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Prehabilitation for Scoliosis

N/A

Recruiting

Led By Daniel Santa Mina, PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Candidates for spinal deformity surgery

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a multimodal prehabilitation program prior to surgery for spinal deformity in adults is feasible and has positive effects.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since prehabilitation involves exercise, nutrition, and psychological support rather than medication, side effects may include typical exercise-related discomfort or stress from lifestyle changes but are generally minimal compared to drug treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility assessment: Adherence

Feasibility assessment: Cost.

Feasibility assessment: Intervention fidelity

+3 more

Secondary study objectives

Clinical outcomes: Complications

Clinical outcomes: Discharge disposition

Clinical outcomes: hospital length of stay

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prehabilitation

2013

Completed Phase 3

~1040

0 / 1Eligibility criteria met