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Patient Mobility and Outcomes After Cardiac Surgery

NCT03806257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2024-10-04

No results posted yet for this study

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

Interventions

OTHER

Enhanced Physical Therapy Protocol

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

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-28
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03806257 on ClinicalTrials.gov