High-technology TeleRehabilitation for the Treatment of the FRAgile Patient

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

• Change in VO₂peak from baseline to 8 weeks [Срок оценки: Baseline (T=0) and end of intervention (T=2, 8 weeks), follow up (T=4, 24 weeks)]

Вторичные конечные точки (11)

• Change in Italian Frailty Index (IFI) [Срок оценки: Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks]
• Change in Short Physical Performance Battery (SPPB) Score [Срок оценки: Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks]
• Change in Quality of Life Assessed by Short Form-36 (SF-36) [Срок оценки: Baseline, 8 weeks, and 24 weeks]
• Change in Mini-Mental State Examination (MMSE) Score [Срок оценки: Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks]
• Change in Montreal Cognitive Assessment (MoCA) Score [Срок оценки: Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks]
• Biochemical Parameters [Срок оценки: Baseline, 8 weeks, and 24 weeks]
• Change in Biochemical Parameters [Срок оценки: Baseline, 8 weeks, and 24 weeks]
• Change in Zarit Burden Interview-12 (ZBI-12) Score [Срок оценки: Baseline and 8 weeks]
• Change in Perceived Stress Scale-10 (PSS-10) Score [Срок оценки: Baseline and 8 weeks]
• System Usability Scale (SUS) Score [Срок оценки: 8 weeks]
• Treatment Adherence [Срок оценки: Throughout the 8-week intervention period]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 40957013
• 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. PMID 35135961
• 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. PMID 10339280
• 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 PMID 38099896
• 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 Nationa PMID 40107957
• 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. PMID 31950775
• 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. PMID 11253156
• 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. PMID 26431260

Идентификаторы

NCT: NCT07561021 · TeleRiab4Fra

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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