Does Prehabilitation Improve Outcomes in Patients Undergoing Complex Spine Fusion Surgery?

Frailty Clinical Trial

Official title: Does Prehabilitation Improve Outcomes in Patients Undergoing Complex Spine Fusion Surgery?

Status Terminated

Clinical Trial Summary

A novel prehabilitation method has been implemented at our institution to decrease perioperative outcome complications for frail complex spine fusion surgery patients. The goal of this randomized trial is to evaluate whether this prehabilitation program improves preoperative functional status of frail spine disease patients and benefits patients in their postsurgical outcomes.

Clinical Trial Description

Background:

Patients with degenerative lumbar spine disease who are candidates for spine surgery may experience multiple adverse effects from the prolonged conservative and non-operative management of chronic low back pain. Due to the aging population, there is an increased demand for lumbar spine surgery in the geriatric population. At the time these patients are candidates for surgery, they might encounter the results of the conservative management including disabling pain, catastrophizing, and Kinesiophobia. The chronicity of the spine condition and the associated pain may result in functional disability, poor nutrition, and poor pain management, all of which may result in a multisystemic impact on their overall health in the form of frailty. Prehabilitation has been studied in the past to evaluate its impact on the postoperative outcomes for patients scheduled for abdominal surgery, cardiac surgery, and thoracic surgery. Currently, there are a few trials evaluating the impact of prehabilitation in spine surgery. However, there are limited data on the impact of prehabilitation on frail geriatric patients undergoing spine surgery and whether prehabilitation will impact frail patients' preoperative and postoperative functional recovery and pain management.

Based on the current literature, the investigator will hypothesize that prehabilitation will improve frail geriatric patients' preoperative and postoperative functional capacity as assessed by a six-minute walk test and will minimize the incidence of postoperative complications. In addition, the investigator will also hypothesize that prehabilitation in the form of a multimodal approach (physical exercise, nutritional, pain, and neuroscience education) will increase the chances of discharge to home in the postoperative setting, and as a result will lead to a decrease overall healthcare expenditure and total costs.

Specific Aims:

1. Does Multimodal Prehabilitation improve frail patients' preoperative functional capacity before spine surgery?

2. Does Multimodal Prehabilitation improve frail patients' postoperative outcomes after spine surgery?

3. Does Multimodal Prehabilitation improve frail patients' postoperative functional capacity after spine surgery?

The investigator will hypothesize that Multimodal Prehabilitation (physical, nutritional, and cognitive) improves frailty, functional capacity, and perioperative outcomes after spine surgery. ;

Related Conditions & MeSH terms

• Frailty
• Functional Outcome
• Lumbar Spine Injury
• Nutritional Supplementation
• Prehabilitation
• Spinal Fusion
• Spinal Injuries

• NCT number: NCT05034341
• Study type: Interventional
• Source: University of Florida
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2021
• Completion date: May 8, 2024