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

NCT ID: NCT06076577

Last Updated: 2023-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Adolescent idiopathic scoliosis (AIS) is the most common spinal deformity in adolescents and literature suggests that the link between back pain and AIS is underreported. Core stabilization exercises and scoliosis specific exercises have been shown to increase SRS scores related to pain (higher SRS scores indicate lower levels of pain). Additionally, higher SRS scores at pre-op were associated with a lower risk of residual postoperative pain following a fusion surgery. This suggests that preoperative exercise programs should lead to an increase in SRS pain scores post-operatively however, this direct relationship has not been researched. Rehabilitation exercises prior to surgery has been shown to improve functional outcomes in knee and hip arthroplasties however, the rehabilitation preoperatively has not been studies in the context of spine surgeries. The purpose of this study is to evaluate whether the prehabilitation exercise program can improve post-op outcomes including length of stay, decreased pain, decreased length of stay, and improved functional outcomes.

Conditions

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Adolescent Idiopathic Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard of Care Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Prehabilitation Exercise Group

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.

Group Type EXPERIMENTAL

Prehabilitation Exercise Group

Intervention Type BEHAVIORAL

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

Interventions

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Prehabilitation Exercise Group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Firoz Miyanji

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Shaina Sim, BSc

Role: CONTACT

6048752000 ext. 2359

Firoz Miyanji, MD

Role: CONTACT

Other Identifiers

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H22-02186

Identifier Type: -

Identifier Source: org_study_id

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