← Back to Search

Prehabilitation for Spine Surgery

N/A
Recruiting
Led By Basma Mohamed, M.D.
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Elective Lumbar or thoracolumbar Spine Fusion Surgery
Age 55 and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 3 months
Awards & highlights

Study Summary

This trial is testing whether a new pre-surgery program can help improve the outcomes of surgery for frail patients with spine problems.

Who is the study for?
This trial is for people aged 55 or older who are considered frail, with a score of 3+ on the Johns Hopkins Frailty Assessment. They must be scheduled for elective lumbar or thoracolumbar spine fusion surgery. Those with urgent cases, spine trauma, tumors, infections, severe physical limitations like amputation or paralysis, significant heart disease, cognitive issues preventing consent or participation in exercise cannot join.Check my eligibility
What is being tested?
The study tests a new prehabilitation program against standard care to see if it improves functional status before surgery and outcomes after complex spine fusion surgery in frail patients. Participants will be randomly assigned to either the novel prehabilitation method or the usual pre-surgical care.See study design
What are the potential side effects?
Since this trial involves a non-drug intervention focusing on exercise and nutrition rather than medication, side effects may include typical risks associated with physical activity such as muscle soreness or strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for elective surgery to fuse bones in my lower back.
Select...
I am 55 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
6 Minute Walk Test
Frailty Assessment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Multimodal Prehabilitation ArmExperimental Treatment1 Intervention
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.
Group II: Standard Clinical Care Comparison ArmActive Control1 Intervention
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

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,547 Total Patients Enrolled
Basma Mohamed, M.D.Principal InvestigatorUniversity of Florida

Media Library

Multimodal Prehabilitation Clinical Trial Eligibility Overview. Trial Name: NCT05034341 — N/A
Spinal Fusion Research Study Groups: Multimodal Prehabilitation Arm, Standard Clinical Care Comparison Arm
Spinal Fusion Clinical Trial 2023: Multimodal Prehabilitation Highlights & Side Effects. Trial Name: NCT05034341 — N/A
Multimodal Prehabilitation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05034341 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently being recruited for this research study?

"According to information posted on clinicaltrials.gov, this medical trial is actively recruiting patients and was last updated on May 23rd 2022 - it has been open since November 1st 2021."

Answered by AI

What criteria is necessary for an individual to be eligible for this trial?

"Candidates eligible for participation in this research trial must have undergone prehabilitation and be between 55-85 years old. Approximately 120 patients are being accepted."

Answered by AI

How many individuals are being recruited for participation in this investigation?

"Affirmative. Clinicaltrials.gov verifies that the trial, which was initiated on November 1st 2021, is still in progress and actively recruiting patients from one specific clinical site with a total of 120 needed participants."

Answered by AI

Does the requirement for this experiment exclude individuals aged 50 or fewer?

"The protocol for this clinical trial stipulates that the lower bound of age eligibility is 55 and the upper limit is 85."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Does Prehabilitation Improve Outcomes in Patients Undergoing Complex Spine Fusion Surgery?
2021. "Does Prehabilitation Improve Outcomes in Patients Undergoing Complex Spine Fusion Surgery?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05034341.
~48 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top