Early Mobilization in Older Adults With Acute Cardiovascular Disease (EM-HEART)

Lady Davis Institute

Status and phase: Withdrawn; Phase 3

Conditions: Acute Cardiovascular Disease; Early Mobilization; Older Adults; Nursing

Treatments: Behavioral: Early Mobilization; Behavioral: Usual Mobility Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04593602

Lady Davis Institute

Details and patient eligibility

About

The EM-HEART study is a prospective, multi-centre stepped wedge cluster randomized trial to evaluate the effectiveness of a pragmatic early mobilization (EM) program to improve patient-centred and clinical outcomes in older adults with acute CV disease. There will be 256 participants ≥60 years old with acute CV disease enrolled at 6 participating Canadian hospitals. The study will investigate whether EM improves functional status during admission, as compared to usual care, and whether this leads to improved health-related quality of life post-hospitalization. Functional status will be measured with the validated Level of Function Mobility Scale. The primary outcome will be the Short-Form SF-36 physical component scale score at 1-month post-hospitalization. Secondary outcomes include functional status and hospital readmission at 1-month post-hospitalization.

Full description

The EM-HEART study is a prospective, multi-centre stepped wedge cluster randomized trial to evaluate the effectiveness of a pragmatic EM program to improve patient-centred and clinical outcomes in older adults with acute CV disease. There will be 256 participants ≥60 years old with acute CV disease enrolled at 6 participating Canadian hospitals. The study will investigate whether EM improves functional status during admission, as compared to usual care, and whether this leads to improved health-related quality of life post-hospitalization. Functional status will be measured with the validated Level of Function Mobility Scale. The primary outcome will be the Short-Form SF-36 physical component scale score at 1-month post-hospitalization. Secondary outcomes include functional status and hospital readmission at 1-month post-hospitalization. Nested cohort studies will explore (1) the relationship between EM, sedentary time, and posthospitalization outcomes and (2) the impact of EM on muscle mass loss and inflammation in older adults with acute CV disease.

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥ 60 years
• no planned cardiac surgery during admission

Exclusion criteria

• projected cardiac ICU stays less than 24 hours
• patients unable to complete follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Early Mobilization Intervention

Experimental group

Description:

The bedside nurse determines the prehospital Level of Function based on patient and family report and current Level of Function based on nursing mobility assessment. Each Level of Function has 3 primary activities designed to promote the patient to the next level. The nurse leads mobility activities based on the patient's current Level of Function once per shift, twice daily (AM+PM). If a patient is able to complete each of the 3 activities, the nurse on the subsequent shift will assess whether the Level of Function can be advanced. Physiotherapy consultation is available if required, although not obligatory. Patients are encouraged to spend as much time in the chair and ambulatory as possible.

Treatment:

Behavioral: Early Mobilization

Usual Mobility Care

Active Comparator group

Description:

Usual mobility care involves following physician orders for mobilization (i.e., bedrest, mobilization to chair with meals, physiotherapy consultation and care) as per local practice.

Treatment:

Behavioral: Usual Mobility Care