Exercise Preconditioning with Cancer Surgeries

NCT04923672 | Terminated DMC

• 1 other identifier: 210103
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Hepatobiliary Cancer; Gynecologic Cancer

Keywords

Prehabilitation; Exercise; Physical activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Enrollment rate

  During participant accrual, estimated to take about 12 months

• Compliance with EXi smartphone application

  From baseline through 1 day visit just prior to surgery

• Compliance with exercise intervention, including percentage of exercise goals reached

  From baseline through 1 day visit just prior to surgery

• Completion/Dropout rate

  From baseline through about 30 days after surgery

• Percentage of time wearing Apple Watch

  From baseline through about 30 days after surgery

Study Arms (3)

Control group

NO INTERVENTION

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.

Moderate continuous training group

ACTIVE COMPARATOR

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

High intensity interval training group

ACTIVE COMPARATOR

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

Interventions

Moderate continuous exercise 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.

Moderate continuous training group

High intensity interval exercise 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.

High intensity interval training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

UVA Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Traci Hedrick, MD

  UVA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomization to either control group or one of two exercise groups: moderate continuous or high intensity interval training

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 11, 2021
• Study Start: February 20, 2023
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)