Exercise Preconditioning with Cancer Surgeries
Key facts
- Who runs it
- University of Virginia
- Where
- Charlottesville, United StatesSee the site
- Trial code
- Status
- Terminated
- People taking part
- 10 people enrolled
- Started
- 20 Feb 2023
- Ended
- 12 Sept 2024
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Moderate continuous exercise
- High intensity interval exercise
- Record updated
- 16 October 2024
- Why it stopped
- Company providing the computer application for exercise intervention suddenly closed for business
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Individuals with end stage renal disease currently on dialysis
- Surgery scheduled < 3 weeks of study registration (precluding time to participate in exercise regimen)
- Recent history of cardiac disease (within 3 months of registration) that would preclude vigorous exercise
- Individuals with uncontrolled hypertension
- Any patient that needs further cardiac evaluation per ACC/AHA perioperative criteria
- Any patient who currently uses a fitness tracker or heart rate monitoring-capable device to guide exercise
- Individuals with a history of liver failure as evidenced by AST, ALT or Alkaline Phosphatase ≥ 3x upper limit of normal
- Any patient unable and/or unwilling to cooperate with all study protocols
- Patients who require an assist device (walker) for ambulation
- Women who are breastfeeding or pregnant
- American Society of Anesthesiologists Physical Status score ≥ 4
- 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
Where in United States
- Uva Health SystemCharlottesville, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Control groupNo study treatment, for comparison
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 groupExisting treatment, for comparison
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.
Treatment: Moderate continuous exercise
- High intensity interval training groupExisting treatment, for comparison
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.
Treatment: High intensity interval exercise
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of the Feasibility of Wearable Technology-Guided Exercise Preconditioning to Accelerate Return to Function After Cancer Surgery
- Record updated
- 16 October 2024