Exercise Preconditioning with Cancer Surgeries

NCT ID: NCT04923672

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2024-09-12

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.

Conditions

Colorectal Cancer; Hepatobiliary Cancer; Gynecologic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Moderate continuous exercise

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

High intensity interval exercise

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Traci Hedrick, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Traci Hedrick, MD

Role: PRINCIPAL_INVESTIGATOR

UVA

Locations

UVA Health System

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

210103

Identifier Type: -

Identifier Source: org_study_id