Prehab for Adult Spinal Deformity Surgery

NCT ID: NCT05452057

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2025-06-01

Brief 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

Keywords

Prehabilitation; Exercise; Stress management; Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Prehabilitation

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 Type: EXPERIMENTAL

Prehabilitation

Intervention Type: BEHAVIORAL

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.

Usual care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Candidates for spinal deformity surgery;
• recruited at least 12 weeks preoperatively;
• a frailty score of 0.27 or greater as indicated by the Modified Frailty index-11; and
• proficient in English to comprehend informed consent and intervention instructions

Exclusion Criteria

• Refusal to be randomized;
• have significant comorbidity precluding participation in prehabilitation exercises (including Canadian Cardiovascular Society class III/IV coronary disease; New York Heart Association class III/IV congestive heart failure; neurological or musculoskeletal disorder prohibiting exercise; major neuropsychiatric disorder)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Daniel Santa Mina

Clinician Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Santa Mina, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

21-5303

Identifier Type: -

Identifier Source: org_study_id