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Exercise Preconditioning With Cancer Surgeries (ExPre 01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04923672
Recruitment Status : Not yet recruiting
First Posted : June 11, 2021
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Traci Hedrick, MD, University of Virginia

Tracking Information
First Submitted Date  ICMJE June 7, 2021
First Posted Date  ICMJE June 11, 2021
Last Update Posted Date June 11, 2021
Estimated Study Start Date  ICMJE August 1, 2021
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2021)
Steps per day [ Time Frame: Baseline through the 1 day visit prior to surgery ]
Change in average steps per day measured at baseline and at the time of surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2021)
  • Enrollment rate [ Time Frame: During participant accrual, estimated to take about 12 months ]
    Number of participants enrolled per month
  • Compliance with EXi smartphone application [ Time Frame: From baseline through 1 day visit just prior to surgery ]
    To assess feasibility of the intervention
  • Compliance with exercise intervention, including percentage of exercise goals reached [ Time Frame: From baseline through 1 day visit just prior to surgery ]
    To assess feasibility of the intervention
  • Completion/Dropout rate [ Time Frame: From baseline through about 30 days after surgery ]
    To assess feasibility of the intervention
  • Percentage of time wearing Apple Watch [ Time Frame: From baseline through about 30 days after surgery ]
    To assess feasibility of the intervention
  • Health-related quality of life [ Time Frame: Baseline and 1 day of surgery ]
    As measured by PROMIS Global Health Scale
  • Pain intensity [ Time Frame: Baseline and 1 day of surgery ]
    As measured by PROMIS Pain intensity
  • Pain interference [ Time Frame: Baseline and 1 day of surgery ]
    As measured by PROMIS Pain interference
  • Physical activity level by self report [ Time Frame: Baseline and 1 day of surgery ]
    As measured by the International Physical Activity Questionnaire
  • Surgical complications [ Time Frame: 30 days after surgery ]
    Based on review of medical records
  • Length of hospital stay (in days) following surgery [ Time Frame: Up to 30 days following surgery ]
    Days participant stayed in hospital following surgery date
  • Steps per day [ Time Frame: From baseline through 30 days after surgery ]
    Measured by Apple Watch
  • Fitness level [ Time Frame: Baseline, 1 day prior to surgery, and 30, 90, and 180 days following surgery ]
    As measured by 6 minute walk test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Preconditioning With Cancer Surgeries
Official Title  ICMJE Evaluation of the Feasibility of Wearable Technology-Guided Exercise Preconditioning to Accelerate Return to Function After Cancer Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomization to either control group or one of two exercise groups: moderate continuous or high intensity interval training
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Colorectal Cancer
  • Hepatobiliary Cancer
  • Gynecologic Cancer
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • No Intervention: 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.
  • Active Comparator: 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.

    Intervention: Behavioral: Moderate continuous exercise
  • Active Comparator: 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.

    Intervention: Behavioral: High intensity interval exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 10, 2021)
57
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2023
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 score "High" on the IPAQ questionnaire (indicating they already do at least 3 days of vigorous intensity activity (≥1500 MET minutes/week) OR ≥7 days of any combination of walking, moderate-intensity or vigorous-intensity (≥3000 MET minutes/week)
  • 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 hemoglobin less than 11 d/gL for women and less than 14 d/gL for men
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cara Hanby, BS 434-924-9841 CLH5KE@hscmail.mcc.virginia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04923672
Other Study ID Numbers  ICMJE 210103
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Traci Hedrick, MD, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Traci Hedrick, MD UVA
PRS Account University of Virginia
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP