Previously submitted to: JMIR Research Protocols (no longer under consideration since Oct 15, 2020)
Date Submitted: Aug 5, 2020
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Improving Stamina and Mobility with Preop Walking bolstered by Modern Pedometer and Remote Coaching with Telephone Support in Surgical Patients with Frailty Traits – OASIS IV: Randomized Clinical Trial Study Protocol
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.
Objective:
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 plan to conduct a randomized clinical trial. Eligible patients are age 60 or higher, scoring 4 or greater on the Edmonton Frailty Scale assessment, and undergoing a surgical operation that requires a 2 or more night hospital stay. Using block randomization stratified on baseline 6MWD, we assign patients to wear a pedometer. At the end of three baseline days, an athletic trainer (AT) provides a daily step count goal reflecting a 10-20% increase from baseline. Subsequently, the AT calls weekly to further titrate the goal or calls more frequently if the patient is not meeting the prescribed goal. Controls receive general walking advice. Our main outcome is change in 6MWD on postoperative day (POD) 2/3 vs. baseline. We also collect 6MWD approximately 4 weeks after surgery and daily in-hospital steps.
Results:
After an initial pilot phase that ran from June 2019 to December 2019, as of July 2020, we have enrolled 14 patients. We have a total of 6 intervention patients and 8 control patients participating in the trial. Funding has been secured till December 2020.
Conclusions:
If changes in 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. Clinical Trial: The randomized clinical trial was registered on clinicaltrials.gov under the identifier NCT03892187 on March 27, 2019. URL: https://clinicaltrials.gov/ct2/show/NCT03892187
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