Prehabilitation for Scoliosis

Recruiting in Palo Alto (17 mi)

Overseen byDaniel Santa Mina, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Approved in 3 Jurisdictions

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.

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.

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Treatment Details

Interventions

Prehabilitation (Behavioral Intervention)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Active Control

Group I: PrehabilitationExperimental Treatment1 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 careActive Control1 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: