Does a Pre-operative Exercise Program Improve Post-operative Outcomes for Fusion Patients

NCT06076577 | Unknown

• 1 other identifier: H22-02186
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study found that in 1744 patients undergoing fusion surgery for adolescent Idiopathic scoliosis, 12% had back pain remaining after recovering from surgery. Rehabilitation prior to spine surgery or prehabilitation (prehab), has been shown to reduce costs and improve functional outcomes in patients who have had total hip or total knee arthroplasties. There is a lack of literature looking at prehab in the context of spine surgeries. The purpose of this study is to see if prehab can improve patient outcomes such as decreased pain, decreased length of stay in the hospital, and improved functional outcomes in patients undergoing fusion surgery for adolescent idiopathic scoliosis.

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  The primary analysis for the primary outcome length of stay is to determine if the prehab program reduces the average length of stay. It will follow the intention to treat approach, which will include all randomized participants retained in the group to which they are allocated. A complete analysis will be conducted to compare the outcomes between the two arms, utilizing the Student's t test or Wilcoxon-Mann-Whitney test, as appropriate for the distribution of the data. If more than 10% of randomized participants have missing length of stay outcomes, the missing data will be imputed using the Last Observation Carried Forward approach, as a sensitivity analysis.

  2 years

Secondary Outcomes (2)

• Pain Outcome

  2 years

• Functional Outcome

  2 years

Study Arms (2)

Standard of Care Group

NO INTERVENTION

Prehabilitation Exercise Group

EXPERIMENTAL

The exercise arm participants will be asked to complete weekly questionnaires which will take around 10 minutes each week and the exercise program which takes 30 minutes each day.

Behavioral: Prehabilitation Exercise Group

Interventions

Prehabilitation Exercise Group BEHAVIORAL

A set of core stabilization exercises and scoliosis specific exercises will be given to patients.

Prehabilitation Exercise Group

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Included patients will have a diagnosis of AIS (ages 11-18). They will have a curve angle requiring surgery and be on the waitlist for surgery.

You may not qualify if:

• Patients will be excluded if they are currently enrolled in a physiotherapy designed exercise program prior to being enrolled in the study.
• They will be excluded if they have additional medical issues, limiting their ability to participate fully in the exercise program.
• Individuals with any cognitive disability that affects their ability to complete the questionnaires or follow instructions for the exercise program will also be excluded.

Sponsors & Collaborators

• University of British Columbia: lead

Central Study Contacts

Shaina Sim, BSc

CONTACT

6048752000; shaina.sim@cw.bc.ca

Firoz Miyanji, MD

CONTACT

fmiyanji@cw.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: October 11, 2023
• Study Start: November 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share