Fatal and Nonfatal Events Within 14 days After Early, Intensive Mobilization Poststroke
Citation Manager Formats
Make Comment
See Comments

This article requires a subscription to view the full text. If you have a subscription you may use the login form below to view the article. Access to this article can also be purchased.
Abstract
Objective This tertiary analysis from A Very Early Rehabilitation Trial (AVERT) examined fatal and nonfatal serious adverse events (SAEs) at 14 days.
Method AVERT was a prospective, parallel group, assessor blinded, randomized international clinical trial comparing mobility training commenced <24 hours poststroke, termed very early mobilization (VEM), to usual care (UC). Primary outcome was assessed at 3 months. Patients with ischemic or hemorrhagic stroke within 24 hours of onset were included. Treatment with thrombolytics was allowed. Patients with severe premorbid disability or comorbidities were excluded. Interventions continued for 14 days or hospital discharge if less. The primary early safety outcome was fatal SAEs within 14 days. Secondary outcomes were nonfatal SAEs classified as neurologic, immobility-related, and other. Mortality influences were assessed using binary logistic regression adjusted for baseline stroke severity (NIH Stroke Scale [NIHSS] score) and age.
Results A total of 2,104 participants were randomized to VEM (n = 1,054) or UC (n = 1,050) with a median age of 72 years (interquartile range [IQR] 63–80) and NIHSS 7 (IQR 4–12). By 14 days, 48 had died in VEM, 32 in UC, age and stroke severity adjusted odds ratio of 1.76 (95% confidence interval 1.06–2.92, p = 0.029). Stroke progression was more common in VEM. Exploratory subgroup analyses showed higher odds of death in intracerebral hemorrhage and >80 years subgroups, but there was no significant treatment by subgroup interaction. No difference in nonfatal SAEs was found.
Conclusion While the overall case fatality at 14 days poststroke was only 3.8%, mortality adjusted for age and stroke severity was increased with high dose and intensive training compared to usual care. Stroke progression was more common in VEM.
Registration Australian New Zealand Clinical Trials Registry, ACTRN12606000185561.
Classification of Evidence This study provides Class I evidence that very early mobilization increases mortality at 14 days poststroke.
Glossary
- AE=
- adverse event;
- aOR=
- adjusted odds ratio;
- AVERT=
- A Very Early Rehabilitation Trial;
- BP=
- blood pressure;
- CBF=
- cerebral blood flow;
- CI=
- confidence interval;
- IME=
- important medical event;
- IQR=
- interquartile range;
- NIHSS=
- NIH Stroke Scale;
- OR=
- odds ratio;
- rtPA=
- recombinant tissue plasminogen activator;
- SAE=
- serious adverse event;
- UC=
- usual stroke unit care;
- VEM=
- very early mobilization
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
AVERT Trialists Collaboration Group coinvestigators are listed in the appendix 2 at the end of the article.
Coinvestigators are listed at http://links.lww.com/WNL/B261.
Patient page e1269
- Received October 15, 2019.
- Accepted in final form October 5, 2020.
- © 2020 American Academy of Neurology
AAN Members
We have changed the login procedure to improve access between AAN.com and the Neurology journals. If you are experiencing issues, please log out of AAN.com and clear history and cookies. (For instructions by browser, please click the instruction pages below). After clearing, choose preferred Journal and select login for AAN Members. You will be redirected to a login page where you can log in with your AAN ID number and password. When you are returned to the Journal, your name should appear at the top right of the page.
AAN Non-Member Subscribers
Purchase access
For assistance, please contact:
AAN Members (800) 879-1960 or (612) 928-6000 (International)
Non-AAN Member subscribers (800) 638-3030 or (301) 223-2300 option 3, select 1 (international)
Sign Up
Information on how to subscribe to Neurology and Neurology: Clinical Practice can be found here
Purchase
Individual access to articles is available through the Add to Cart option on the article page. Access for 1 day (from the computer you are currently using) is US$ 39.00. Pay-per-view content is for the use of the payee only, and content may not be further distributed by print or electronic means. The payee may view, download, and/or print the article for his/her personal, scholarly, research, and educational use. Distributing copies (electronic or otherwise) of the article is not allowed.
Letters: Rapid online correspondence
- Reader response: Fatal and non-fatal events within 14 days after early, intensive mobilization post stroke
- Varun Kumar Singh, Assistant Professor, Neurology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India
- Anand Kumar, Assistant Professor, Neurology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India
- Abhishek Pathak, Associate Professor, Neurology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India
Submitted November 17, 2020
REQUIREMENTS
You must ensure that your Disclosures have been updated within the previous six months. Please go to our Submission Site to add or update your Disclosure information.
Your co-authors must send a completed Publishing Agreement Form to Neurology Staff (not necessary for the lead/corresponding author as the form below will suffice) before you upload your comment.
If you are responding to a comment that was written about an article you originally authored:
You (and co-authors) do not need to fill out forms or check disclosures as author forms are still valid
and apply to letter.
Submission specifications:
- Submissions must be < 200 words with < 5 references. Reference 1 must be the article on which you are commenting.
- Submissions should not have more than 5 authors. (Exception: original author replies can include all original authors of the article)
- Submit only on articles published within 6 months of issue date.
- Do not be redundant. Read any comments already posted on the article prior to submission.
- Submitted comments are subject to editing and editor review prior to posting.
You May Also be Interested in
Dr. Sevil Yaşar and Dr. Behnam Sabayan
► Watch
Related Articles
Topics Discussed
Alert Me
Recommended articles
-
Article
Prespecified dose-response analysis for A Very Early Rehabilitation Trial (AVERT)Julie Bernhardt, Leonid Churilov, Fiona Ellery et al.Neurology, February 17, 2016 -
Null Hypothesis
Early mobilization and quality of life after strokeFindings from AVERTToby B. Cumming, Leonid Churilov, Janice Collier et al.Neurology, July 26, 2019 -
Patient Page
After a StrokeHow Quickly Should Exercise Begin?Steven Karceski et al.Neurology, February 22, 2021 -
Articles
The Clomethiazole Acute Stroke Study in tissue-type plasminogen activator–treated stroke (CLASS-T)Final resultsP. Lyden, M. Jacoby, J. Schim et al.Neurology, October 09, 2001