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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05034341
• Other study ID #: IRB202000987
• Secondary ID: OCR39834
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: January 2027

Study information

• Verified date: April 2024
• Source: University of Florida
• Contact: Basma Mohamed, M.D.
• Phone: 9524656581
• Email: bmohamed[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2027
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Multimodal Prehabilitation
In addition to Standard Clinical Care Behavioral - An exercise program focusing on aerobic exercise as well as strength training. Sessions will be supervised by a physical therapist, 2 times a week for a minimum of 6-8 weeks in addition to home exercise program. They will also participate in a single session of Cognitive-Behavioral Therapy and will receive an educational pamphlet about Pain and Neuroscience Education. Dietary Supplement - Protein supplements in the form of protein shakes at a dose of 1.2-1.5 gram per kg daily for 6-8 weeks. Protein supplements will be calculated based on ideal body weight and will be given to the patient with instructions on specific use. Diabetic patients will receive protein supplements that are sugar free.
• Standard Pre-Surgical Clinical Care
Education related to preoperative activity and home-based exercise program. Standard preoperative consultation with anesthesiology: Preoperative medical optimization and management, referral to medical specialties as deemed necessary with focus on preoperative cognitive assessment.

Locations

Country	Name	City	State
United States	UF Health of University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frailty Assessment	Johns Hopkins Frailty Assessment	Baseline up to 3 months
Primary	6 Minute Walk Test	Distance and Percent Predicted Distance Travelled by Walking for 6 Minutes and then evaluating their performance in comparison to normal population. Also, measuring the the symptoms of fatigue and severity of dyspnea on exertion	Baseline up to 3 months