Exercise Preconditioning With Cancer Surgeries

Colorectal Cancer Clinical Trial

— ExPre 01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04923672
• Other study ID #: 210103
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: August 2023
• Source: University of Virginia
• Contact: Ryan Gombita
• Phone: (434) 924-5529
• Email: KRA9HY[@]uvahealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Gynecologic Cancer
• Hepatobiliary Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UVA Health System	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

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