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

Primary Purpose

Lumbar Spine Injury, Spinal Fusion, Frailty

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multimodal Prehabilitation
Standard Pre-Surgical Clinical Care
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spine Injury focused on measuring Frailty, Prehabilitation, Perioperative Outcomes

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • UF Health of University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multimodal Prehabilitation Arm

Standard Clinical Care Comparison Arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Frailty Assessment
Johns Hopkins Frailty Assessment
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

Secondary Outcome Measures

Full Information

First Posted
September 1, 2021
Last Updated
February 28, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05034341
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Does Multimodal Prehabilitation improve frail patients' preoperative functional capacity before spine surgery? Does Multimodal Prehabilitation improve frail patients' postoperative outcomes after spine surgery? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spine Injury, Spinal Fusion, Frailty, Prehabilitation, Nutritional Supplementation, Functional Outcome
Keywords
Frailty, Prehabilitation, Perioperative Outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multimodal Prehabilitation Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Clinical Care Comparison Arm
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Multimodal Prehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Pre-Surgical Clinical Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frailty Assessment
Description
Johns Hopkins Frailty Assessment
Time Frame
Baseline up to 3 months
Title
6 Minute Walk Test
Description
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
Time Frame
Baseline up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Basma Mohamed, M.D.
Phone
9524656581
Email
bmohamed@ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Regina Knudsen, MS
Phone
352-273-6786
Email
rknudsen@anest.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Basma Mohamed, M.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health of University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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