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

NCT05034341 | Terminated DMC

• 2 other identifiers: IRB202000987OCR39834
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spine Injury; Spinal Fusion; Frailty; Prehabilitation; Nutritional Supplementation; Functional Outcome

Keywords

Frailty; Prehabilitation; Perioperative Outcomes

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Multimodal Prehabilitation Arm

EXPERIMENTAL

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

Standard Clinical Care Comparison Arm

ACTIVE COMPARATOR

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

Interventions

Multimodal Prehabilitation OTHER

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.

Multimodal Prehabilitation Arm

Standard Pre-Surgical Clinical Care OTHER

* 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.

Standard Clinical Care Comparison Arm

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health of University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Spinal Injuries; Frailty

Condition Hierarchy (Ancestors)

Back Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Basma Mohamed, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 5, 2021
• Study Start: November 1, 2021
• Primary Completion: May 8, 2024
• Study Completion: May 8, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

US (1)