Background: Four out of ten older people having surgery live with frailty, leaving them
vulnerable to adverse outcomes due to accumulation of age- and disease-related deficits.
An increasing number of people with frailty require surgery. Frailty is associated with a
>2-fold increase in complications and new patient-reported disability; absolute rates are
>50% and 20% respectively; physical and physiologic deficits are particularly implicated.
Mortality, costs and institutionalization after surgery are also significantly associated
with frailty.
Despite frailty's strong association with adverse outcomes, few perioperative trials
include older people with frailty. Exercise therapy may improve function and decrease
complications for other people with frailty by addressing physical and physiologic
deficits. However, existing trials are small (median n=54) and single center. Most
interventions have been resource-intensive, requiring attendance at hospital-based
sessions, which may limit access to many who could benefit. Patient-reported outcomes are
also lacking. Therefore, a multicenter trial of home-based exercise therapy before
surgery for older people with frailty, powered to address patient-reported outcomes, is
needed. Our trial will address these knowledge gaps by testing the effectiveness of
home-based preoperative exercise (exercise prehabilitation) in decreasing
patient-reported disability and postoperative complications in older people with frailty
having major surgery.
Research aims: Estimate the effectiveness of exercise prehabilitation on:
Co-primary outcomes: patient-reported disability 30-days after surgery and
in-hospital complications
Secondary outcomes: patient-centered (discharge home, survival, 30, 90 and one-year
disability scores, quality of life, function) and system-relevant (length of stay,
admissions)
Health economic outcomes: costs, cost-effectiveness
Methods:
Design, setting and participants: Parallel-arm multicenter randomized controlled trial at
11 Canadian hospitals. People => 60 years old with frailty (Clinical Frailty Scale score
of 4/9) having major elective non-cardiac surgery (vascular, intrathoracic,
intraabdominal, pelvic, ENT) with expected length of stay of => 2 days will be included.
Intervention: Home-based exercise program with demonstrated efficacy, feasibility and
acceptability tailored for people with frailty.
Outcomes and sample size: Co-primary outcomes are patient-reported disability 30 days
after surgery (validated WHODAS tool) and prospectively collected in-hospital
complications (validated POMS tool). 750 participants (375/arm) will provide 98% power
for disability (control mean score 35 (SD 25; MID=8)) and 90% power for complications
(55% complication rate (25% relative risk reduction)) (α=0.025; 2 pair-wise comparisons).
Due to surgical delays and cancellations as a result of the COVID-19 pandemic, our trial
sample size has seen more participants having surgery outside of their expected time to
operation than originally predicted. To account for this, and to ensure adequate power
for our analyses, our final sample size will be increased to 850 participants.
Expertise: Our team features multidisciplinary clinical and methodological experts,
nationally representative knowledge users and patient representatives.
Expected outcomes: Older people with frailty are a growing and vulnerable segment of the
surgical population and are under-represented in existing studies. Exercise
prehabilitation is a high-priority research question which may be most relevant to people
with frailty given their physical and physiologic vulnerabilities. This study, featuring
patient-reported outcomes and an integrated knowledge translation approach will produce
generalizable findings directly relevant to patients, families, caregivers, and knowledge
users.
