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NCT03806257

Patient Mobility and Outcomes After Cardiac Surgery

Completed NA Last updated 4 October 2024
What this trial tests

NA trial testing Enhanced Physical Therapy Protocol in Cardiac Rehabilitation in 250 participants. Completed in 30 June 2024.

Timeline
28 March 2018
Primary endpoint
30 June 2024
30 June 2024

Quick facts

Lead sponsorUniversity of Texas Southwestern Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment250
Start date28 March 2018
Primary completion30 June 2024
Estimated completion30 June 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Texas Southwestern Medical Center

Who can join

18 and older, any sex, with Cardiac Rehabilitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Definitions of massive transfusion in adults with critical bleeding: a systematic review.
    Lin VS, Sun E, Yau S, Abeyakoon C, et al · · 2023 · cited 35× · PMID 37407998 · DOI 10.1186/s13054-023-04537-z

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Other recruiting trials for Cardiac Rehabilitation

Currently open trials in the same condition.

Other University of Texas Southwestern Medical Center trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03806257.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing