High-technology TeleRehabilitation for the Treatment of the FRAgile Patient (TeleRiab4Fra)

May 1, 2026 updated by: Alessia Bramanti, University of Salerno
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Frailty is a multidimensional condition associated with reduced physiological reserve, vulnerability to stressors, loss of functional capacity, and increased risk of hospitalization and dependency. In patients with chronic heart failure, frailty is highly prevalent and is associated with worse prognosis, lower exercise tolerance, poorer quality of life, and increased caregiver burden. Telerehabilitation may represent a scalable strategy to extend rehabilitation beyond hospital-based settings, improve continuity of care, and support safe home-based management in older adults with limited access to conventional services.

Frailty is a multidimensional condition associated with reduced physiological reserve, vulnerability to stressors, loss of functional capacity, and increased risk of hospitalization and dependency. In patients with chronic heart failure, frailty is highly prevalent and is associated with worse prognosis, lower exercise tolerance, poorer quality of life, and increased caregiver burden. Telerehabilitation may represent a scalable strategy to extend rehabilitation beyond hospital-based settings, improve continuity of care, and support safe home-based management in older adults with limited access to conventional services. This study is designed to evaluate whether a structured sensorimotor and cognitive telerehabilitation program provides greater benefit than a caregiver-supervised home exercise program in older adults with stable chronic heart failure and pre-frailty or frailty. The intervention is delivered over 8 weeks through a synchronous digital platform with remote clinical supervision and physiologic monitoring, while the control group performs an individualized home-based program with caregiver support. The study focuses on functional capacity as the main efficacy domain, with additional evaluation of frailty status, quality of life, cognitive performance, treatment adherence, caregiver burden, and selected biomarkers associated with heart failure and frailty. Follow-up assessments are included to explore whether any treatment effects are maintained over time.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alessia Bramanti, Electronic Engineering
  • Phone Number: +393483809181
  • Email: abramanti@unisa.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TELEREHABILITATION
Participants assigned to this arm 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 the participant's frailty level, with continuous remote monitoring of vital signs, including ECG, heart rate, oxygen saturation, and blood pressure. Participants and caregivers will receive initial training and technical support.
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.
Active Comparator: Caregiver-Supervised Home Exercise
Participants assigned to this arm will receive an 8-week individualized home-based sensorimotor and cognitive exercise program matched to the participant's frailty profile. The program will be explained in person and then continued at home under caregiver or family supervision. Participants will perform the same general categories of motor and cognitive exercises as the intervention group and will record activities in a daily diary, with monitoring of heart rate, oxygen saturation, and blood pressure according to study procedures.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in VO₂peak from baseline to 8 weeks
Time Frame: Baseline (T=0) and end of intervention (T=2, 8 weeks), follow up (T=4, 24 weeks)
Functional capacity will be assessed as the change in peak oxygen uptake (VO₂peak, mL/kg/min) measured by cardiopulmonary exercise testing (CPET). The primary efficacy analysis will compare VO₂peak at 8 weeks between the telerehabilitation group and the control group, adjusted for baseline values.
Baseline (T=0) and end of intervention (T=2, 8 weeks), follow up (T=4, 24 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Italian Frailty Index (IFI)
Time Frame: Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks
Frailty status will be assessed using the Italian Frailty Index (IFI). Changes over time will be evaluated and compared between the telerehabilitation group and the control group.
Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks
Change in Short Physical Performance Battery (SPPB) Score
Time Frame: Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks
Change in physical performance will be assessed using the Short Physical Performance Battery (SPPB), which includes tests of balance, gait speed, and chair stands. The SPPB provides a composite score ranging from 0 to 12, with higher scores indicating better lower extremity function and physical performance.
Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks
Change in Quality of Life Assessed by Short Form-36 (SF-36)
Time Frame: Baseline, 8 weeks, and 24 weeks
The Short Form Health Survey - 36 items (SF-36) evaluates general health status across multiple domains, including physical functioning, role limitations, pain, general health, vitality, social functioning, emotional well-being, and mental health. The total score ranges from 0 to 100, with higher scores indicating better health status and quality of life.
Baseline, 8 weeks, and 24 weeks
Change in Mini-Mental State Examination (MMSE) Score
Time Frame: Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE), a widely used screening tool for cognitive impairment. The MMSE evaluates orientation, attention, memory, language, and visuospatial skills. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. Scores will be collected to monitor changes in cognitive status over time in patients participating in the cardiac rehabilitation program.
Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks
Change in Montreal Cognitive Assessment (MoCA) Score
Time Frame: Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks
Cognitive performance will be assessed using the Montreal Cognitive Assessment (MoCA). Changes over time will be evaluated and compared between study groups.
Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks
Biochemical Parameters
Time Frame: Baseline, 8 weeks, and 24 weeks
Change in B-type Natriuretic Peptide (BNP) Levels (picograms per milliliter)
Baseline, 8 weeks, and 24 weeks
Change in Biochemical Parameters
Time Frame: Baseline, 8 weeks, and 24 weeks
Change in Atrial Natriuretic Peptide (ANP) Levels (picograms per milliliter)
Baseline, 8 weeks, and 24 weeks
Change in Zarit Burden Interview-12 (ZBI-12) Score
Time Frame: Baseline and 8 weeks
Caregiver burden will be assessed using the 12-item Zarit Burden Interview (ZBI-12). Changes over time will be evaluated to explore the impact of the intervention on caregiver burden.
Baseline and 8 weeks
Change in Perceived Stress Scale-10 (PSS-10) Score
Time Frame: Baseline and 8 weeks
Caregiver stress will be assessed using the 10-item Perceived Stress Scale (PSS-10). Changes over time will be evaluated to explore the impact of the intervention on caregiver stress.
Baseline and 8 weeks
System Usability Scale (SUS) Score
Time Frame: 8 weeks
Usability and acceptability of the telerehabilitation technology will be assessed in the telerehabilitation group using the System Usability Scale (SUS), a 10-item questionnaire with total scores ranging from 0 to 100, where higher scores indicate better usability.
8 weeks
Treatment Adherence
Time Frame: Throughout the 8-week intervention period
Adherence will be assessed as the percentage of scheduled motor and cognitive training sessions completed during the intervention period.
Throughout the 8-week intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Salerno

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

March 15, 2027

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TeleRiab4Fra

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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