Clinical trial NCT05034341: Does Prehabilitation Improve Outcomes in Patients Undergoing Complex Spine Fusion Surgery?
Official title: Does Prehabilitation Improve Outcomes in Patients Undergoing Complex Spine Fusion Surgery?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lumbar Spine Injury
Spinal Fusion
Frailty
Prehabilitation
Nutritional Supplementation
Functional Outcome
Keywords: Frailty
Prehabilitation
Perioperative Outcomes
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 10
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Frailty score of 3 or more (based on Johns Hopkins Frailty Assessment).
* Age 55 and older
* Elective Lumbar or thoracolumbar Spine Fusion Surgery

Exclusion Criteria:

* Emergency surgery
* Time-sensitive surgery
* Spine trauma, tumor, or infection
* Physical condition that limits exercise: Lower extremity amputation, hemiplegia or hemiparesis, stroke with residual weakness, symptomatic severe cardiac disease (for example: severe aortic stenosis, unstable angina)
* Patient refusal
* Severe cognitive dysfunction preventing participation or consenting.

Primary outcomes:
measure: Frailty Assessment
timeFrame: Baseline up to 3 months
measure: 6 Minute Walk Test
timeFrame: Baseline up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health of University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Basma Mohamed, M.D.
role: PRINCIPAL_INVESTIGATOR
References: