Not_yet_recruitingNANCT07561021

High-technology TeleRehabilitation for the Treatment of the FRAgile Patient

Sponsor: University of Salerno

Trial Details

ConditionHeart Failure, Prefrail Elderly, Frail Elderly Syndrome
InterventionTelerehabilitation; Caregiver-Supervised Home Exercise Program
PhaseNA
StatusNot_yet_recruiting
Participants70
Est. Completion15 Jan 2027
Last Updated7 May 2026

Primary Outcome

Change in VO#max from baseline to 8 weeks

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: * 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; Short Physical Performance Battery (SPPB): total score 5-9/12, consistent with functional frailty; or total score 10/12, consistent with pre-frailty if the reduction is attributable to the sit-to-stand test, as documented in the case report form. * Ability to provide written informed consent, or availability of a legally authorized representative when applicable. * Availability of a caregiver, when required for participation in the rehabilitation program. Exclusion Criteria: * 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. * Absence of pre-frailty/frailty, defined as: Fried phenotype = 0 criteria, and IFI = 0, and SPPB ≥ 11/12 (or 10/12 without evidence of impairment in the sit-to-stand component according to the predefined criterion). * 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. * Other serious diseases substantially limiting life expectancy (for example, end-stage cancer or end-stage lung disease). * Severe visual impairment preventing completion of study procedures even with caregiver support and reasonable accommodations. * Current or suspected pregnancy.

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