Frail Elderly Syndrome, Heart Failure, Prefrail Elderly
Conditions
Keywords
Chronic Heart Failure, Cardiac Rehabilitation, Tele-rehabilitation, Telemedicine, Exercise Training, Remote Monitoring, mHealth, Wearable Sensors, Home-based Rehabilitation, Digital Health
Brief summary
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.
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.
Interventions
BEHAVIORALTelerehabilitation
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.
BEHAVIORALCaregiver-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.
Sponsors
University of Salerno
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Where applicable, endpoint assessment/extraction will be performed by personnel not involved in delivering the intervention, and the statistical analysis will be conducted on an anonymized dataset.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VO₂peak from baseline to 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mini-Mental State Examination (MMSE) Score | 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. |
| Change in Montreal Cognitive Assessment (MoCA) Score | 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. |
| Biochemical Parameters | Baseline, 8 weeks, and 24 weeks | Change in B-type Natriuretic Peptide (BNP) Levels (picograms per milliliter) |
| Change in Biochemical Parameters | Baseline, 8 weeks, and 24 weeks | Change in Atrial Natriuretic Peptide (ANP) Levels (picograms per milliliter) |
| Change in Zarit Burden Interview-12 (ZBI-12) Score | 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. |
| Change in Perceived Stress Scale-10 (PSS-10) Score | 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. |
| System Usability Scale (SUS) Score | 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. |
| Treatment Adherence | 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. |
| Change in Italian Frailty Index (IFI) | 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. |
| Change in Quality of Life Assessed by Short Form-36 (SF-36) | 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. |
| Change in Short Physical Performance Battery (SPPB) Score | 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. |
Contacts
CONTACTAlessia Bramanti, Electronic Engineering
Outcome results
None listed