Coronary Artery DiseaseNCT04401397

Effect of Early Mobilization on Length of Stay, Recovery and Readmission Rate of Patients After CABG or AVR/MVR Surgery

A study testing Intensive early mobilization techniques in people with Coronary Artery Disease and Aortic Valve Disease, run by Dimitris Chatzitheodorou at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease
What is being tested?: Intensive early mobilization techniques
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteGreece
Study dates: 3 Jun 2020to 23 Dec 2020
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Elective CABG or AVR or MVR surgery
No previous CABG or valve surgery
Isolated / multivessel CABG

Who cannot join

Current neurological disorders
Previous cerebral vascular accident with residual neurological deficit significant enough to limit exercise
Significant limiting comorbidities that would prevent full participation

Trial locations and contacts

1 site in 1 country.

Greece1 site

Papageorgiou General Hospital
Thessaloniki, Pavlou Mela Municipality, 56403

Other trials in Greece

About this study

Official title: The Effect of Inpatient Intensive Early Mobilisation Intervention on Length of Hospital Stay, Medical and Functional Recovery and Readmission Rate of Patients After CABG or AVR/MVR: A Randomized Single Blind Controlled Clinical Trial.

The present study will investigate the volume and extent of the expected physiological effects of "early mobilization" on the prevention of the clinical illness' detrimental sequelae and on the functional recovery promotion of CABG, AVR and MVR patients. Consequently, it will investigate if the improved health outcomes may limit the number and intensity of complications and thus if it may speed up hospital discharge.

Read the detailed description

Although the effects of "early mobilization" have been studied mainly in the intensive care unit setting, the findings could be applied to the surgical units' patients too, since they share common physiological and clinical characteristics. In the literature the effectiveness of "early mobilization" in the length of hospital stay and recovery of the patients operated for coronary artery bypass graft and heart valve replacement in the cardiac surgery setting, is unknown.

The term "early mobilization" is not restricted to a time factor procedure but contains the provision of a customized dynamic set of physical therapy techniques which in studies are variably determined in terms of duration, intensity, frequency and content.

The aim of the study is to determine the clinical effectiveness of the intensive early mobilization physical therapy intervention compared with standard care of physical therapy in the cardio-thoracic surgery clinic of Papageorgiou General Hospital of Thessaloniki.

The present study will investigate the volume and extend of the expected physiological effects of "early mobilization" on the prevention of the clinical illness' detrimental sequelae and on the functional recovery promotion, hospital mortality and readmission rate of CABG, AVR and MVR patients. Consequently, it will investigate if the improved health outcomes may limit the number and intensity of complications and thus may speed up hospital discharge. In the first group of the experimental design, patients will be treated with an intensive early mobilization protocol and the patients of the second group will receive a standard care physical therapy treatment. Controlling for the detailed baseline characteristics that will be assessed during medical history at admission, potential bias will be limited from unmeasured confounders of the study.

Conditions: Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease
Being tested: Intensive early mobilization techniques
Medical subject headings: Coronary Artery Disease, Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intensive early mobilization techniquesProcedure or surgery
Pulmonary techniques: lung mechanics and breathing pattern restoration, mucus clearance techniques, breathing control and cough techniques.
Musculoskeletal techniques: strengthening and functional exercises, active assistive moving techniques.

Study groups in NCT04401397
Study group	Role	What they receive
Early mobilization group	Experimental	Immediately after ICU extubation, enrolled patients will receive an intensive 30-45 minutes, implemented twice a day early mobilization protocol containing psychological empowerment, detailed informative education of patients and close relatives, close monitoring of the recovery course, frequent parameter protocol configuration, high intensity active progressive pulmonary and musculoskeletal exercises and mobility techniques, close monitoring for early identification and measures for prevention and treatment of complications. Receives: Procedure: Intensive early mobilization techniques
Standard care group	Active comparator	Enrolled patients will receive the standard hospital mobilization protocol after their admission to the ward, containing standardized basic pulmonary and mobilization techniques of 15 minutes, once a day. Receives: Procedure: Intensive early mobilization techniques

What is being measured

The primary outcome is the main question the study is designed to answer.

Length of postoperative hospital stay
The number of postoperative days that the patients stay in the ward after their surgery procedure and ICU discharge.
Measured: Up to 6 weeks
Readmission rate
The number of discharged patients that will be readmitted in the hospital for a condition of their underlying disease in a 30 days period after surgery.
Measured: Up to 6 weeks
Number of complications
The total number of medical events the patients will develop during their postoperative stay in the ward.
Measured: Up to 6 weeks
Severity of complications
Classification of the complications as "minor" or "major" according to the physicians' expert opinion based on published clinical standards.
Measured: Up to 6 weeks
Time to regain hemodynamic stability
The time in days that is required for the patients to be without inotrope or vasodilator drugs and remain normal and stable in arterial blood pressure, heart rate and blood gas rates.
Measured: Up to 6 weeks
Two-minute walk test
The distance in meters that a patient can walk under the specific test conditions, at the day of discharge.
Measured: Up to 6 weeks
Functional recovery
The time in days that is required for the patients to be autonomous in accessing and using the toilet in their ward.
Measured: Up to 6 weeks
High cost medical procedures
The number of high cost medical procedures the patients will undergo during their postoperative stay in the ward.
Measured: Up to 6 weeks

Secondary outcomes (1)

Hospital mortality
The number of postsurgical hospital deaths.
Measured: Up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jun 202023 Dec 2020

First posted26 May 2020
Study start3 Jun 2020
Primary completion10 Dec 2020
Study completion23 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
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: Supportive care
Allocation: Randomised
Intervention model: Factorial
Model description: Prospective randomized controlled double-blind 2-group experimental design.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04401397
Sponsor's protocol ID: PapageorgiouGH
Status last verified: Jan 2021
First submitted: 15 May 2020
Last updated: 5 Jan 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chiarici A, Andrenelli E, Serpilli O, Andreolini M, Tedesco S, Pomponio G, Gallo MM, Martini C, Papa R, Coccia M, Ceravolo MG. An Early Tailored Approach Is the Key to Effective Rehabilitation in the Intensive Care Unit. Arch Phys Med Rehabil. 2019 Aug;100(8):1506-1514. doi: 10.1016/j.apmr.2019.01.015. Epub 2019 Feb 21.
PubMed 30796918
Corcoran JR, Herbsman JM, Bushnik T, Van Lew S, Stolfi A, Parkin K, McKenzie A, Hall GW, Joseph W, Whiteson J, Flanagan SR. Early Rehabilitation in the Medical and Surgical Intensive Care Units for Patients With and Without Mechanical Ventilation: An Interprofessional Performance Improvement Project. PM R. 2017 Feb;9(2):113-119. doi: 10.1016/j.pmrj.2016.06.015. Epub 2016 Jun 23.
PubMed 27346093
Lord RK, Mayhew CR, Korupolu R, Mantheiy EC, Friedman MA, Palmer JB, Needham DM. ICU early physical rehabilitation programs: financial modeling of cost savings. Crit Care Med. 2013 Mar;41(3):717-24. doi: 10.1097/CCM.0b013e3182711de2.
PubMed 23318489
Tsuboi N, Hiratsuka M, Kaneko S, Nishimura N, Nakagawa S, Kasahara M, Kamikubo T. Benefits of Early Mobilization After Pediatric Liver Transplantation. Pediatr Crit Care Med. 2019 Feb;20(2):e91-e97. doi: 10.1097/PCC.0000000000001815.
PubMed 30489487
van Willigen Z, Collings N, Richardson D, Cusack R. Quality improvement: The delivery of true early mobilisation in an intensive care unit. BMJ Qual Improv Rep. 2016 Dec 30;5(1):u211734.w4726. doi: 10.1136/bmjquality.u211734.w4726. eCollection 2016.
PubMed 28090326
Brummel NE, Girard TD, Ely EW, Pandharipande PP, Morandi A, Hughes CG, Graves AJ, Shintani A, Murphy E, Work B, Pun BT, Boehm L, Gill TM, Dittus RS, Jackson JC. Feasibility and safety of early combined cognitive and physical therapy for critically ill medical and surgical patients: the Activity and Cognitive Therapy in ICU (ACT-ICU) trial. Intensive Care Med. 2014 Mar;40(3):370-9. doi: 10.1007/s00134-013-3136-0. Epub 2013 Nov 21.
PubMed 24257969
Li Z, Peng X, Zhu B, Zhang Y, Xi X. Active mobilization for mechanically ventilated patients: a systematic review. Arch Phys Med Rehabil. 2013 Mar;94(3):551-61. doi: 10.1016/j.apmr.2012.10.023. Epub 2012 Nov 2.
PubMed 23127305
Parker A, Sricharoenchai T, Needham DM. Early Rehabilitation in the Intensive Care Unit: Preventing Physical and Mental Health Impairments. Curr Phys Med Rehabil Rep. 2013 Dec;1(4):307-314. doi: 10.1007/s40141-013-0027-9.
PubMed 24436844
Adler J, Malone D. Early mobilization in the intensive care unit: a systematic review. Cardiopulm Phys Ther J. 2012 Mar;23(1):5-13.
PubMed 22807649
Mendez-Tellez PA, Nusr R, Feldman D, Needham DM. Early Physical Rehabilitation in the ICU: A Review for the Neurohospitalist. Neurohospitalist. 2012 Jul;2(3):96-105. doi: 10.1177/1941874412447631.
PubMed 23983871
Morris PE, Griffin L, Berry M, Thompson C, Hite RD, Winkelman C, Hopkins RO, Ross A, Dixon L, Leach S, Haponik E. Receiving early mobility during an intensive care unit admission is a predictor of improved outcomes in acute respiratory failure. Am J Med Sci. 2011 May;341(5):373-7. doi: 10.1097/MAJ.0b013e31820ab4f6.
PubMed 21358312
Needham DM, Korupolu R, Zanni JM, Pradhan P, Colantuoni E, Palmer JB, Brower RG, Fan E. Early physical medicine and rehabilitation for patients with acute respiratory failure: a quality improvement project. Arch Phys Med Rehabil. 2010 Apr;91(4):536-42. doi: 10.1016/j.apmr.2010.01.002.
PubMed 20382284
Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.
PubMed 19446324
Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.
PubMed 18596631
Hopkins RO, Spuhler VJ, Thomsen GE. Transforming ICU culture to facilitate early mobility. Crit Care Clin. 2007 Jan;23(1):81-96. doi: 10.1016/j.ccc.2006.11.004.
PubMed 17307118

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Inpatient Intensive Early Mobilisation Intervention on Length of Hospital Stay, Medical and Functional Recovery and Readmission Rate of Patients After CABG or AVR/MVR: A Randomized Single Blind Controlled Clinical Trial.
ClinicalTrials.gov ID: NCT04401397
Acronym / sponsor ID: PapageorgiouGH
Conditions: Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Dimitris ChatzitheodorouUniversity, hospital or other
Collaborators: University of Macedonia, Thessaloniki, Greece
Study start: 3 Jun 2020 (actual)
Primary completion: 10 Dec 2020 (actual)
Study completion: 23 Dec 2020 (actual)
First posted: 26 May 2020 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Prospective randomized controlled double-blind 2-group experimental design.

Arm	Type	Receives
Early mobilization group	Experimental	Procedure: Intensive early mobilization techniquesImmediately after ICU extubation, enrolled patients will receive an intensive 30-45 minutes, implemented twice a day early mobilization protocol containing psychological empowerment, detailed informative education of patients and close relatives, close monitoring of the recovery course, frequent parameter protocol configuration, high intensity active progressive pulmonary and musculoskeletal exercises and mobility techniques, close monitoring for early identification and measures for prevention and treatment of complications.
Standard care group	Active comparator	Procedure: Intensive early mobilization techniquesEnrolled patients will receive the standard hospital mobilization protocol after their admission to the ward, containing standardized basic pulmonary and mobilization techniques of 15 minutes, once a day.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Elective CABG or AVR or MVR surgery
No previous CABG or valve surgery
Isolated / multivessel CABG

Key exclusion criteria (3 listed)

Current neurological disorders
Previous cerebral vascular accident with residual neurological deficit significant enough to limit exercise
Significant limiting comorbidities that would prevent full participation

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
Intensive early mobilization techniquesPulmonary techniques: lung mechanics and breathing pattern restoration, mucus clearance techniques, breathing control and cough techniques. Musculoskeletal techniques: strengthening and functional exercises, active assistive moving techniques.	Procedure or surgery	Early mobilization group, Standard care group

Primary outcome

Length of postoperative hospital stay
Time frame: Up to 6 weeks
The number of postoperative days that the patients stay in the ward after their surgery procedure and ICU discharge.
Readmission rate
Time frame: Up to 6 weeks
The number of discharged patients that will be readmitted in the hospital for a condition of their underlying disease in a 30 days period after surgery.
Number of complications
Time frame: Up to 6 weeks
The total number of medical events the patients will develop during their postoperative stay in the ward.
Severity of complications
Time frame: Up to 6 weeks
Classification of the complications as "minor" or "major" according to the physicians' expert opinion based on published clinical standards.
Time to regain hemodynamic stability
Time frame: Up to 6 weeks
The time in days that is required for the patients to be without inotrope or vasodilator drugs and remain normal and stable in arterial blood pressure, heart rate and blood gas rates.
Two-minute walk test
Time frame: Up to 6 weeks
The distance in meters that a patient can walk under the specific test conditions, at the day of discharge.
Functional recovery
Time frame: Up to 6 weeks
The time in days that is required for the patients to be autonomous in accessing and using the toilet in their ward.
High cost medical procedures
Time frame: Up to 6 weeks
The number of high cost medical procedures the patients will undergo during their postoperative stay in the ward.

1 secondary outcome

Hospital mortality
Time frame: Up to 6 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
Background: PubMed 30796918Chiarici A, Andrenelli E, Serpilli O, Andreolini M, Tedesco S, Pomponio G, Gallo MM, Martini C, Papa R, Coccia M, Ceravolo MG. An Early Tailored Approach Is the Key to Effective Rehabilitation in the Intensive Care Unit. Arch Phys Med Rehabil. 2019 Aug;100(8):1506-1514. doi: 10.1016/j.apmr.2019.01.015. Epub 2019 Feb 21.
Background: PubMed 27346093Corcoran JR, Herbsman JM, Bushnik T, Van Lew S, Stolfi A, Parkin K, McKenzie A, Hall GW, Joseph W, Whiteson J, Flanagan SR. Early Rehabilitation in the Medical and Surgical Intensive Care Units for Patients With and Without Mechanical Ventilation: An Interprofessional Performance Improvement Project. PM R. 2017 Feb;9(2):113-119. doi: 10.1016/j.pmrj.2016.06.015. Epub 2016 Jun 23.
Background: PubMed 23318489Lord RK, Mayhew CR, Korupolu R, Mantheiy EC, Friedman MA, Palmer JB, Needham DM. ICU early physical rehabilitation programs: financial modeling of cost savings. Crit Care Med. 2013 Mar;41(3):717-24. doi: 10.1097/CCM.0b013e3182711de2.
Background: PubMed 30489487Tsuboi N, Hiratsuka M, Kaneko S, Nishimura N, Nakagawa S, Kasahara M, Kamikubo T. Benefits of Early Mobilization After Pediatric Liver Transplantation. Pediatr Crit Care Med. 2019 Feb;20(2):e91-e97. doi: 10.1097/PCC.0000000000001815.
Background: PubMed 28090326van Willigen Z, Collings N, Richardson D, Cusack R. Quality improvement: The delivery of true early mobilisation in an intensive care unit. BMJ Qual Improv Rep. 2016 Dec 30;5(1):u211734.w4726. doi: 10.1136/bmjquality.u211734.w4726. eCollection 2016.
Background: PubMed 24257969Brummel NE, Girard TD, Ely EW, Pandharipande PP, Morandi A, Hughes CG, Graves AJ, Shintani A, Murphy E, Work B, Pun BT, Boehm L, Gill TM, Dittus RS, Jackson JC. Feasibility and safety of early combined cognitive and physical therapy for critically ill medical and surgical patients: the Activity and Cognitive Therapy in ICU (ACT-ICU) trial. Intensive Care Med. 2014 Mar;40(3):370-9. doi: 10.1007/s00134-013-3136-0. Epub 2013 Nov 21.
Background: PubMed 23127305Li Z, Peng X, Zhu B, Zhang Y, Xi X. Active mobilization for mechanically ventilated patients: a systematic review. Arch Phys Med Rehabil. 2013 Mar;94(3):551-61. doi: 10.1016/j.apmr.2012.10.023. Epub 2012 Nov 2.
Background: PubMed 24436844Parker A, Sricharoenchai T, Needham DM. Early Rehabilitation in the Intensive Care Unit: Preventing Physical and Mental Health Impairments. Curr Phys Med Rehabil Rep. 2013 Dec;1(4):307-314. doi: 10.1007/s40141-013-0027-9.
Background: PubMed 22807649Adler J, Malone D. Early mobilization in the intensive care unit: a systematic review. Cardiopulm Phys Ther J. 2012 Mar;23(1):5-13.
Background: PubMed 23983871Mendez-Tellez PA, Nusr R, Feldman D, Needham DM. Early Physical Rehabilitation in the ICU: A Review for the Neurohospitalist. Neurohospitalist. 2012 Jul;2(3):96-105. doi: 10.1177/1941874412447631.
Background: PubMed 21358312Morris PE, Griffin L, Berry M, Thompson C, Hite RD, Winkelman C, Hopkins RO, Ross A, Dixon L, Leach S, Haponik E. Receiving early mobility during an intensive care unit admission is a predictor of improved outcomes in acute respiratory failure. Am J Med Sci. 2011 May;341(5):373-7. doi: 10.1097/MAJ.0b013e31820ab4f6.
Background: PubMed 20382284Needham DM, Korupolu R, Zanni JM, Pradhan P, Colantuoni E, Palmer JB, Brower RG, Fan E. Early physical medicine and rehabilitation for patients with acute respiratory failure: a quality improvement project. Arch Phys Med Rehabil. 2010 Apr;91(4):536-42. doi: 10.1016/j.apmr.2010.01.002.
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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intensive early mobilization techniques in people with Coronary Artery Disease and Aortic Valve Disease, run by Dimitris Chatzitheodorou at 1 site in Greece.

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 3 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: finished, as of the sponsor's last update on 5 Jan 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 Greece. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of postoperative hospital stay (time frame: Up to 6 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04401397, which also lists 17 linked publications.

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 5 Jan 2021.