Cardiac ComplicationNCT05114408
Trimodal Prehabilitation in Patients Undergoing Elective Surgery
A study testing 4 week trimodal prehabilitation course in people with Cardiac Complication and Perioperative Complication, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Patients scheduled for elective surgery will undergo 4 week course of trimodal prehabilitation Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiac Complication, Perioperative Complication
- What is being tested?
- 4 week trimodal prehabilitation course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 7 Jun 2012to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 70 and/or American Society of American Society of Anesthesiologists Physical Status Classification System (ASA) 3-4
- Unfit patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mateusz Kreczko, MD contact
Poland1 site, 1 recruiting
- Recruiting
University Clinical Center in Gdansk - Departament of Anesthesiolog and Intensive cCre
Gdansk, 80-214
Tomasz Jasinski, MD, tjasinski@uck.gda.pl
Radoslaw Owczuk, Ph.D.
About this study
Official title: The Influence of Prehabilitation on the Surgical Patients Condition
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.
- Conditions
- Cardiac Complication, Perioperative Complication
- Being tested
- 4 week trimodal prehabilitation course
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 week trimodal prehabilitation courseOther
trimodal prehabilitation in mixed: stationary and "at-home" structure
| Study group | Role | What they receive |
|---|---|---|
| Trimodal prehabilitation | Experimental | Patients qualified for elective surgery that meet criteria for prehabilitation Receives: Other: 4 week trimodal prehabilitation course |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
change in aerobic capacity
Measured: baseline and pre surgery
Yale Physical Activity Survey (YPAS)
change in physical activity
Measured: 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)
Measured: 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:
- minimal value (moderate malnutrition)
- max value (severe malnutrition)
Measured: 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
Measured: baseline and pre surgery
motivation questionaire (MQ)
change in patient's motivation
0-10 0 - low motiwation 10 max motivation
Measured: baseline and pre surgery
Perceives stress - Perceived Stress Questionaire (PSS)
stress level - 0 - min value - no perceived stress 20 - maximal preceived stress
Measured: baseline and pre surgery
Secondary outcomes (5)
Number of Participants requiring reintervention during initial hospitalization
Measured: 3 months after surgery
ICU length of stay
Measured: 3 months after surgery
Total hospital length of stay
Measured: 3 months after surgery
Number of Patients requiring Emergency room visits and hospital readmissions
Measured: at 30 days
Number of Patients with postoperative complications
number and severity
Measured: 3 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start7 Jun 2012
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ComplicationStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Collaborators
- University Clinical Centre, Gdansk, EIT Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114408
- Sponsor's protocol ID
- PREHAB1
- Status last verified
- Nov 2021
- First submitted
- 14 Jul 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Prehabilitation on the Surgical Patients Condition
- ClinicalTrials.gov ID
- NCT05114408
- Acronym / sponsor ID
- PREHAB1
- Conditions
- Cardiac Complication, Perioperative Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Collaborators
- University Clinical Centre, Gdansk, EIT Health
- Study start
- 7 Jun 2012 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients scheduled for elective surgery will undergo 4 week course of trimodal prehabilitation
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trimodal prehabilitation | Experimental | Other: 4 week trimodal prehabilitation coursePatients qualified for elective surgery that meet criteria for prehabilitation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 70 and/or American Society of American Society of Anesthesiologists Physical Status Classification System (ASA) 3-4
- Unfit patients
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4 week trimodal prehabilitation coursetrimodal prehabilitation in mixed: stationary and "at-home" structure | Other | Trimodal prehabilitation |
Primary outcome
6 minute walk test
Time frame: baseline and pre surgery
change in aerobic capacity
Yale Physical Activity Survey (YPAS)
Time frame: baseline and pre surgery
change in physical activity
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)
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)
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
motivation questionaire (MQ)
Time frame: baseline and pre surgery
change in patient's motivation 0-10 0 - low motiwation 10 max motivation
Perceives stress - Perceived Stress Questionaire (PSS)
Time frame: baseline and pre surgery
stress level - 0 - min value - no perceived stress 20 - maximal preceived stress
5 secondary outcomes
Number of Participants requiring reintervention during initial hospitalization
Time frame: 3 months after surgery
ICU length of stay
Time frame: 3 months after surgery
Total hospital length of stay
Time frame: 3 months after surgery
Number of Patients requiring Emergency room visits and hospital readmissions
Time frame: at 30 days
Number of Patients with postoperative complications
Time frame: 3 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mateusz Kreczko, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 week trimodal prehabilitation course in people with Cardiac Complication and Perioperative Complication, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomasz Jasiński, MD PhD (+48583493280, tjasinski@uck.gda.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walk test (time frame: baseline and pre surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.