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Completed

NCT Number: NCT04401397

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Papageorgiou General Hospital

Thessaloniki, Pavlou Mela Municipality, 56403, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Intensive early mobilization techniques

Procedure

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. Hospital mortality

    Time frame: Up to 6 weeks

    The number of postsurgical hospital deaths.

Sponsors and collaborators

Lead sponsor

Dimitris Chatzitheodorou

Other

Collaborators

  • University of Macedonia, Thessaloniki, Greece

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 26, 2020
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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