Effect of Prehabilitation on Surgical Outcomes of Abdominally-based Plastic Surgery Procedures

NCT ID: NCT04787874

Last Updated: 2021-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-21

Study Completion Date

2025-06-02

Brief Summary

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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.

Detailed Description

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Conditions

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Ventral Hernia Panniculus Abdominoplasty Flap Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Prehabilitation Program

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Cara Black

Resident Physician, PGY-1

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cindy Kin, MD

Role: STUDY_DIRECTOR

Asst Prof-Med Ctr Line

Cara Black, MD

Role: PRINCIPAL_INVESTIGATOR

Resident

Locations

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Stanford Cancer Center South Bay

San Jose, California, United States

Site Status RECRUITING

Stanford Plastic and Reconstructive Surgery Clinic

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cara Black, PGY-2

Role: CONTACT

Phone: 650-723-7001

Email: [email protected]

Facility Contacts

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Rahim Nazerali, MD, MHS

Role: primary

Rahim Nazerali, MD, MHS

Role: primary

Other Identifiers

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60419

Identifier Type: -

Identifier Source: org_study_id