Complication of Surgical Procedure
Conditions
Keywords
prehabilitation, exercise, nutrition
Brief summary
This is a randomized controlled trial examining the effect of a motivational interview and perioperative mobile-app based nutrition and exercise intervention on surgical outcomes. The hypothesis is that such an intervention will improve surgical outcomes. Patients who are planned to undergo major elective abdominal surgery will be randomized to standard care or the nutrition/exercise intervention. This intervention consists of a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery.
Interventions
BEHAVIORALPOWER
This intervention consists of a motivational interview and a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* major abdominal surgery in 3+ weeks * English or Spanish speaking
Exclusion criteria
* Unable to use smartphone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Complications occurring in the 90 day post-operative period, measured by the comprehensive complication index | 90 days after surgery | The comprehensive complication index is an integrated score from 0 to 100 of all complications occurring in a specified time period and their severities as categorized by Clavien-Dindo classification. Calculation of the CCI is via a web-based calculator (www.assessurgery.com). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6 minute walk test | It will take about 6 minutes to assess, and this will be performed at enrollment, right before surgery, and at 30 and 90 days after surgery | Participants will be asked to walk as fast they can for 6 minutes using a validated mobile application (Timed Walk) to measure the distance walked. |
Countries
United States
Outcome results
None listed