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Background: Major surgery is associated with substantial morbidity and reduced quality of life, particularly in the elderly and frail with impaired functional capacity. Multimodal prehabilitation can enhance functional recovery after surgery and reduce postoperative complications. Digital prehabilitation applications gained momentum being a resource-sparing tool improving patients’ preoperative status. Still, little is known regarding their safety and accuracy as medical devices.
Methods: The PROTEGO MAXIMA trial was a prospective interventional pilot trial assessing the validity, accuracy, and safety of an app-based exercise program. The Prehab App calculates an individual, risk-stratified aerobic interval training based on risk factors and uses wearables for heart rate monitoring. Healthy students and patients undergoing major surgery were enrolled. Structured risk assessment was performed followed by a 6-min walking test and a 37-min supervised interval. During the exercise, patients wore App-linked wearables for heart rate and distance measurement, which were compared to standard ECG and treadmill measurements. Safety and usability assessments included testing of alarm signals, and occurrence of adverse events.
Findings: Seventy-five participants were included. Mean heart rate differences between wearables and standard ECG were ≤5bpm with a mean absolute percentage error (MAPE) ≤5%. Regression analysis revealed a significant impact of the body mass index (BMI) (OR 0·897, 95% CI [0·822, 0·980], P = 0·016) and TUG-score (OR 0·122, 95% CI [0·027, 0·546], P = 0·006) on the accuracy of heart rate measurement. Twenty-nine (38·7%) patients experienced adverse events: pain (41·7%), ECG electrode-related skin irritations (16·7%), dizziness (16·7%), shortness of breath (16·7%), and fatigue (8·2%). No cardiovascular, or serious adverse event was reported, and no serious device deficiency was detected.
Interpretation: The interventional trial showed high safety of the exercise program and accuracy of heart rate measurements using commercial wearables in patients before major surgery allowing a remote setting in the future.
Funding: Else-Kroener-Fresenius Stiftung (number: 2021_EKTP10).
