Evaluating the Impact of Telehealth Exercise Prehabilitation on Cardiometabolic Health in Bariatric Surgery Candidates: Protocol for the BARI-Prehab Randomized Controlled Trial

评估远程医疗运动术前康复对减肥手术候选者心血管代谢健康的影响:BARI-Prehab随机对照试验方案

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Abstract

BACKGROUND: Obesity affects over one billion people globally and is a leading contributor to chronic disease. For those with clinically severe obesity, metabolic and bariatric surgery (MBS) is the most effective intervention for long-term weight loss. However, surgery is often delayed due to systemic barriers, during which time patients may experience further health decline. Low cardiorespiratory fitness is a known risk factor for perioperative complications, prompting recommendations for prehabilitation to target readiness for surgery. Despite this, few patients meet physical activity guidelines, and supervised preoperative exercise programs are rarely offered in routine care. Telehealth-delivered exercise programs offer a promising solution, but evidence of their feasibility, acceptability, and impact in the MBS setting remains limited. OBJECTIVE: This study (BARI-Prehab) aims to assess the efficacy and acceptability of a telehealth-delivered prehabilitation exercise program in improving cardiometabolic health among patients awaiting MBS. METHODS: In this multicenter, open-label, randomized controlled trial, we will randomize 48 adult participants (1:1) to either usual care (control group) or a 4-week telehealth exercise intervention. The primary outcome is aerobic capacity (VO(2) in mL/kg/min at the anaerobic threshold), measured using cardiopulmonary exercise testing. Secondary outcomes include resting heart rate, heart rate variability, resting metabolic rate, body composition, grip strength, and 7-day physical activity. Intervention acceptability will also be evaluated. RESULTS: Data collection and analysis are ongoing. This trial, funded in September 2020, will evaluate the capacity of a telehealth exercise program to improve cardiometabolic health and determine its suitability for implementation in the MBS preoperative pathway. Following initial protocol development, ethics approval, and trial setup, the clinical phase formally commenced with registration on June 16, 2023. Enrollment is ongoing, with a projected end date of March 2026. As of May 2025, a total of 220 patients have been screened for participation, of whom 30 have enrolled in the trial. The first results are expected to be submitted for publication by mid-2026. CONCLUSIONS: The BARI-Prehab trial will provide evidence on the acceptability and impact of a remotely delivered exercise intervention in the context of MBS. These findings will have implications for the design of accessible, scalable preoperative care models. The significance of this research lies in its potential to guide clinical practice, inform policy, and improve health outcomes for patients undergoing MBS. TRIAL REGISTRATION: ClinicalTrials.gov NCT05235945; https://clinicaltrials.gov/study/NCT05235945. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/77538.

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