Exercise Preconditioning with Cancer Surgeries

Not Applicable

Terminated

• Conditions: Hepatobiliary Cancer; Gynecologic Cancer; Colorectal Cancer
• Interventions: Behavioral: Moderate continuous exercise; Behavioral: High intensity interval exercise

• Registration Number: NCT04923672
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-11
• Study Start: 2023-02-20
• Primary Completion: 2024-09-12
• Study Completion: 2024-09-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate continuous training group	Moderate continuous exercise	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.
High intensity interval training group	High intensity interval exercise	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.

Primary Outcome Measures

Name	Time	Method
Steps per day	Baseline through the 1 day visit prior to surgery	Change in average steps per day measured at baseline and at the time of surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UVA Health System; 🇺🇸 Charlottesville, Virginia, United States