Patient Mobility and Outcomes After Cardiac Surgery

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiac Rehabilitation
• Intervention / Treatment: Other: Enhanced Physical Therapy Protocol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Subjects in the control arm will receive standard of care, which consists of mobilization to a bedside chair at least once, and ambulate one-half ICU circumference on postoperative day one. On postoperative days two through five, the subject will be mobilized to the bedside chair at least once, and ambulated at least once with target of one full ICU circumference. These subjects will receive gait training and safe ambulation education, and wear a FitBit Charge 2 watch for five days after surgery.
Experimental: Enhanced Physical Therapy Protocol; Subjects in the experimental arm will recieve a FitBit Charge 2 watch, and will be mobilized to the bedside chair on postoperative day zero. On postoperative day two subjects will be mobilized to the bedside chair twice, ambulate one-half of the ICU circumference, and receive gait and safe ambulation training. On postoperative days two through five, subjects will mobilize to the bedside chair three times, and will be encouraged to ambulate three times, each time with a target of one full ICU circumference.	Other: Enhanced Physical Therapy Protocol; A structured physical therapy protocol that requires subject to ambulate more frequently than the standard-of-care patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shorter ICU Length of Stay	Decrease days in ICU from average standard-of-care patient	1.2 days
Shorter Hospital Length of Stay	Decrease days in hospital from average standard-of-care patient	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Clinical Outcome	Combined incidence of pulmonary atelectasis, pneumonia, venous thromboembolism, pulmonary embolism, and mortality.	5 days
Longer sleep duration with fewer awakenings	Sleep time that is longer than average standard-of-care patient	8 hours sleep, less than 3 awakenings

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Estimated): June 28, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STU 012018-090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not share data with any outside entity or non-IRB-approved personnel.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No