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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Nurse-driven early mobilization activities twice daily
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.
Short Form (SF)-36 Physical Component Summary (PCS) score at 1-month post-hospitalization
Health-related quality of life
Time frame: 1 month post-hospitalization
SF-36 Physical Component Scale score
Health-related quality of life
Time frame: 12 months post-hospitalization
SF-36 Mental Component Summary score
Health-related quality of life
Time frame: 1 month post-hospitalization
SF-36 Mental Component Summary score
Health-related quality of life
Time frame: 12 months post-hospitalization
Level of Function Mobility Score
Functional status
Time frame: 1 month post-hospitalization
Level of Function Mobility Score
Functional status
Time frame: 12 months post-hospitalization
Hospital readmission
Resource use outcome
Time frame: 1 month post-hospitalization
Hospital readmission
Resource use outcome
Time frame: 12 months post-hospitalization
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