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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Telerehabilitation
BehavioralParticipants 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.
Caregiver-Supervised Home Exercise Program
BehavioralParticipants 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: TELEREHABILITATIONExperimental treatment 1 intervention
Group B: Caregiver-Supervised Home ExerciseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in VO₂peak from baseline to 8 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.
Time frame
Baseline (T=0) and end of intervention (T=2, 8 weeks), follow up (T=4, 24 weeks)Secondary outcomes
1
Change in Italian Frailty Index (IFI)
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.
Time frame
Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks2
Change in Short Physical Performance Battery (SPPB) Score
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.
Time frame
Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks3
Change in Quality of Life Assessed by Short Form-36 (SF-36)
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.
Time frame
Baseline, 8 weeks, and 24 weeks4
Change in Mini-Mental State Examination (MMSE) Score
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.
Time frame
Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Salerno
Lead sponsor
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: