Clinical trial NCT04923672: Exercise Preconditioning with Cancer Surgeries
Official title: Evaluation of the Feasibility of Wearable Technology-Guided Exercise Preconditioning to Accelerate Return to Function After Cancer Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Cancer
Hepatobiliary Cancer
Gynecologic Cancer
Keywords: Prehabilitation
Exercise
Physical activity
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to either control group or one of two exercise groups: moderate continuous or high intensity interval training
Primary purpose: PREVENTION

Brief summary: Studies have shown that people who are more physically fit prior to surgery do better after surgery. For this reason, it may be helpful for people who are going to have abdominal surgery for cancer to exercise before surgery to increase fitness. In this study, patients will be assigned to either maintain their current activity, or increase activity to 5 days a week, 40 minutes per day, of either continuous moderate activity or intervals of moderate and vigorous activity (three groups). All participants will wear an Apple watch, and participants in the exercise groups will use a smartphone application to get feedback on activity and encouragement to reach activity goals.

Detailed description: Research indicates that people who have better physical fitness at the time of surgery have a better chance of surviving the surgery and returning to normal function. An exercise intervention in the 3+ weeks before surgery (after the decision that surgery is necessary) may help people who are going to have abdominal surgery for cancer increase fitness prior to surgery. Devices that track physical activity, like smartwatches or Fitbits, allow the wearer to get feedback on physical activity information like steps taken, distance traveled, time in light, moderate or vigorous activity and on heart rate. Having this information and using a smartphone application designed to increase physical activity may help patients increase physical activity and thereby fitness, prior to abdominal surgery for cancer.

The main goal of this project is to test two physical activity interventions and also a "control group" to make sure that participants can do the interventions and to see whether there are changes in activity and fitness in each group:

1. Control group - maintain current activity
2. Moderate continuous activity group - increase activity to 5 days a week, 40 minutes per day, of continuous moderate activity
3. High Intensity Interval Training group - increase activity to 5 days a week, 40 minutes per day, of intervals of moderate and vigorous activity

All participants will wear an Apple watch, and participants in the exercise groups will use a smartphone application to get feedback on activity and encouragement to reach activity goals.

Optional: Participants will also be asked to provide a small amount of blood for research purposes.

Eligibility criteria: 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.
* Study participants must have an Apple iphone to use during the study period

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 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 AST, ALT or Alkaline Phosphatase ≥ 3x 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 ACC/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 outcomes:
measure: Steps per day
timeFrame: Baseline through the 1 day visit prior to surgery
Secondary outcomes:
measure: Enrollment rate
timeFrame: During participant accrual, estimated to take about 12 months
measure: Compliance with EXi smartphone application
timeFrame: From baseline through 1 day visit just prior to surgery
measure: Compliance with exercise intervention, including percentage of exercise goals reached
timeFrame: From baseline through 1 day visit just prior to surgery
measure: Completion/Dropout rate
timeFrame: From baseline through about 30 days after surgery
measure: Percentage of time wearing Apple Watch
timeFrame: From baseline through about 30 days after surgery
measure: Health-related quality of life
timeFrame: Baseline and 1 day of surgery
measure: Pain intensity
timeFrame: Baseline and 1 day of surgery
measure: Pain interference
timeFrame: Baseline and 1 day of surgery
measure: Physical activity level by self report
timeFrame: Baseline and 1 day of surgery
measure: Surgical complications
timeFrame: 30 days after surgery
measure: Length of hospital stay (in days) following surgery
timeFrame: Up to 30 days following surgery
measure: Steps per day
timeFrame: From baseline through 30 days after surgery
measure: Fitness level
timeFrame: Baseline, 1 day prior to surgery, and 30, 90, and 180 days following surgery
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: UVA Health System
state: Virginia
Study officials:
affiliation: UVA
name: Traci Hedrick, MD
role: PRINCIPAL_INVESTIGATOR
References: