High-technology TeleRehabilitation for the Treatment of the FRAgile Patient

The aim of this randomized controlled clinical trial is to evaluate the efficacy of an 8-week sensorimotor and cognitive telerehabilitation program in frail and pre-frail older adults with stable chronic heart failure. The study will compare a synchronous telerehabilitation intervention with a caregiver-supervised home exercise program. The primary question is whether telerehabilitation improves functional capacity, measured by change in peak oxygen uptake (VO₂peak) on cardiopulmonary exercise testing, more than the control intervention. A key secondary question is whether telerehabilitation improves frailty status, measured by the Italian Frailty Index (IFI), compared with the control group. Secondary outcomes include quality of life, physical performance, cognitive function, treatment adherence, caregiver burden and stress, and selected biomarkers related to heart failure and frailty. Participants will undergo baseline and follow-up clinical, functional, cognitive, and laboratory assessments and will be followed for up to 24 weeks.

NCT Number	NCT07561021
Lead Sponsor	University of Salerno Collaborators: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Conditions	Heart Failure, Prefrail Elderly, Frail Elderly Syndrome
Enrollment	70 participants
Start Date	2026-05-15
Primary Completion	2027-01-15 (estimated)
Study Completion	2027-03-15 (estimated)
Updated on ClinicalTrials.gov	2026-05-07