Loading...
Thumbnail Image
Publication

Improving stamina and mobility with preop walking in surgical patients with frailty traits -OASIS IV: randomized clinical trial study protocol

Hoque, Laboni
Dewolf, Ryan
Meyers, David
White, Daniel K.
Mazor, Kathleen M.
Stefan, Mihaela S.
Crawford, Sybil L.
Alavi, Karim
Yates, Jennifer K.
Maxfield, Mark W.
... show 4 more
Embargo Expiration Date
Link to Full Text
Abstract

BACKGROUND: Frail older surgical patients face more than a two-fold increase in postoperative complications, including myocardial infarction, deep vein thrombosis, pulmonary embolism, pneumonia, ileus, and others. Many of these complications occur because of postoperative loss of stamina and poor mobility. Preoperative exercise may better prepare these vulnerable patients for surgery. We present the protocol for our ongoing randomized trial to assess the impact of a preoperative walking intervention with remote coaching and pedometer on outcomes of stamina (six-minute walk distance- 6MWD) and mobility (postoperative steps) in older adults with frailty traits.

METHODS: We will be conducting a randomized clinical trial with a total of 120 patients permitting up to a 33% rate of attrition, to reach a final sample size of 80 (with 40 patients for each study arm). We will include patients who are age 60 or higher, score 4 or greater on the Edmonton Frailty Scale assessment, and will be undergoing a surgical operation that requires a 2 or more night hospital stay to be eligible for our trial. Using block randomization stratified on baseline 6MWD, we will assign patients to wear a pedometer. At the end of three baseline days, an athletic trainer (AT) will provide a daily step count goal reflecting a 10-20% increase from baseline. Subsequently, the AT will call weekly to further titrate the goal or calls more frequently if the patient is not meeting the prescribed goal. Controls will receive general walking advice. Our main outcome is change in 6MWD on postoperative day (POD) 2/3 vs. baseline. We will also collect 6MWD approximately 4 weeks after surgery and daily in-hospital steps.

CONCLUSION: If changes in a 6MWD and step counts are significantly higher for the intervention group, we believe this will confirm our hypothesis that the intervention leads to decreased loss of stamina and mobility. Once confirmed, we anticipate expanding to multiple centers to assess the interventional impact on clinical endpoints.

TRIAL REGISTRATION: The randomized clinical trial was registered on clinicaltrials.gov under the identifier NCT03892187 on March 27, 2019.

Source

Hoque L, Dewolf R, Meyers D, White DK, Mazor KM, Stefan M, Crawford S, Alavi K, Yates J, Maxfield M, Lou F, Uy K, Walz M, Kapoor A. Improving stamina and mobility with preop walking in surgical patients with frailty traits -OASIS IV: randomized clinical trial study protocol. BMC Geriatr. 2020 Oct 7;20(1):394. doi: 10.1186/s12877-020-01799-y. PMID: 33028223; PMCID: PMC7542706. Link to article on publisher's site

Year of Medical School at Time of Visit
Sponsors
Dates of Travel
DOI
10.1186/s12877-020-01799-y
PubMed ID
33028223
Other Identifiers
Notes
Funding and Acknowledgements
Corresponding Author
Related Resources
Related Resources
Repository Citation
Rights
© The Author(s). 2020 Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.