Wearable Technology-Guided Exercise to Accelerate Return to Function after Cancer Surgery

Status: administratively complete

This clinical trial tests if preoperative exercise programs, and if using an Apple Smart Watch for tracking exercise, may have an impact on level of physical activity, quality of life and return to baseline function after surgery in patients undergoing surgery for colorectal, hepatobiliary, or gynecologic cancer. An exercise program before surgery may help improve physical function before patients undergo surgery. Improving physical function before surgery may help improve quality of life, reduce recovery time, and shorten time to return to baseline function after surgery.

Inclusion Criteria

Adult (>= 18 years of age) patients undergoing elective abdominal oncologic resection of a confirmed or potential colorectal, hepatobiliary, or gynecologic neoplasm
Study participants must be able to provide written informed consent and authorization
Study participants must be able to understand written and verbal English, as well as to be able to communicate in English

Exclusion Criteria

Any patient unable and/or unwilling to cooperate with all study protocols
Patients who require an assist device (walker) for ambulation
Patients that indicate they did at least 3 days of vigorous intensity activity in the previous 7 days totaling at least 3 hours and 15 minutes OR any combination of walking, moderate-intensity or vigorous-intensity in all of the last 7 days totaling at least 18 and a half hours
Recent history of cardiac disease (within 3 months of registration) that would preclude vigorous exercise
Individuals with end stage renal disease currently on dialysis
Individuals with a history of liver failure as evidenced by aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase >= 3 x upper limit of normal
Individuals with uncontrolled hypertension
Women who are breastfeeding or pregnant
American Society of Anesthesiologists Physical Status score >= 4
Any patient that needs further cardiac evaluation per American College of Cardiology (ACC)/American Heart Association (AHA) perioperative criteria
Surgery scheduled < 3 weeks of study registration (precluding time to participate in exercise regimen)
Any patient who currently uses a fitness tracker or heart rate monitoring-capable device to guide exercise
Patient indicates a lack of familiarity or discomfort with using a smartphone
If participation is not in the best interest of the patient, in the opinion of the treating investigator

PRIMARY OBJECTIVE:

I. To estimate the potential impact of a prescribed, trackable preoperative exercise regimen on increasing pre-surgical physical activity as measured by steps per day.

SECONDARY OBJECTIVES:

I. To estimate the feasibility of using a wearable device to implement a preoperative exercise regimen in patients undergoing elective abdominal oncologic resection.

II. To estimate the potential impact of a prescribed, trackable, preoperative exercise regimen on postoperative patient reported outcomes and return to baseline quality of life.

III. To estimate the impact of a prescribed, trackable, preoperative exercise regimen on postoperative physical activity and fitness and return to baseline function.

EXPLORATORY OBJECTIVES:

I. To assess the patient perspective regarding self-efficacy, motivation, barriers and facilitators to completion of a prescribed, trackable, preoperative exercise regimen

II. To better understand the relationship between patients in this population and technology, including the smartphones and apps used in this study

III. To assess the feasibility of maximum oxygen uptake (VO2 max) testing as a measure of physical fitness in this patient population

IV. To estimate the potential impact of a prescribed, trackable, pre-operative exercise regimen on increasing pre-surgical physical fitness using the VO2max testing in a subset of participants

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM A: Patients wear Apple Smart Watch until day of surgery and then for 30 days after surgery. Patients may optionally undergo collection of blood samples throughout the trial.

ARM B: Patients wear Apple Smart Watch until day of surgery and then for 30 days after surgery. Patients also undergo exercise regimen consisting of moderate continuous training over 40 minutes 5 days a week for at least 3 weeks before surgery. Patients may optionally undergo collection of blood samples throughout the trial.

ARM C: Patients wear Apple Smart Watch until day of surgery and then for 30 days after surgery. Patients also undergo exercise regimen consisting of high intensity interval training over 40 minutes 5 days a week for at least 3 weeks before surgery. Patients may optionally undergo collection of blood samples throughout the trial.

After completion of surgery, patients are followed up at 30, 90, and 180 days.

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Wearable Technology-Guided Exercise to Accelerate Return to Function after Cancer Surgery

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