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

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prehabilitation Exercise Group
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adolescent Idiopathic Scoliosis

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard of Care Group

    Prehabilitation Exercise Group

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Pain Outcome
    The pain outcomes will be measured using the Visual Analogue Scale (VAS); a scale ranging from 0 - 10, where 0 indicates no pain, and 10 indicates extreme pain.
    Functional Outcome
    The functional outcomes will be measured using the Scoliosis Research Society 22-item questionnaire (SRS-22). In this questionnaire, responses correspond to numbers 1 - 5, where 1 is the worst possible outcome and 5 is the best possible outcome. There will be a total SRS-22 score (average of all the scores) and five sub scores. The sub scores will be divided into five groups: function, pain, self-image, mental health, and satisfaction with management. Answers to questions relating to these categories will be averaged for each sub score.

    Full Information

    First Posted
    April 24, 2023
    Last Updated
    October 6, 2023
    Sponsor
    University of British Columbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06076577
    Brief Title
    Does a Pre-operative Exercise Program Improve Post-operative Outcomes for Fusion Patients
    Official Title
    Does a Pre-operative Exercise Program Improve Post-operative Outcomes in Patients Undergoing Spinal Fusion Surgery for Adolescent Idiopathic Scoliosis?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2025 (Anticipated)
    Study Completion Date
    December 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of British Columbia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adolescent Idiopathic Scoliosis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    104 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard of Care Group
    Arm Type
    No Intervention
    Arm Title
    Prehabilitation Exercise Group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Prehabilitation Exercise Group
    Intervention Description
    A set of core stabilization exercises and scoliosis specific exercises will be given to patients.
    Primary Outcome Measure Information:
    Title
    Primary Outcome
    Description
    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.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Pain Outcome
    Description
    The pain outcomes will be measured using the Visual Analogue Scale (VAS); a scale ranging from 0 - 10, where 0 indicates no pain, and 10 indicates extreme pain.
    Time Frame
    2 years
    Title
    Functional Outcome
    Description
    The functional outcomes will be measured using the Scoliosis Research Society 22-item questionnaire (SRS-22). In this questionnaire, responses correspond to numbers 1 - 5, where 1 is the worst possible outcome and 5 is the best possible outcome. There will be a total SRS-22 score (average of all the scores) and five sub scores. The sub scores will be divided into five groups: function, pain, self-image, mental health, and satisfaction with management. Answers to questions relating to these categories will be averaged for each sub score.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shaina Sim, BSc
    Phone
    6048752000
    Ext
    2359
    Email
    shaina.sim@cw.bc.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Firoz Miyanji, MD
    Email
    fmiyanji@cw.bc.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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