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Completed

NCT Number: NCT03616873

Early Mobilization of Older Adults in the Cardiovascular Intensive Care Unit

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.

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Key information

Conditions

Physical Activity Behavior Cardiovascular Diseases Motor Activity Older Adults

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jewish General Hospital / Lady Davis Institute

Montreal, Quebec, H3T 1E2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Lady Davis Institute

Other

Collaborators

  • Jewish General Hospital

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2018
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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