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NCT04593602 Clinical Trial

Early Mobilization in Older Adults With Acute Cardiovascular Disease

Older Adults Clinical Trial

— EM-HEART  

Official title:
Early Mobilization in Older Adults With Acute Cardiovascular Disease: A Prospective, Multi-centre Stepped Wedge Cluster Randomized Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04593602
Other study ID # Lady Davis Institute
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date April 1, 2023
Est. completion date March 2024

Study information
Verified date March 2023
Source Lady Davis Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date March 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Early Mobilization
Nurse-driven early mobilization activities twice daily
• Usual Mobility Care
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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Lady Davis Institute

References & Publications (1)

Semsar-Kazerooni K, Dima D, Valiquette J, Berube-Dufour J, Goldfarb M. Early Mobilization in People With Acute Cardiovascular Disease. Can J Cardiol. 2021 Feb;37(2):232-240. doi: 10.1016/j.cjca.2020.03.038. Epub 2020 Apr 2. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Short Form (SF)-36 Physical Component Summary (PCS) score at 1-month post-hospitalization Health-related quality of life 1 month post-hospitalization
Secondary SF-36 Physical Component Scale score Health-related quality of life 12 months post-hospitalization
Secondary SF-36 Mental Component Summary score Health-related quality of life 1 month post-hospitalization
Secondary SF-36 Mental Component Summary score Health-related quality of life 12 months post-hospitalization
Secondary Level of Function Mobility Score Functional status 1 month post-hospitalization
Secondary Level of Function Mobility Score Functional status 12 months post-hospitalization
Secondary Hospital readmission Resource use outcome 1 month post-hospitalization
Secondary Hospital readmission Resource use outcome 12 months post-hospitalization
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