Prehabilitation for Spinal Deformities

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University Health Network, Toronto, Canada
Spinal Deformities+1 More
Prehabilitation - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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.

Eligible Conditions

  • Spinal Deformities

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 3 Secondary · Reporting Duration: 6 months

6 months
Clinical outcomes: Complications
Feasibility assessment: Cost.
Feasibility assessment: Recruitment and Enrollment
Feasibility assessment: Retention
Feasibility assessment: Safety and adverse events
Post-operative
Clinical outcomes: Discharge disposition
Clinical outcomes: hospital length of stay
pre-operative
Feasibility assessment: Adherence
Feasibility assessment: Intervention fidelity

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Usual care
1 of 2
Prehabilitation
1 of 2
Active Control
Experimental Treatment

24 Total Participants · 2 Treatment Groups

Primary Treatment: Prehabilitation · No Placebo Group · N/A

Prehabilitation
Behavioral
Experimental Group · 1 Intervention: Prehabilitation · Intervention Types: Behavioral
Usual careNoIntervention Group · 1 Intervention: Usual care · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prehabilitation
2013
N/A
~850

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Trial Background

Daniel Santa Mina, Clinician Scientist
Principal Investigator
University Health Network, Toronto
Closest Location: University Health Network · Toronto, Canada
Photo of Toronto  1Photo of Toronto  2Photo of Toronto  3
2005First Recorded Clinical Trial
1 TrialsResearching Spinal Deformities
273 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a frailty score of 0.27 or greater as indicated by the Modified Frailty index-11.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.