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| Name | Class |
|---|---|
| Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona | OTHER |
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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 (VOâ‚‚peak) 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TELEREHABILITATION | Experimental | 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. |
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| Caregiver-Supervised Home Exercise | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telerehabilitation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in VOâ‚‚peak from baseline to 8 weeks | Functional capacity will be assessed as the change in peak oxygen uptake (VOâ‚‚peak, mL/kg/min) measured by cardiopulmonary exercise testing (CPET). The primary efficacy analysis will compare VOâ‚‚peak 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks |
| Change in Short Physical Performance Battery (SPPB) Score |
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Inclusion Criteria:
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.
Exclusion Criteria:
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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessia Bramanti, Electronic Engineering | Contact | +393483809181 | abramanti@unisa.it |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40957013 | Background | Cigarroa I, Reyes-Molina D, Vargas-Rios F, Lopez-Alarcon G, Jara-Aceituno S, Riquelme-Hernandez C, Zapata-Lamana R, Parra-Rizo MA. Effectiveness of Synchronous Telerehabilitation Versus Face-to-Face Physical Therapy in Older Adults Who Are Frail: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 16;14:e72318. doi: 10.2196/72318. | |
| 35135961 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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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.
|
| Caregiver-Supervised Home Exercise Program | Behavioral | 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. |
|
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) | 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 | 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 | 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 | Change in B-type Natriuretic Peptide (BNP) Levels (picograms per milliliter) | Baseline, 8 weeks, and 24 weeks |
| Change in Biochemical Parameters | 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 | 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 | 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 | 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 | 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 |
| Keteyian SJ, Jackson SL, Chang A, Brawner CA, Wall HK, Forman DE, Sukul D, Ritchey MD, Sperling LS. Tracking Cardiac Rehabilitation Utilization in Medicare Beneficiaries: 2017 UPDATE. J Cardiopulm Rehabil Prev. 2022 Jul 1;42(4):235-245. doi: 10.1097/HCR.0000000000000675. Epub 2022 Feb 8. |
| 10339280 | Background | Burns RB, Crislip D, Daviou P, Temkin A, Vesmarovich S, Anshutz J, Furbish C, Jones ML. Using telerehabilitation to support assistive technology. Assist Technol. 1998;10(2):126-33. doi: 10.1080/10400435.1998.10131970. |
| 38099896 | Background | Denfeld QE, Jha SR, Fung E, Jaarsma T, Maurer MS, Reeves GR, Afilalo J, Beerli N, Bellumkonda L, De Geest S, Gorodeski EZ, Joyce E, Kobashigawa J, Mauthner O, McDonagh J, Uchmanowicz I, Dickson VV, Lindenfeld J, Macdonald P. Assessing and managing frailty in advanced heart failure: An International Society for Heart and Lung Transplantation consensus statement. J Heart Lung Transplant. 2023 Nov 29:S1053-2498(23)02028-4. doi: 10.1016/j.healun.2023.09.013. Online ahead of print. |
| 40107957 | Background | McDonagh J, Ferguson C, Hilmer SN, Hubbard RE, Lindley RI, Driscoll A, Maiorana A, Wu L, Atherton JJ, Bajorek BV, Carr B, Delbaere K, Dent E, Duong MH, Hickman LD, Hopper I, Huynh Q, Jha SR, Keech A, Sim M, Singh GK, Villani A, Shang C, Hsu M, Vandenberg J, Davidson PM, Macdonald PS. An Expert Opinion on the Management of Frailty in Heart Failure from the Australian Cardiovascular Alliance National Taskforce. Heart Lung Circ. 2025 Jul;34(7):693-703. doi: 10.1016/j.hlc.2025.01.012. Epub 2025 Mar 19. |
| 31950775 | Background | Lee H, Lee E, Jang IY. Frailty and Comprehensive Geriatric Assessment. J Korean Med Sci. 2020 Jan 20;35(3):e16. doi: 10.3346/jkms.2020.35.e16. |
| 11253156 | Background | Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146. |
| 26431260 | Background | Jansen-Kosterink S, In 't Veld RH, Hermens H, Vollenbroek-Hutten M. A Telemedicine Service as Partial Replacement of Face-to-Face Physical Rehabilitation: The Relevance of Use. Telemed J E Health. 2015 Oct;21(10):808-13. doi: 10.1089/tmj.2014.0173. Epub 2015 Jun 4. |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |