Patient Mobility and Outcomes After Cardiac Surgery

NCT03806257 | Completed

• 1 other identifier: STU 012018-090
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Composite Clinical Outcome

  5 days

• Longer sleep duration with fewer awakenings

  8 hours sleep, less than 3 awakenings

Study Arms (2)

Control

NO INTERVENTION

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.

Enhanced Physical Therapy Protocol

EXPERIMENTAL

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

Interventions

Enhanced Physical Therapy Protocol OTHER

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

Enhanced Physical Therapy Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Herdy AH, Marcchi PL, Vila A, Tavares C, Collaco J, Niebauer J, Ribeiro JP. Pre- and postoperative cardiopulmonary rehabilitation in hospitalized patients undergoing coronary artery bypass surgery: a randomized controlled trial. Am J Phys Med Rehabil. 2008 Sep;87(9):714-9. doi: 10.1097/PHM.0b013e3181839152.

  PMID: 18716482 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled prospective design involving two study groups: 1) standard-of-care for cardiac physical therapy, and 2) enhanced protocol for cardiac physical therapy. Primary aim is to assess difference, if any, between groups for ICU and hospital length of stay.

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: March 28, 2018
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)