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NCT03616873

Early Mobilization of Older Adults in the Cardiovascular Intensive Care Unit

Completed Last updated 14 October 2020
What this trial tests

trial testing Early Mobilization in Physical Activity in 147 participants. Completed in 30 April 2020.

Timeline
22 February 2018
Primary endpoint
30 April 2020
30 April 2020

Quick facts

Lead sponsorLady Davis Institute
StatusCompleted
Study typeOBSERVATIONAL
Enrollment147
Start date22 February 2018
Primary completion30 April 2020
Estimated completion30 April 2020
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Lady Davis Institute

Who can join

60 and older, any sex, with Physical Activity or Older Adults. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An early mobilization (EM) program will be implemented in the Cardiovascular Intensive Care Unit at the Jewish General Hospital (JGH), an academic tertiary hospital in Montreal, Quebec. The investigators will perform a prospective, pre/post-EM intervention study in adults aged ≥60 years old admitted to the Cardiovascular Intensive Care Unit (CICU) at the JGH. During a 3-month period, the investigators will prospectively enrol patients to the pre-intervention cohort. The EM intervention will then be implemented. During a 12-month period, the investigators will prospectively enrol patients to the intervention cohort. 1 and 12 months following hospital discharge, patients in the pre-intervention and post-intervention cohorts will be contacted by phone by a member of the research team to assess for functional status and quality of life measures. The primary effectiveness outcome will be the mean improvement in level of function (LOF) during CICU admission and at 1 and 12 months. Covariates predicting improvement in LOF ("responsiveness") and ones which do not ("non-responsiveness") will be assessed. The recovery of physical function at 1 month and 6 months as measured by the SF-36 physical component summary score will be assessed. The SF-36 scores of the highest scoring tertile of LOF on hospital discharge will be compared with the lowest scoring tertile. Hospital readmission at 30 days and discharge home vs. healthcare facility will also be compared. For safety, the composite and individual components of the number of falls, injuries, and dislodgements over the total number of attempted mobility activities will be recorded. The results from the intervention cohort will be compared to the pre-intervention cohort for all results.

Publications & conference data

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

  1. Health-Related Quality of Life in Older Adults With Acute Cardiovascular Disease Undergoing Early Mobilization.
    Munir H, Morais JA, Goldfarb M. · · 2021 · cited 2× · PMID 34401695 · DOI 10.1016/j.cjco.2021.02.013

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Other trials of Early Mobilization

Trials testing the same drug.

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Currently open trials in the same condition.

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Trials by the same sponsor.

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Data sources for this page

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