivation

0-10 0 - low motiwation 10 max motivation
baseline and pre surgery
Perceives stress - Perceived Stress Questionaire (PSS)
Time Frame: baseline and pre surgery
stress level - 0 - min value - no perceived stress 20 - maximal preceived stress
baseline and pre surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants requiring reintervention during initial hospitalization
Time Frame: 3 months after surgery
3 months after surgery
ICU length of stay
Time Frame: 3 months after surgery
3 months after surgery
Total hospital length of stay
Time Frame: 3 months after surgery
3 months after surgery
Number of Patients requiring Emergency room visits and hospital readmissions
Time Frame: at 30 days
at 30 days
Number of Patients with postoperative complications
Time Frame: 3 month after surgery
number and severity
3 month after surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient concentration questionaire (P3CQ)
Time Frame: after prehabilitation course

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)
Time Frame: after recruitment
Staff engagement
after recruitment
cost analysis
Time Frame: 3 months after surgery
3 months after surgery
Continuity of Care Questionaire (NCQ)
Time Frame: after prehabilitation course
form 0 - 5 pints 0 - lack of continuity of care 5 - maximal continuitu of care
after prehabilitation course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Gdansk

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Clinical Centre, Gdansk
EIT Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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