Clinical trial NCT05452057: Prehab for Adult Spinal Deformity Surgery
Official title: Prehabilitation for Adult Spinal Deformity Surgery: a Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Deformity
Keywords: Prehabilitation
Exercise
Stress management
Nutrition
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized (1:1)
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Feasibility assessment: Recruitment and Enrollment
timeFrame: 6 months
measure: Feasibility assessment: Intervention fidelity
timeFrame: pre-operative
measure: Feasibility assessment: Adherence,
timeFrame: pre-operative
measure: Feasibility assessment: Retention
timeFrame: 6 months
measure: Feasibility assessment: Safety and adverse events
timeFrame: 6 months
measure: Feasibility assessment: Cost.
timeFrame: 6 months
Secondary outcomes:
measure: Clinical outcomes: hospital length of stay
timeFrame: Post-operative
measure: Clinical outcomes: Discharge disposition
timeFrame: Post-operative
measure: Clinical outcomes: Complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Daniel Santa Mina, PhD
role: PRINCIPAL_INVESTIGATOR
References: