Early Mobilization in Older Adults With Acute Cardiovascular Disease

Phase 3

Withdrawn

• Conditions: Older Adults; Acute Cardiovascular Disease; Early Mobilization; Nursing
• Interventions: Behavioral: Early Mobilization; Behavioral: Usual Mobility Care

• Registration Number: NCT04593602
• Lead Sponsor: Lady Davis Institute

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.

Study Timeline

• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-20
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-10
• Study Start: 2023-04-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Early Mobilization Intervention	Early Mobilization	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.
Usual Mobility Care	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.

Primary Outcome Measures

Name	Time	Method
Short Form (SF)-36 Physical Component Summary (PCS) score at 1-month post-hospitalization	1 month post-hospitalization	Health-related quality of life

Secondary Outcome Measures

Name	Time	Method
SF-36 Mental Component Summary score	12 months post-hospitalization	Health-related quality of life
SF-36 Physical Component Scale score	12 months post-hospitalization	Health-related quality of life
Level of Function Mobility Score	12 months post-hospitalization	Functional status
Hospital readmission	12 months post-hospitalization	Resource use outcome