Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923672
Status:
TERMINATED
Last Update Posted:
2023-08-04
First Post:
2021-06-07
Brief Title:
Exercise Preconditioning with Cancer Surgeries
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Evaluation of the Feasibility of Wearable Technology-Guided Exercise Preconditioning to Accelerate Return to Function After Cancer Surgery
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company providing the computer application for exercise intervention suddenly closed for business
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ExPre 01
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
Optional Participants will also be asked to provide a small amount of blood for research purposes
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
Optional Participants will also be asked to provide a small amount of blood for research purposes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None