Clinical trial NCT03616873: Early Mobilization of Older Adults in the Cardiovascular Intensive Care Unit
Official title: Early Mobilization of Older Adults in the Cardiovascular Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Older Adults
Cardiovascular Diseases
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
Collaborators: name: Jewish General Hospital
First posted: 2018-08-06
Enrollment: 147
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the CICU in the early mobilization program aged 60 or older.

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.


Eligibility 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.

Primary outcomes:
measure: Mean change in Level of Function (LOF) scale score during CICU admission and 1 and 12 months post-hospitalization
timeFrame: Duration of Cardiac Intensive Care Unit stay (average 4 days) and 1 and 12 months post-hosptialization
Secondary outcomes:
measure: Recovery of physical function
timeFrame: 1 month and 12 months.
measure: Recovery of functional ability
timeFrame: 1 month and 12 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital / Lady Davis Institute
state: Quebec
Study officials:
affiliation: Lady Davis Institute
name: Michael Goldfarb, MD
role: PRINCIPAL_INVESTIGATOR
References: