Clinical trial NCT04593602: Early Mobilization in Older Adults With Acute Cardiovascular Disease
Official title: Early Mobilization in Older Adults With Acute Cardiovascular Disease: A Prospective, Multi-centre Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Early Mobilization
Older Adults
Acute Cardiovascular Disease
Nursing
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In the stepped-wedge cluster design, there is random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The nature of the intervention requires randomization of entire units to the intervention with associated mobility culture change and this precludes a standard randomized controlled trial design (i.e., randomization of some patients to the intervention but not others). The stepped-wedge design allows each site to function as its own control.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Short Form (SF)-36 Physical Component Summary (PCS) score at 1-month post-hospitalization
timeFrame: 1 month post-hospitalization
Secondary outcomes:
measure: SF-36 Physical Component Scale score
timeFrame: 12 months post-hospitalization
measure: SF-36 Mental Component Summary score
timeFrame: 1 month post-hospitalization
measure: SF-36 Mental Component Summary score
timeFrame: 12 months post-hospitalization
measure: Level of Function Mobility Score
timeFrame: 1 month post-hospitalization
measure: Level of Function Mobility Score
timeFrame: 12 months post-hospitalization
measure: Hospital readmission
timeFrame: 1 month post-hospitalization
measure: Hospital readmission
timeFrame: 12 months post-hospitalization
Other outcomes:
Locations:
Study officials:
References:
citation: 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.