Exercise Preconditioning With Cancer Surgeries (ExPre 01)

Evaluation of the Feasibility of Wearable Technology-Guided Exercise Preconditioning to Accelerate Return to Function After Cancer Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer; Colorectal Cancer; Hepatobiliary Cancer
• Intervention / Treatment: Behavioral: Moderate continuous exercise; Behavioral: High intensity interval exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 57
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ryan Gombita; Phone Number: (434) 924-5529; Email: KRA9HY@uvahealth.org
• Study Contact Backup: Name: Tarra Taylor; Phone Number: (434) 243-8107; Email: tot2g@uvahealth.org

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • UVA Health System
      • Principal Investigator: Traci Hedrick, MD
      • Sub-Investigator: Robert Thiele, MD
      • Sub-Investigator: Laura Barnes, PhD
      • Contact: Ryan Gombita; Phone Number: 434-924-5529; Email: KRA9HY@uvahealth.org
      • Contact: Tarra Taylor; Phone Number: 4342438107; Email: tot2g@uvahealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Participants will be asked to wear an Apple watch through about 30 days after surgery and will be asked to maintain their current activity level.
Active Comparator: Moderate continuous training group; Apple watch and a smartphone application Increase activity to 5 days a week, 40 minutes a day of continuous moderate intensity exercise prior to surgery.	Behavioral: Moderate continuous exercise; Participants will be asked to wear an Apple watch and use a smartphone application to help increase their activity to 5 days a week, about 40 minutes a day of continuous moderate intensity exercise prior to surgery. They will be asked to continue wearing the watch through about 30 days after surgery.
Active Comparator: High intensity interval training group; Apple watch and a smartphone application Increase activity to 5 days a week, 40 minutes a day of intervals of high and moderate intensity exercise prior to surgery.	Behavioral: High intensity interval exercise; Participants will be asked to wear an Apple watch and use a smartphone application to help increase their activity to 5 days a week, about 40 minutes a day of intervals of high and moderate intensity exercise prior to surgery. They will be asked to continue wearing the watch through about 30 days after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Steps per day	Change in average steps per day measured at baseline and at the time of surgery	Baseline through the 1 day visit prior to surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate	Number of participants enrolled per month	During participant accrual, estimated to take about 12 months
Compliance with EXi smartphone application	To assess feasibility of the intervention	From baseline through 1 day visit just prior to surgery
Compliance with exercise intervention, including percentage of exercise goals reached	To assess feasibility of the intervention	From baseline through 1 day visit just prior to surgery
Completion/Dropout rate	To assess feasibility of the intervention	From baseline through about 30 days after surgery
Percentage of time wearing Apple Watch	To assess feasibility of the intervention	From baseline through about 30 days after surgery
Health-related quality of life	As measured by PROMIS Global Health Scale	Baseline and 1 day of surgery
Pain intensity	As measured by PROMIS Pain intensity	Baseline and 1 day of surgery
Pain interference	As measured by PROMIS Pain interference	Baseline and 1 day of surgery
Physical activity level by self report	As measured by the International Physical Activity Questionnaire	Baseline and 1 day of surgery
Surgical complications	Based on review of medical records	30 days after surgery
Length of hospital stay (in days) following surgery	Days participant stayed in hospital following surgery date	Up to 30 days following surgery
Steps per day	Measured by Apple Watch	From baseline through 30 days after surgery
Fitness level	As measured by 6 minute walk test	Baseline, 1 day prior to surgery, and 30, 90, and 180 days following surgery

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Traci Hedrick, MD, UVA

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Physical activity; Prehabilitation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 210103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No