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Home-Based Prehabilitation for Older Surgical Patients With Frailty: A Randomized Clinical Trial
Daniel I McIsaac1,2,3, Susan Lee4,5, Dean Fergusson6
1Department of Anesthesiology and Pain Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Importance:
Explanatory trials suggest that prehabilitation has efficacy in improving surgical outcomes. The effectiveness of offering home-based prehabilitation across multiple centers and for older adults with frailty remains unknown.
Objective:
To evaluate the effectiveness of offering coach-supported, home-based prehabilitation to older surgical patients with frailty.
Design, Setting, And Participants:
This study is a pragmatic, parallel-arm, multicenter randomized clinical trial with embedded qualitative assessment. Clinicians and assessors were fully blinded; participants were partially blinded in that the control arm received publicly available activity and nutritional guidelines. From March 2, 2020, to February 8, 2024, participants aged 60 years and older with frailty (Clinical Frailty Scale score ≥4) scheduled for elective, inpatient noncardiac surgery were recruited from surgeon's offices at 13 centers in Canada. Data analysis was completed from October 3, 2024, to December 5, 2024.
Intervention:
Assignment to a home-based, multimodal program of exercise and personalized nutritional recommendations, remotely supported by coaches using a theory-based approach to enhance adherence.
Main Outcomes And Measures:
The coprimary outcomes were patient-reported disability 30 days after surgery using the World Health Organization Disability Assessment Schedule 2.0 and the incidence of any postoperative complication during the surgical hospitalization. Barriers to adherence were identified using the Theoretical Domains Framework. Secondary outcomes were intervention-attributable safety events, health-related quality of life, survival, falls, complication severity, activities of daily living, length of stay, discharge disposition, lower limb function, and readmission. Analysis was by mixed-effects regression, adjusting for stratification and prespecified prognostic factors.
Results:
Of 992 eligible participants, 847 (85.4%) were randomized (423 to prehabilitation and 424 to usual care), and 705 participants had their planned surgery (353 in the prehabilitation group and 352 in the usual care group). A total of 452 participants (53.4%) were female, and mean (SD) participant age was 71.7 (7.1) years. A median (IQR) of 4 weeks (3-7) of prehabilitation enrollment was achieved. Preoperative safety outcomes did not differ between groups. Participants assigned to prehabilitation reported a mean (SD) postoperative disability score of 23.5 (21.8) compared to 24.7 (23.8) for usual care (adjusted mean difference, -1.4; 97.5% CI, -4.9 to 2.0; P = .36). Complications occurred in 177 participants (50.1%) assigned to prehabilitation and 168 control participants (47.7%) (adjusted odds ratio, 1.05; 97.5% CI, 0.73-1.49; P = .78). Participants completing more than 75% of prescribed exercises reported significantly lower disability scores with prehabilitation (mean difference, -4.9; 97.5% CI, -9.8 to -0.01; P = .02), but there was no significant difference in complications (odds ratio, 1.06; 97.5% CI, 0.67-1.67; P = .79). Primary barriers to adherence were competing priorities and motivation.
Conclusions And Relevance:
In this randomized clinical trial among older adults with frailty scheduled for surgery, assignment to home-based prehabilitation before surgery did not improve postoperative disability scores or reduce complications.
Trial Registration:
ClinicalTrials.gov Identifier: NCT04221295.
