Colorectal Cancer Clinical Trial
— ExPre 01Official title:
Evaluation of the Feasibility of Wearable Technology-Guided Exercise Preconditioning to Accelerate Return to Function After Cancer Surgery
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | UVA Health System | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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