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Completed

NCT Number: NCT03806257

Patient Mobility and Outcomes After Cardiac Surgery

Standards for post-cardiac surgery physical interventions vary between insitutions and there are no published guidelines for national organizations in the U.S. The increasing body of evidence for the effectiveness of physical interventions coupled with variability in how these interventions are implemented suggests a critical need to prospectively determine the impact of clearly defined postoperative physical interventions. This randomized, controlled study seeks to determine the effectiveness of a three-pronged, enhanced, post-operative physical therapy protocol which includes 1) early mobilization, 2) frequent mobilization and ambulation, and 3) patient education on the outcomes of hospital lengths of stay and discharge disposition. The investigators will enroll 220 adult subjects undergoing elective CABG, mitral valve repair or replacement surgery, aortic valve surgery, or combined CABG/valve procedures. Subjects will be randomized to either the control (standard-of-care) group or intervention group (enhanced protocol), and followed for five days. Subjects in each group will wear a FitBit Charge 2 for the duration of the five days following surgery. This will provide both sleep activity and steps data that will be analyzed for sleep quality and distance walked. The primary aim is to assess the difference between groups for ICU and hospital length of stay.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

Patients will be identified based on pre-screening the cardiothoracic surgery schedule. Study staff will visit potential study subjects in the pre-surgical testing clinic to discuss the study's objectives and to ascertain subjects' interest in participating in the study. After providing informed consent, subjects will be randomized using SAS into either the interventional group or standard care group after their surgical procedure is complete and the subject has been transferred to the CVICU. After completion of the surgical procedure, patients who had a major perioperative complication such as stroke, myocardial infarction, pulmonary embolism, hemorrhage requiring massive transfusion (>10 units of PRBCs), intraoperative cardiac arrest, or intraoperative pulmonary arrest, will be considered screen failures and will not be randomized, since the investigators consider the patient enrolled once randomized. Patients randomized to the interventional group will undergo the enhanced physical therapy protocol which includes mobilization from bed to chair on the day of surgery and more frequent ambulation on the subsequent five days.

The main differences between the standard therapy (control) group and intervention group is the timing of post-operative mobilization and ambulation, as well as the point at which they receive gait and safe ambulation training. In the standard therapy group, the patients will receive a FitBit2 after their arrival on the ICU, withstanding any postoperative complications. On POD 1 the subjects routinely get up to the bedside chair with the help of an ICU nurse or physical therapist. The subjects will generally ambulate one-half the circumference of the ICU with assistance, though this is not enforced. On POD2 and onward, the standard therapy group typically will get up to the bedside chair at least once, as well as walk one-half circumference of the ICU, and will receive the standard physical therapy gait and ambulation training. The intervention group will have the FitBit2 watch placed on their wrist on POD 0, along with getting up to the bedside chair. On POD 1, the subjects will get up to the bedside chair twice (as tolerated by patient), and will be asked to walk one-half the ICU circumference. Additionally, the patient's physical therapy and gait/ambulation training will commence on POD 1. On POD 2, the subjects will get up to the bedside chair three times, and will be asked to attempt three walks with the goal of one full ICU circumference.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults 18 years or older undergoing scheduled, elective coronary artery bypass graft (CABG) surgery, mitral valve repair or replacement surgery, aortic valve repair or replacement surgery and combined CABG with one or more valve repair or replacement surgery.

Exclusion criteria

  • Those who do not med the inclusion criteria
  • Pregnant women
  • Prisoners
  • Those patients with skin or systemic infections
  • Those patients who are paraplegic or quadriplegic
  • Those patients who have allergies to polyurethane
  • Any patient who experiences perioperative complications (e.g., stroke, myocardial infarction, pulmonary embolism, hemorrhage requiring massive transfusion (>10 units of PRBCs), intraoperative cardiac arrest, or intraoperative pulmonary arrest

Treatment and study plan

Enhanced Physical Therapy Protocol

Other

A structured physical therapy protocol that requires subject to ambulate more frequently than the standard-of-care patient.

Primary outcomes

  1. Shorter ICU Length of Stay

    Time frame: 1.2 days

    Decrease days in ICU from average standard-of-care patient

  2. Shorter Hospital Length of Stay

    Time frame: 2 days

    Decrease days in hospital from average standard-of-care patient

Secondary outcomes

  1. Composite Clinical Outcome

    Time frame: 5 days

    Combined incidence of pulmonary atelectasis, pneumonia, venous thromboembolism, pulmonary embolism, and mortality.

  2. Longer sleep duration with fewer awakenings

    Time frame: 8 hours sleep, less than 3 awakenings

    Sleep time that is longer than average standard-of-care patient

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Patient Mobility and Outcomes After Cardiac Surgery: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jan 16, 2019
Registry last updated
Oct 4, 2024

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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