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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a program called prehabilitation can better prepare individuals for spine surgery. Prehabilitation includes exercises, nutrition counseling, and stress management support to enhance fitness and mental readiness before the operation. The trial compares this approach to standard care, where participants maintain their usual habits. It suits those planning spinal deformity surgery who can begin the program at least 12 weeks prior and understand English instructions. Participants should exhibit a certain level of frailty that impacts their daily life. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve surgical outcomes for future patients.

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 prior data suggests that this prehabilitation program is safe for adults undergoing spinal deformity surgery?

Research shows that prehabilitation is generally safe for people preparing for spine surgery. In past studies, prehabilitation improved physical fitness and mental well-being before surgery. This program usually includes exercise, nutrition advice, and stress management.

One study found that prehabilitation significantly increased muscle strength and improved quality of life before surgery. Another study showed it reduced complications after surgery, leading to fewer health issues during recovery.

Studies do not specifically mention serious side effects, suggesting that prehabilitation is well-tolerated. The exercises and support are often personalized, allowing adjustments if any discomfort occurs.

Overall, prehabilitation appears to be a safe and helpful option for those preparing for spine surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about prehabilitation for scoliosis because it takes a holistic approach to prepare patients for surgery. Unlike traditional care, which often focuses solely on post-surgical recovery, prehabilitation includes exercise, nutrition, and stress management before surgery. This method aims to enhance overall health, potentially leading to better surgical outcomes and a faster recovery. By addressing physical, nutritional, and psychological aspects, prehabilitation offers a comprehensive strategy that could transform how scoliosis surgeries are approached.

What evidence suggests that prehabilitation might be an effective treatment for scoliosis?

Research shows that prehabilitation, which participants in this trial may receive, can help patients prepare for surgery by boosting their physical and mental health. It strengthens patients before surgery and reduces the risk of complications and long hospital stays, especially for major surgeries. However, evidence remains limited for spine surgeries, such as those for scoliosis. Some studies found no significant differences in outcomes, like hospital stay and readmission rates, for spine surgery patients who underwent prehabilitation. More research is needed to understand its effectiveness for scoliosis surgery. ^{4 6 7 8 9}

Who Is on the Research Team?

Daniel Santa Mina, PhD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39906431/

Effectiveness of Prehabilitation Programs in Reducing the ... Data were synthesized from meta-analyses and systematic reviews to assess the effectiveness of uni- and multimodal prehabilitation interventions ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0303846725003178

The association between prehabilitation participation and ... The effect of prehabilitation on spine surgery outcomes was investigated. · No significant differences in stay, discharge, ED visits, or readmission rates.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7882827/

Perioperative Optimization of Patients With Neuromuscular ... Below is our institutional pathway for the optimization of patients undergoing surgery for neuromuscular scoliosis (Figure 1). This pathway has been developed ...

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/10538127251346600

The impact of prehabilitation on postoperative outcomes in ... Prehabilitation aims to optimize patients' physical and psychological status before spine surgery to enhance recovery.

5. withpower.com withpower.com/trial/phase-spinal-deformities-2-2022-5758a

Prehabilitation for Scoliosis · Info for Participants Participant outcomes will be measured using standardized fitness testing, self-report questionnaires, and medical record reviews at baseline, one week ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12029390/

Comprehensive guidelines for prehabilitation in spine surgery Targeting patient risk factors with personalized interventions can improve postoperative outcomes in patients undergoing elective spine surgery.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1040738325000280

Preoperative optimization and patient preparations for ... This review summarizes the current literature on different preoperative strategies to improve patient outcomes after spine surgery.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10726416/

Impact of preoperative uni- or multimodal prehabilitation on ... Postoperative complications occur in up to 43% of patients after surgery, resulting in increased morbidity and economic burden.

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2803788

Prehabilitation for Patients Undergoing Orthopedic Surgery The prehabilitation intervention significantly improved function, health-related quality of life, muscle strength, and back pain prior to surgery.