High-technology TeleRehabilitation for the Treatment of the FRAgile Patient

Summary

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.

Conditions

• Heart Failure
• Prefrail Elderly
• Frail Elderly Syndrome

Interventions

BEHAVIORAL

Telerehabilitation

Participants will receive an 8-week individualized sensorimotor and cognitive telerehabilitation program delivered through a synchronous digital platform. The intervention includes motor training and cognitive training tailored to frailty level, with real-time remote supervision by healthcare professionals and continuous monitoring of vital signs, including ECG, heart rate, oxygen saturation, and blood pressure. Participants and caregivers will receive initial training and technical support for use of the telerehabilitation system.

BEHAVIORAL

Caregiver-Supervised Home Exercise Program

Participants will receive an 8-week individualized home-based sensorimotor and cognitive exercise program matched to frailty level. The program will be explained in person and then performed at home under caregiver or family supervision. It includes motor and cognitive exercises corresponding to those used in the intervention group, along with activity diary completion and monitoring of heart rate, oxygen saturation, and blood pressure according to study procedures.

Sponsors & Collaborators

• Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

  collaborator OTHER

• University of Salerno

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-15

Primary Completion

2027-01-15

Completion

2027-03-15