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

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.

Study Overview

• Status: Terminated
• Conditions: Frailty; Spinal Fusion; Prehabilitation; Lumbar Spine Injury; Nutritional Supplementation; Functional Outcome
• Intervention / Treatment: Other: Multimodal Prehabilitation; Other: Standard Pre-Surgical Clinical Care

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health of University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal Prehabilitation Arm; The Multimodal Prehabilitation group will receive: 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 a home exercise program. Patients' compliance will be monitored by phone each week.; 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.; Pain and Neuroscience Education: Per University of Florida Health Pain and Neuroscience program at Shands hospital.; Standard Clinical Care: Preoperative medical optimization and management, referral to medical specialties as deemed necessary with a focus on preoperative cognitive assessment.	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.
Active Comparator: Standard Clinical Care Comparison Arm; The Standard Clinical Care Comparison group will receive: 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.; A final preoperative visit before surgery where a second set of functional assessment will be implemented	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty Assessment	Johns Hopkins Frailty Assessment	Baseline up to 3 months
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

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Basma Mohamed, M.D., University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): May 8, 2024
• Study Completion (Actual): May 8, 2024

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Perioperative Outcomes; Frailty; Prehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Back Injuries; Frailty; Spinal Injuries
• Other Study ID Numbers: IRB202000987; OCR39834 (Other Identifier: UF OnCore)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No