NCT05452057

Prehab for Adult Spinal Deformity Surgery

Prehabilitation for Adult Spinal Deformity Surgery: a Feasibility Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Spinal deformity is defined as a curvature in the spine where the alignment is outside of defined normal limits in the sagittal (e.g., kyphosis, lordosis), or coronal plane (e.g., scoliosis). The severity of symptoms among patients with spinal deformity varies and is contingent upon the type and extent of deformity. Studies have shown that adult patients with symptomatic spinal deformity have similar or worse patient-reported health-related quality of life (HRQOL) compared with other pathological conditions such as arthritis, chronic pulmonary disease, congestive heart failure, diabetes, and cancer. Over the last decade, multiple studies have demonstrated a significant improvement in patient HRQOL, disability and leg pain following spinal deformity surgery at 2-years of follow up. In contrast, patients who are treated non-surgically do not exhibit significant HRQOL changes compared to baseline. Spinal deformity surgery, however, can be associated with complications, with rates as high as 77%. Possible complications include hemorrhage, cerebrospinal fluid leak, screw malposition, ischemic optic neuropathy, thromboembolic events, cardiopulmonary complications, and infection. Recovery from surgery is long-term and challenging, with an expectation that patients may feel worse for up to 3 months after surgery. Moreover, length of hospital stay (LOS), discharge to inpatient rehabilitation, and additional post-discharge, home-care support following spinal deformity surgery are significant drivers of health care costs. In fact, LOS has been reported up to 100 days, with predictors of increased LOS including frailty and functional status. Thus, strategies that can improve preoperative functional status, and subsequently reduce postoperative LOS and improve postoperative recovery trajectories are important for adults undergoing surgery for spinal deformity.

Conditions

• Spinal Deformity

Interventions

Type	Name	Description
BEHAVIORAL	Prehabilitation	A Registered Kinesiologist will provide your exercise prescription during your first visit for the study. Your exercise sessions will consist of moderate-intensity cardiovascular (or aerobic) exercise, like brisk walking, for 30 minutes. You will also perform resistance exercises (weight lifting) for 30 minutes that will help strengthen your muscles with a focus on muscles that may be affected by your surgery. To complete your exercises, you will receive resistance bands, exercise ball, and exercise manual. You will also meet with a Registered Dietician within a week of consent to receive information on healthy eating and you will receive protein to improve your nutritional health. A consult with an expert in psychology to discuss ways to reduce your stress within a week of consent. Some strategies to help reduce your stress may include breathing exercises, being mindful, or other relaxation methods.

Timeline

• Start date: 2022-11-03
• Primary completion: 2024-10-17
• Completion: 2024-10-17
• First posted: 2022-07-11
• Last updated: 2026-03-12

Locations

1 site across 1 country: Canada