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Early Mobilization of Older Adults in the Cardiovascular Intensive Care Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03616873
Recruitment Status : Completed
First Posted : August 6, 2018
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
Jewish General Hospital
Information provided by (Responsible Party):
Michael Goldfarb, Lady Davis Institute

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Physical Activity Older Adults Cardiovascular Diseases Other: Early Mobilization

Study Design
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Study Type : Observational
Actual Enrollment : 147 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Mobilization of Older Adults in the Cardiovascular Intensive Care Unit
Actual Study Start Date : February 22, 2018
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : April 30, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
Adults aged 60 or older Other: Early Mobilization
The EM program consists of a progression of functional activities from level of function (LOF) 0 (lowest mobility) to 5 (highest mobility). Each LOF has 3 primary activities designed to promote the patient to the next level. The nurse will begin with mobility activities based on the LOF that matches the patient's current status. The nurse and clinical partner will attempt and/or complete each LOF activity once per shift.


Outcome Measures
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Primary Outcome Measures :
  1. Mean change in Level of Function (LOF) scale score during CICU admission and 1 and 12 months post-hospitalization [ Time Frame: Duration of Cardiac Intensive Care Unit stay (average 4 days) and 1 and 12 months post-hosptialization ]
    The mean improvement change in the Level of Function scale score in patients undergoing early mobilization. The Level of Function scale measures mobility and ranges from 0 (bed immobile) to 5 (walking more than 20 meters), with higher scores indicating better mobility.


Secondary Outcome Measures :
  1. Recovery of physical function [ Time Frame: 1 month and 12 months. ]
    Recovery of physical function at 1 month and 12 months as measured by the Short Form (SF)-36 physical component summary score (measures 8 subscales: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role and mental health). The score range is from 0 to 100 and scores are calibrated so that 50 is the average score. Higher scores mean less disability.

  2. Recovery of functional ability [ Time Frame: 1 month and 12 months ]
    The recovery of functional ability at 1 month and 12 months as measured by the Level of Function scale score. The Level of Function scale measures mobility and ranges from 0 (bed immobile) to 5 (walking more than 20 meters), with higher scores indicating better mobility.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the CICU in the early mobilization program aged 60 or older.
Criteria

Inclusion Criteria:

  • Participating in early mobilization program
  • Age 60 years old or older

Exclusion Criteria:

  • CICU stays less than 24 hours
  • Patients with prehospital LOF 0 (immobile), LOF 1 (bedbound) or 2 (can sit in chair only).
  • Cardiac surgery patients will also be excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616873


Locations
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Canada, Quebec
Jewish General Hospital / Lady Davis Institute
Montréal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Lady Davis Institute
Jewish General Hospital
Investigators
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Principal Investigator: Michael Goldfarb, MD Lady Davis Institute
  Study Documents (Full-Text)

Documents provided by Michael Goldfarb, Lady Davis Institute:
Study Protocol and Statistical Analysis Plan  [PDF] November 7, 2018
Informed Consent Form  [PDF] November 7, 2018

More Information
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Responsible Party: Michael Goldfarb, Attending Staff, Division of Cardiology, Lady Davis Institute
ClinicalTrials.gov Identifier: NCT03616873    
Other Study ID Numbers: 17-188
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases