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NCT07561021Not yet recruiting

High-technology TeleRehabilitation for the Treatment of the FRAgile Patient

Source: ClinicalTrials.gov · Last updated 7 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
70 (estimated)
First submitted
24 Apr 2026
Start date
15 May 2026
Primary completion date
15 Jan 2027
Lead sponsor
University of Salerno
NCT number
NCT07561021

What you commit to

  • Study type: Interventional
  • Planned participants: 70
  • From 15 May 2026 to the primary completion date, 15 Jan 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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).
  • 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.

Lab values

  • Severe renal impairment (estimated glomerular filtration rate eGFR \<30 mL/min/1.73 m²) or dialysis.

Age

  • Age younger than 65 years.

Other

  • Current or suspected pregnancy.

Who the study is looking for

  • 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.

Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.