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Company providing the computer application for exercise intervention suddenly closed for business
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | 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 group | Active Comparator | 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. |
|
| High intensity interval training group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate continuous exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment rate | Number of participants enrolled per month | During participant accrual, estimated to take about 12 months |
| Compliance with EXi smartphone application | To assess feasibility of the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Traci Hedrick, MD | UVA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UVA Health System | Charlottesville | Virginia | 22908 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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Randomization to either control group or one of two exercise groups: moderate continuous or high intensity interval training
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|
| High intensity interval exercise | Behavioral | 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. |
|
| From baseline through 1 day visit just prior to surgery |
| 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 |
| Completion/Dropout rate | To assess feasibility of the intervention | From baseline through about 30 days after surgery |
| Percentage of time wearing Apple Watch | To assess feasibility of the intervention | From baseline through about 30 days after surgery |
| Health-related quality of life | As measured by PROMIS Global Health Scale | Baseline and 1 day of surgery |
| Pain intensity | As measured by PROMIS Pain intensity | Baseline and 1 day of surgery |
| Pain interference | As measured by PROMIS Pain interference | Baseline and 1 day of surgery |
| Physical activity level by self report | As measured by the International Physical Activity Questionnaire | Baseline and 1 day of surgery |
| Surgical complications | Based on review of medical records | 30 days after surgery |
| Length of hospital stay (in days) following surgery | Days participant stayed in hospital following surgery date | Up to 30 days following surgery |
| Steps per day | Measured by Apple Watch | From baseline through 30 days after surgery |
| Fitness level | As measured by 6 minute walk test | Baseline, 1 day prior to surgery, and 30, 90, and 180 days following surgery |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001519 | Behavior |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |