High-technology TeleRehabilitation for the Treatment of the FRAgile Patient
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Salerno
About this trial
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.
Eligibility criteria
Qualifiers
Age 65 years or older.
Diagnosis of chronic heart failure for at least 6 months, on stable optimal medical therapy for at least 1 month, regardless of systolic function classification (HFrEF, HFmrEF, or HFpEF), and in NYHA class I-III.
Pre-frailty or frailty documented by validated instruments, defined by at least one of the following: Fried phenotype: pre-frailty (1-2 criteria) or frailty (3 or more criteria); Italian Frailty Index (IFI): score ≥1;
Ability to provide written informed consent, or availability of a legally authorized representative when applicable.
Disqualifiers
Age younger than 65 years.
NYHA class IV and/or high likelihood of heart transplantation or ventricular assist device (VAD) implantation within 6 months after screening.
Severe renal impairment (estimated glomerular filtration rate eGFR <30 mL/min/1.73 m²) or dialysis.
Inability to walk independently, even with assistive devices. SPPB total score <5/12, indicating severe functional impairment not compatible with safe execution of the study protocol, regardless of IFI or Fried criteria.
Trial design
Treatments tested in this trial
- Telerehabilitation
- Caregiver-Supervised Home Exercise Program
Treatment groups
70 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
University of Salerno
Lead sponsor
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Collaborator
Source ClinicalTrials.gov