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 (Preprint)
Bibliographic record
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. CLINICALTRIAL 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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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.009 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.006 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.004 | 0.005 |
| Insufficient payload (model declined to judge) | 0.050 | 0.010 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".