Recruiting

Prehabilitation

Sponsor:

Stanford University

Code:

NCT04787874

Conditions

Ventral Hernia

Panniculus

Abdominoplasty

Flap Reconstruction

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Interventions

Prehabilitation Program

Study Details

Brief summary:

The purpose of this study is to determine whether a program to optimize patient physical fitness and nutrition ("prehabilitation") prior to and after plastic surgery involving the abdomen improves surgical outcomes. The investigators hope to determine how a multimodal peri-operative prehabilitation program can be most effective in engaging and motivating patients to physically and mentally get ready for an abdominally-based plastic surgery operation. The overall goal is to determine if this program will improve post-operative recovery after abdominally-based plastic surgery. The importance of this new knowledge is better understanding of ways that plastic surgeons can improve outcomes, engagement, and experience of patients undergoing abdominally-based plastic surgery operations. This would translate to increased healthcare value and better long-term outcomes.

Conditions

Ventral Hernia

Panniculus

Abdominoplasty

Flap Reconstruction

Study ID

NCT04787874

Start date

Jun 21, 2021

Status verified date

Dec, 2021

Completion date

Jun 2, 2025

Anticipated

Primary completion date

May 23, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Inclusion Criteria:

- Adult patients (>18 years) who are undergoing elective abdominally-based plastic surgery operations in 3+ weeks by one of the following plastic surgeons: Nazerali, Lee, Murphy, Nguyen, Lorenz.

Exclusion Criteria:

  • Patients who do not speak English
  • Patients who do not have access to a smartphone or internet/cell service.
  • Patients who are undergoing another intervention study that consists of a nutrition and/or exercise behavior change.

Study Design

Enrollment

520 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

The control arm will receive no additional prehabilitation material prior to material. Rather, they will receive standard preoperative care in which they will be given standard advice on nutrition and fitness. REDcap surveys will be administered.

experimental: Prehab Intervention Arm

The intervention arm will receive access to the prehab program (abdominal workout videos) and surveys via RedCAP.The program will start no less than 14 days before the date of surgery.

Interventions

Prehabilitation Program

Nutrition component: Participants will receive information on how to follow a healthy diet (Mediterranean-style diet) with emphasis on whole foods, plants, lean protein, olive oil; restriction of red meats, processed meats, processed foods, added sugar)

Exercise component: Participants will receive an activity tracker to use during the study period (3+ weeks before surgery, and 30 days after surgery). Participants will be assigned strength exercises to work on core strength and proximal muscle strength (biceps/triceps, quads, hamstrings, calves).The exercises will mainly be focused on strengthening the abdominal wall. Exercises will be tailored to patients' individual capabilities. They will also be assigned cardio exercises - either low-intensity steady state cardio vs High Intensity Interval training. Level of cardio exercise will be tailored based on patient's Duke Activity score and baseline activity.

Primary outcome measure

  • Occurrence of surgical complications (Post-op days 7-14) [ Time Frame: Post-operative days 7-14 ]
  • Occurrence of surgical complications (Post-op day 30) [ Time Frame: Post-operative day 30 ]
  • Occurrence of surgical complications (Post-op day 90) [ Time Frame: Post-operative day 90 ]
  • Occurrence of surgical complications (Post-op day 180) [ Time Frame: Post-operative day 180 ]
  • Occurrence of surgical complications (Post-op day 360) [ Time Frame: Post-operative day 360 ]
  • Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op days 7-14 [ Time Frame: Post-operative days 7-14 ]
  • Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op days 7-14 [ Time Frame: Post-operative days 7-14 ]
  • Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 30 [ Time Frame: Post-operative day 30 ]
  • Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op day 30 [ Time Frame: Post-operative day 30 ]
  • Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 90 [ Time Frame: Post-operative day 90 ]
  • Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op day 90 [ Time Frame: Post-operative day 90 ]
  • Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 180 [ Time Frame: Post-operative day 180 ]
  • Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op day 180 [ Time Frame: Post-operative day 180 ]
  • Patient-Reported Outcome Measures: RAND 36-Item Health Survey (RAND-36) on Post-op day 360 [ Time Frame: Post-operative day 360 ]
  • Patient-Reported Outcome Measures: Abdominal Surgery Impact Scale (ASIS) on Post-op day 360 [ Time Frame: Post-operative day 360 ]
  • Physical Function Test: 6-minute walk test at Time of Enrollment [ Time Frame: Time of enrollment ]
  • Physical Function Test: 5-times-sit-to-stand test at Time of Enrollment [ Time Frame: Time of enrollment ]
  • Physical Function Test: Timed-up-and-go test at Time of Enrollment [ Time Frame: Time of enrollment ]
  • Physical Function Test: 6-minute walk test at 3 weeks [ Time Frame: 3 weeks ]
  • Physical Function Test: 5-times-sit-to-stand test at 3 weeks [ Time Frame: 3 weeks ]
  • Physical Function Test: Timed-up-and-go test at 3 weeks [ Time Frame: 3 weeks ]
  • Physical Function Test: 6-minute walk test on Post-op Day 30 [ Time Frame: Post-operative day 30 ]
  • Physical Function Test: 5-times-sit-to-stand-test on Post-op Day 30 [ Time Frame: Post-operative day 30 ]
  • Physical Function Test: Timed-up-and-go test on Post-op Day 30 [ Time Frame: Post-operative day 30 ]
  • Physical Function Test: 6-minute walk test on Post-op Day 90 [ Time Frame: Post-operative day 90 ]
  • Physical Function Test: 5-times-sit-to-stand test on Post-op Day 90 [ Time Frame: Post-operative day 90 ]
  • Physical Function Test: Timed-up-and-go test on Post-op Day 90 [ Time Frame: Post-operative day 90 ]

Central Contacts and Locations

Central contacts

Cara Black, PGY-2

650-723-7001carablack@stanford.edu

Locations

Stanford Cancer Center South Bay

Recruiting

San Jose, California, United States, 95124

Stanford Plastic and Reconstructive Surgery Clinic

Recruiting

Stanford, California, United States, 94304

More Information

Sponsor

Stanford University

Last update posted

Dec 15, 2021

Last verified

Dec, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2021-12-15.