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

NCT06808022 | Enrolling By Invitation DMC

• 1 other identifier: 803198
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spine Pain; Spine Surgery

Keywords

Prehabilitation; Exercise

Outcome Measures

Primary Outcomes (1)

• Surgical Revision

  Patient requires surgical revision within 1 year of index surgery

  1 year

Secondary Outcomes (3)

• Length of stay

  3 months

• Numeric Pain Rating Scale

  1 year

• Disability

  1 year

Study Arms (2)

Control/Standard of Care

NO INTERVENTION

Standard of Care preoperatively per surgeon recommendation

Preoperative Resistance exercise

EXPERIMENTAL

Resistance based exercise targeting the back muscles above where the intended surgery is planned

Behavioral: Preoperative Resistance Exercise

Interventions

Preoperative Resistance Exercise BEHAVIORAL

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

Preoperative Resistance exercise

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: February 1, 2024
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2035
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)