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

NCT04787874 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2021-12-15

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

Principal Investigators

  • Cindy Kin, MD · Asst Prof-Med Ctr Line

  • Cara Black, MD · Resident

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-21
Primary Completion
2025-05-23
Completion
2025-06-02

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04787874 on ClinicalTrials.gov