Early Mobilization in Older Adults With Acute Cardiovascular Disease

Status Withdrawn

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04593602
Study type	Interventional
Source	Lady Davis Institute
Contact
Status	Withdrawn
Phase	Phase 3
Start date	April 1, 2023
Completion date	March 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04521374` - The Effects of Texture Modified Diets on Dietary Intake and Appetite Responses in Older Adults	N/A
Completed	`NCT05039879` - Life Improving Factors After a Hip Fracture
Recruiting	`NCT05978336` - SuPA Mobility: Supporting Physical Activity for Mobility in Mobility-Limited Older Adults	N/A
Completed	`NCT02905370` - Progressing Home Health Rehabilitation for Older Adults	N/A
Completed	`NCT03039556` - Step-reduction in Older Men and Women	N/A
Completed	`NCT05901506` - Strengthen Family Members' Understanding of Advance Care Planning With a Nurse-led, Motivational Interview	N/A
Recruiting	`NCT06030128` - Core Stabilization Exercise Therapy in Chronic Lower Back Back Management in Community Dwelling Older Adults	N/A
Completed	`NCT04044183` - Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment or Memory Related Problems and Chronic Pain	N/A
Not yet recruiting	`NCT06323954` - tVNS During Motor Training in Older Adults	N/A
Recruiting	`NCT05366075` - The Preventing Functional Decline in Acutely Hospitalized Older Patients (PREV_FUNC) Study	Phase 3
Completed	`NCT05497960` - Vivo Prediabetes Study: Online, Live, and Interactive Strength Training for Older Adults With Prediabetes	N/A
Recruiting	`NCT05083221` - Effect of an Aural Rehabilitation Program in Hearing-impaired Older Adults	N/A
Completed	`NCT05459103` - Remote Interactive Intervention for Loneliness	N/A
Completed	`NCT05397158` - Optimization of Intestinal Preparation in Older Patients	N/A
Completed	`NCT05025137` - Flexi-Bar and Multi-Component Exercises	N/A
Completed	`NCT04927026` - "Where-there-is-no-psychiatrist Integrated Personal Therapy" Among Community-Dwelling Older Adults	N/A
Completed	`NCT03197038` - Exercise Training and Cognitive Function in Kidney Disease	N/A
Recruiting	`NCT06302686` - engAGE: Managing cognitivE decliNe throuGh Theatre Therapy, Artificial Intelligence and Social Robots drivEn Interventions	N/A
Not yet recruiting	`NCT05078008` - The Role of Balneotherapy in Older Adults With Chronic Low Back Pain	N/A
Terminated	`NCT04144634` - Feasibility of Additional Physiotherapy for Patients Aged 75 and Older	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms