Influence of Pre-operative Back Muscle Exercise on Post-operative Outcomes After Spine Surgery

The purpose of this research study is to gather more information about how improving back muscle function before surgery might influence what happens to the spine and function after surgery. This may assist in developing ways to improve surgical outcomes and determine the benefit of pre-operative exercise, if any.

Study Overview

• Status: Enrolling by invitation
• Conditions: Spine Surgery; Spine Pain
• Intervention / Treatment: Behavioral: Preoperative Resistance Exercise

Detailed Description

The investigators intend to enroll patients from UCSD spine clinic. The investigators will include patients who are indicated for a spine surgery. Once participants are identified to be surgical candidates, and have an estimated surgical date that is 4-6 weeks from identification, the participants may undergo pre-operative procedures including a pre-operative evaluation and treatment by a physical therapist, data collection (demographics, medical history, etc.), and filling out relevant questionnaires. Patients will undergo their surgery as scheduled with the spine surgeon as part of their planned standard care unless the surgeon decides that the surgery is no longer necessary. Participation in research does not influence the surgeon's decision. Post-operatively, participants may be asked to undergo a post-operative evaluation and fill out questionnaires.

Upon identification of eligibility, participants may be randomized to one of two study arms using a random number generator. If group characteristics are observed to be unbalanced using this approach, participants may be matched according to demographic or surgical features:

1. Pre-habilitation treatment arm
2. Standard of Care arm Participants in the standard of care arm will undergo all pre-operative activities recommended by their surgeon as per standard care.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • UC San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• - Individuals undergoing spinal surgery
• Individuals who have been deemed medically safe to participate in an exercise-based physical therapy program

Exclusion Criteria:

• - Individuals with comorbid conditions or spinal injury inappropriate for participating in an exercise-based physical therapy program as determined by the surgeon (e.g. unstable vertebral fracture)
• Individuals that do not have the ability to commit to the therapy schedule either in-clinic or using the web-based interface
• Non-english speaking individuals (some questionnaires are validated only in English)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control/Standard of Care; Standard of Care preoperatively per surgeon recommendation
Experimental: Preoperative Resistance exercise; Resistance based exercise targeting the back muscles above where the intended surgery is planned	Behavioral: Preoperative Resistance Exercise; Participants will have been deemed to be medically safe to participate in exercise-based physical therapy based on their physician recommendation and may also undergo an in-person evaluation by a licensed physical therapist to evaluate their physical capacity. This will inform the frequency and intensity of exercise prescription according to a participant's identified physical impairments and activity tolerance levels. Based on this information, an exercise program will be implemented either via web-based HIPAA compliant platforms (e.g. Zoom or WebEx) or in the clinic(e.g if the participant does not have internet access) on a 1-2x/week basis for the 4-6 week pre-operative duration. Each exercise session will be approximately 30 minutes. During these sessions, exercises including gravity-assisted, body-weighted, or body-weight-augmented resistance exercises targeting the paraspinal extensor muscles (multifidus, erector spinae, latissimus dorsi, lower trapezius) will be performed at a mo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Revision	Patient requires surgical revision within 1 year of index surgery	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Postoperative hospital length of stay	3 months
Numeric Pain Rating Scale	Numeric Pain Rating Scale for back and leg pain on a 0-10 scale, with 10 being worst pain imaginable and 0 being no pain	1 year
Disability	Oswestry Disability Index, in percent, from 0-100. 0 indicating 0% disabled from back pain, and 100% indicating complete disability due to back pain.	1 year

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2035

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): February 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Prehabilitation
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: 803198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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