Pre-op Exercise for AIS Surgery

NCT07516574 | Enrolling By Invitation

• 1 other identifier: Pro00150871
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine if pre-operative scoliosis-specific exercises have a beneficial effect on the health outcomes of surgery for adolescent idiopathic scoliosis. Adolescent idiopathic scoliosis affects adolescents between the age of 10-18. The main questions this study aims to answer are:

• Can pre-operative exercises help reduce curve progression prior to surgery?
• Can pre-operative exercises help improve the surgery outcomes, such as a lower number of vertebrae needing fusion, increased curve correction, reduced surgery length, and shorter length of stay in the hospital?
• Can a pre-operative exercise intervention result in a reduction of the cost of surgery? Researchers will compare the current standard of care (the control group) to an intervention group (with pre-op exercises) to see if pre-op exercises have an effect on these outcomes. Participants will:
• visit the clinic every 3 months to complete ultrasound imaging scans and questionnaires
• if given an exercise intervention, aim to complete it for roughly 30 minutes a day

Conditions

Adolescent Idiopathic Scoliosis (AIS)

Keywords

Adolescent idiopathic scoliosis; AIS; scoliosis; Schroth; flexibility

Outcome Measures

Primary Outcomes (1)

• Number of levels fused

  The number of vertebrae levels fused during surgery for AIS. This is an indicator of the amount of flexibility afforded to participants post-op, their risk of adverse wear and tear on unoperated levels, and also can indicate significant cost savings to the hospital and health system.

  Indicated during surgical planning, completed during surgery (where it may change from plans)

Secondary Outcomes (14)

• Italian Spine Youth Quality of Life (ISYQOL) questionnaire

  Baseline, 3 months, 6 months, and at first routine follow-up post-surgery (6 weeks post-op)

• Spinal Appearance Questionnaire (SAQ) v1.1 Appearance score

  Baseline, 3 months, 6 months, and at first routine follow-up post-surgery (6 weeks post-op)

• Spinal Appearance Questionnaire (SAQ) v1.1 expectation score

  Baseline, 3 months, 6 months, and at first routine follow-up post-surgery (6 weeks post-op)

• Spinal Appearance Questionnaire (SAQ) v1.1 total score

  Baseline, 3 months, 6 months, and at first routine follow-up post-surgery (6 weeks post-op)

• Pre-operative flexibility measured by 3D Ultrasound Imaging

  Baseline, 3 months, and 6 months

Study Arms (2)

Standard of Care (Control)

NO INTERVENTION

The Standard of Care (Control) Group is the group that will receive the current standard of care offered in the process of treating AIS with surgery.

Pre-op Exercise Intervention

EXPERIMENTAL

The Pre-op Exercise Intervention Group will receive the current standard of care offered when treating AIS with surgery, and will also be offered the intervention by the research team that is a pre-op exercise program aimed to increase flexibility of the spine and reduce scoliosis progression.

Behavioral: Pre-op Exercise Program

Interventions

Pre-op Exercise Program BEHAVIORAL

The pre-op exercise group will complete a 6-month supervised pre-op exercise program. This program is adapted from the Schroth exercise program we tested for moderate scoliosis, showing good effect on curve angles, muscle endurance, posture, curve severity, and in self-reported pain and QOL scores. This physiotherapy will individualize exercises to specific spinal curvature(s). Exercises will focus on elongating and derotating the spine to improve the flexibility before surgery. The corrective movements required, the targeted curve type, the level of passive support involved, and the dosages recommended, have been published previously. A Schroth curve classification algorithm and algorithms to guide the prescription for the curve type will help standardize treatment. The program begins with 5 supervised visits in the first 2 weeks to help learn the exercises. The following month has supervised visits weekly and then every other week. The aim is to exercise 30mins per day 5x/week.

Pre-op Exercise Intervention

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• diagnosis of adolescent idiopathic scoliosis
• aged 10 to 18
• curve angle \>40 degrees
• waitlisted for posterior spinal fusion surgery at the Stollery Hospital

You may not qualify if:

• previous surgeries
• current use of scoliosis-specific exercises

Sponsors & Collaborators

• Eric Parent: lead
• Women and Children's Health Research Institute (WCHRI): collaborator

Study Sites (1)

Clinical Science Building, University of Alberta

Edmonton, Alberta, T6G 2R8, Canada

Location

Related Publications (2)

• Calman R, Smithers T, Rowan R. Impact of surgical waiting time on paediatric spinal deformity patients. ANZ J Surg. 2013 Dec;83(12):929-32. doi: 10.1111/ans.12196. Epub 2013 May 8.

  PMID: 23656433 BACKGROUND

• Fan Y, To MKT, Kuang GM, Lou N, Zhu F, Tao H, Li G, Yeung EHK, Cheung KMC, Cheung JPY. Five days of inpatient scoliosis-specific exercises improve preoperative spinal flexibility and facilitate curve correction of patients with rigid idiopathic scoliosis. Spine Deform. 2025 Jan;13(1):165-175. doi: 10.1007/s43390-024-00965-1. Epub 2024 Sep 26.

  PMID: 39325330 BACKGROUND

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

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

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 8, 2026
• Study Start: November 26, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-03

Locations

CA (1)