Prehabilitation for Scoliosis

Overseen By Daniel Sibley, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Coronary disease, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

Trial Summary

What is the purpose of this trial?

Prehabilitation is defined as the process of enhancing patients' functional capacity and overall fitness to enable them to withstand a forthcoming stressor (e.g. surgery). Although there are different models of prehabilitation, multimodal prehabilitation is recommended to address the physical and psychological health outcomes prior to surgery. Multimodal prehabilitation commonly consists of exercise-training, nutritional, and psychological support. Evidence suggests that prehabilitation improves preoperative physical fitness and reduces postoperative complications and length of stay in patients undergoing major abdominal surgery. However, the evidence for the feasibility and effects in spinal deformity surgery are less understood. This study is a two arm, pilot randomized controlled trial to assess the feasibility of a multimodal prehabilitation program prior to surgery for spinal deformity in adults. Participant outcomes will be measured using standardized fitness testing, self-report questionnaires, and medical record reviews at baseline, one week preoperatively, and at 30 days postoperatively.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Prehabilitation for Scoliosis?

Research shows that a preoperative protocol of aerobic physical therapy can improve the quality of life for patients with adolescent idiopathic scoliosis, as seen in a study where patients who underwent this therapy had significant improvements in quality of life scores compared to those who did not. ^{1 2 3 4 5}

Is prehabilitation safe for humans?

Prehabilitation, which includes monitored physical activities and aerobic exercise, has been shown to improve physical performance and quality of life in patients with scoliosis, suggesting it is generally safe for humans. ^{2 6 7 8 9}

How is the treatment Prehabilitation for Scoliosis different from other treatments for this condition?

Prehabilitation for scoliosis is unique because it focuses on improving a patient's physical condition before surgery through a combination of aerobic exercises, strength training, and functional task training. This approach aims to enhance the patient's ability to maintain normal function during and after surgery, potentially improving quality of life and reducing recovery time. ^{1 2 10 11 12}

Research Team

Daniel Santa Mina, PhD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for adults scheduled for spinal deformity surgery in at least 12 weeks, with a certain level of frailty as measured by the Modified Frailty Index. Participants must understand English to follow consent and instructions.

Inclusion Criteria

I joined the study more than 12 weeks before my scheduled surgery.

You have a frailty score of 0.27 or higher based on a specific test called the Modified Frailty index-11.

I am a candidate for surgery to correct a spinal deformity.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a multimodal prehabilitation program including exercise, nutrition, and psychological support to enhance functional capacity before surgery.

6 months

Weekly consultations (in-person or virtual)

Surgery

Participants undergo spinal deformity surgery.

1 day

Postoperative Follow-up

Participants are monitored for safety, effectiveness, and complications after surgery.

6 months

Regular follow-up visits (in-person or virtual)

Treatment Details

Interventions

• Prehabilitation

Trial Overview The study tests a multimodal prehabilitation program designed to boost patients' fitness and mental readiness before spine surgery. It's a pilot trial comparing two groups: one receiving this special preparation and another not, measuring outcomes like fitness levels and recovery.

Participant Groups

Group I: Prehabilitation Experimental Treatment 1 Intervention

This will include an individualized, light to moderate intensity resistance training and aerobic exercise components. Each prescribed session will include: a minute warm-up, aerobic exercise, resistance training, and a cool-down, but may be modified to accommodate the participants exercise ability. A registered dietitian will provide an individualized nutrition assessment and counselling session within the first week of prehabilitation and again in the week prior to surgery. A staff psychologist or psychology resident will deliver a \~60-minute psychoeducation session that focuses on stress management via relaxation, mindfulness, goal setting, and strategies to overcoming barriers to practice. In the week prior to surgery, participants will be offered a second consultation with the psychology team member to review their stress management experiences and provide further support for the acute perioperative period.

Group II: Usual care Active Control 1 Intervention

Usual care group will be asked to resume your typical lifestyle behaviours until the date of the surgery and will be provided with publicly available resources on physical activity, diet, and stress management.

Prehabilitation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Approved in United States as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Approved in Canada as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

In a study of 74 adolescents with idiopathic scoliosis, those who participated in the Scientific Exercises Approach to Scoliosis (SEAS) had a significantly lower rate of brace prescriptions (6.1%) compared to those receiving usual care (25.0%).

The SEAS exercises not only reduced the need for bracing but also led to improvements in Cobb angle measurements, with 23.5% of patients improving, while the usual physiotherapy group saw a worsening in their Cobb angles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specific exercises reduce brace prescription in adolescent idiopathic scoliosis: a prospective controlled cohort study with worst-case analysis. Negrini, S., Zaina, F., Romano, M., et al.[2022]

In a study of 466 patients with adolescent idiopathic scoliosis, the reoperation rates after spinal deformity surgery varied by technique, ranging from 4.5% for open anterior spinal fusion to 8.8% for posterior spinal fusion with hooks, indicating that while reoperations are necessary, they occur at relatively low rates.

The study identified common serious radiographic adverse events, such as rod breakage and proximal screw pullout, but found no significant differences in the incidence of these events across different surgical techniques, suggesting that all methods have similar safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiographic classification of complications of instrumentation in adolescent idiopathic scoliosis. Flynn, JM., Betz, RR., O'Brien, MF., et al.[2021]

A systematic review of 33 studies involving 3167 citations found that prehabilitation did not significantly improve postoperative function, quality of life, or pain in patients undergoing knee or hip arthroplasty for osteoarthritis.

However, prehabilitation programs lasting over 500 minutes may reduce the need for postoperative rehabilitation, indicating a potential benefit in healthcare utilization, even though no significant reductions in readmissions or nursing home placements were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of prehabilitation or preoperative exercise for surgical patients: a systematic review. Cabilan, CJ., Hines, S., Munday, J.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Prehabilitation and early rehabilitation after spinal surgery: randomized clinical trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of a preoperative protocol of aerobic physical therapy on the quality of life of patients with adolescent idiopathic scoliosis: a randomized clinical study. [2022]

3. Sweden pubmed.ncbi.nlm.nih.gov

Specific exercises reduce brace prescription in adolescent idiopathic scoliosis: a prospective controlled cohort study with worst-case analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Corrective exercise-based therapy for adolescent idiopathic scoliosis: Systematic review and meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Enhancing Idiopathic Scoliosis Patients' Outcomes Through Functional Rehabilitation Training in Combination with Orthosis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Review of Physical Activity Benefits and Potential Considerations for Individuals with Surgical Fusion of Spine for Scoliosis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Risk factors affecting the immediate postoperative course in pediatric scoliosis surgery. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Radiographic classification of complications of instrumentation in adolescent idiopathic scoliosis. [2021]

9. Spain pubmed.ncbi.nlm.nih.gov

Long-term impact of pre-operative physical rehabilitation protocol on the 6-min walk test of patients with adolescent idiopathic scoliosis: A randomized clinical trial. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

Sports participation reduces the progression of idiopathic scoliosis and the need for bracing. An observational study of 511 adolescents with Risser 0-2 maturation stage. [2023]

11. Australia pubmed.ncbi.nlm.nih.gov

The effectiveness of prehabilitation or preoperative exercise for surgical patients: a systematic review. [2022]

12. England pubmed.ncbi.nlm.nih.gov

PROPER-PRehabilitatiOn Plus Enhanced Recovery after surgery versus enhanced recovery after surgery in gynecologic oncology: a randomized clinical trial. [2022]