Back to resultsExercise Preconditioning With Cancer Surgeries (ExPre 01)
Primary Purpose
Colorectal Cancer, Hepatobiliary Cancer, Gynecologic Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moderate continuous exercise
High intensity interval exercise
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring Prehabilitation, Exercise, Physical activity
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
Sites / Locations
- UVA Health SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control group
Moderate continuous training group
High intensity interval training group
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Steps per day
Change in average steps per day measured at baseline and at the time of surgery
Secondary Outcome Measures
Enrollment rate
Number of participants enrolled per month
Compliance with EXi smartphone application
To assess feasibility of the intervention
Compliance with exercise intervention, including percentage of exercise goals reached
To assess feasibility of the intervention
Completion/Dropout rate
To assess feasibility of the intervention
Percentage of time wearing Apple Watch
To assess feasibility of the intervention
Health-related quality of life
As measured by PROMIS Global Health Scale
Pain intensity
As measured by PROMIS Pain intensity
Pain interference
As measured by PROMIS Pain interference
Physical activity level by self report
As measured by the International Physical Activity Questionnaire
Surgical complications
Based on review of medical records
Length of hospital stay (in days) following surgery
Days participant stayed in hospital following surgery date
Steps per day
Measured by Apple Watch
Fitness level
As measured by 6 minute walk test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04923672
Brief Title
Exercise Preconditioning With Cancer Surgeries
Acronym
ExPre 01
Official Title
Evaluation of the Feasibility of Wearable Technology-Guided Exercise Preconditioning to Accelerate Return to Function After Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
Control group - maintain current activity
Moderate continuous activity group - increase activity to 5 days a week, 40 minutes per day, of continuous moderate activity
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Hepatobiliary Cancer, Gynecologic Cancer
Keywords
Prehabilitation, Exercise, Physical activity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization to either control group or one of two exercise groups: moderate continuous or high intensity interval training
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Moderate continuous training group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High intensity interval training group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Moderate continuous exercise
Intervention Description
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
Intervention Name(s)
High intensity interval exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Steps per day
Description
Change in average steps per day measured at baseline and at the time of surgery
Time Frame
Baseline through the 1 day visit prior to surgery
Secondary Outcome Measure Information:
Title
Enrollment rate
Description
Number of participants enrolled per month
Time Frame
During participant accrual, estimated to take about 12 months
Title
Compliance with EXi smartphone application
Description
To assess feasibility of the intervention
Time Frame
From baseline through 1 day visit just prior to surgery
Title
Compliance with exercise intervention, including percentage of exercise goals reached
Description
To assess feasibility of the intervention
Time Frame
From baseline through 1 day visit just prior to surgery
Title
Completion/Dropout rate
Description
To assess feasibility of the intervention
Time Frame
From baseline through about 30 days after surgery
Title
Percentage of time wearing Apple Watch
Description
To assess feasibility of the intervention
Time Frame
From baseline through about 30 days after surgery
Title
Health-related quality of life
Description
As measured by PROMIS Global Health Scale
Time Frame
Baseline and 1 day of surgery
Title
Pain intensity
Description
As measured by PROMIS Pain intensity
Time Frame
Baseline and 1 day of surgery
Title
Pain interference
Description
As measured by PROMIS Pain interference
Time Frame
Baseline and 1 day of surgery
Title
Physical activity level by self report
Description
As measured by the International Physical Activity Questionnaire
Time Frame
Baseline and 1 day of surgery
Title
Surgical complications
Description
Based on review of medical records
Time Frame
30 days after surgery
Title
Length of hospital stay (in days) following surgery
Description
Days participant stayed in hospital following surgery date
Time Frame
Up to 30 days following surgery
Title
Steps per day
Description
Measured by Apple Watch
Time Frame
From baseline through 30 days after surgery
Title
Fitness level
Description
As measured by 6 minute walk test
Time Frame
Baseline, 1 day prior to surgery, and 30, 90, and 180 days following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Gombita
Phone
(434) 924-5529
Email
KRA9HY@uvahealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Tarra Taylor
Phone
(434) 243-8107
Email
tot2g@uvahealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Traci Hedrick, MD
Organizational Affiliation
UVA
Official's Role
Principal Investigator
Facility Information:
Facility Name
UVA Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Gombita
Phone
434-924-5529
Email
KRA9HY@uvahealth.org
First Name & Middle Initial & Last Name & Degree
Tarra Taylor
Phone
4342438107
Email
tot2g@uvahealth.org
First Name & Middle Initial & Last Name & Degree
Traci Hedrick, MD
First Name & Middle Initial & Last Name & Degree
Robert Thiele, MD
First Name & Middle Initial & Last Name & Degree
Laura Barnes, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exercise Preconditioning With Cancer Surgeries
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