Early Mobilization of Older Adults in the Cardiovascular Intensive Care Unit

NCT03616873 | Completed

• 1 other identifier: 17-188
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity; Older Adults; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Recovery of physical function

  1 month and 12 months.

• Recovery of functional ability

  1 month and 12 months

Study Arms (1)

Adults aged 60 or older

Other: Early Mobilization

Interventions

Early Mobilization OTHER

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.

Adults aged 60 or older

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the CICU in the early mobilization program aged 60 or older.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lady Davis Institute: lead
• Jewish General Hospital: collaborator

Study Sites (1)

Jewish General Hospital / Lady Davis Institute

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Motor Activity; Cardiovascular Diseases

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Michael Goldfarb, MD

  Lady Davis Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Staff, Division of Cardiology

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: August 6, 2018
• Study Start: February 22, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)