Early Mobilization of Older Adults in the Cardiovascular Intensive Care Unit

Cardiovascular Diseases Clinical Trial

Official title:

Early Mobilization of Older Adults in the Cardiovascular Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03616873
• Other study ID #: 17-188
• Status: Completed
• Start date: February 22, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: October 2020
• Source: Lady Davis Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Older Adults
• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
Canada	Jewish General Hospital / Lady Davis Institute	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Lady Davis Institute	Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Level of Function (LOF) scale score during CICU admission and 1 and 12 months post-hospitalization	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.	Duration of Cardiac Intensive Care Unit stay (average 4 days) and 1 and 12 months post-hosptialization
Secondary	Recovery of physical function	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.	1 month and 12 months.
Secondary	Recovery of functional ability	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.	1 month and 12 months