High-technology telerehabilitation for the treatment of frail and pre-frail patients: the TeleRiab4FRA study design and protocol

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Introduction: Chronic heart failure (CHF) in older adults is frequently associated with frailty, reduced functional capacity, cognitive vulnerability, poor quality of life, and recurrent healthcare needs. Despite the recognized benefits of cardiac rehabilitation, access and adherence to conventional center-based programs remain suboptimal in frail and pre-frail patients. The TeleRiab4FRA study investigates whether an 8-week high-technology telerehabilitation program combining sensorimotor and cognitive training can improve functional capacity and multidimensional outcomes in frail and pre-frail older adults with CHF. Methods: TeleRiab4FRA is a randomized, controlled, prospective, monocentric, parallel-group, open-label, non-profit clinical trial enrolling approximately 80 patients aged ≥65 years with stable CHF, New York Heart Association functional class I-III, and documented frailty or pre-frailty. Participants are randomized in a 1:1 ratio to a telerehabilitation group or to a caregiver-supervised home-based rehabilitation group. The telerehabilitation intervention is delivered through a synchronous digital platform using CE-marked devices for remote monitoring of electrocardiographic tracing, heart rate, peripheral oxygen saturation, and blood pressure. Both groups receive an 8-week individualized program including motor and cognitive training tailored according to frailty status. Assessments are performed at baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks. The primary endpoint is the change in peak oxygen uptake (VO₂peak) measured by cardiopulmonary exercise testing from baseline to 8 weeks. Secondary outcomes include frailty status assessed by the Italian Frailty Index, physical performance, cognitive function, health-related quality of life, adherence, caregiver burden, perceived stress, technological usability, biomarkers, and safety events. Expected results: We hypothesize that high-technology telerehabilitation will lead to greater improvement in functional capacity than caregiver-supervised home-based rehabilitation. We further hypothesize favorable effects on frailty status, physical performance, cognitive outcomes, adherence, usability, and safety, with maintenance of any functional benefits at the 24-week follow-up. These statements represent prespecified hypotheses and not study findings. Conclusion: TeleRiab4FRA is designed to evaluate the clinical utility, feasibility, and safety of a synchronous, technology-enabled telerehabilitation model for frail and pre-frail older adults with CHF. If effective, this approach may support the development of scalable, personalized, and patient-centered rehabilitation pathways integrating clinical supervision, digital monitoring, and home-based care. Clinical trial registration: ClinicalTrials.gov, identifier NCT07561021.

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