High-technology TeleRehabilitation for the Treatment of the FRAgile Patient

NCT07561021 | Not Yet Recruiting

• 1 other identifier: TeleRiab4Fra
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure; Prefrail Elderly; Frail Elderly Syndrome

Keywords

Chronic Heart Failure; Cardiac Rehabilitation; Tele-rehabilitation; Telemedicine; Exercise Training; Remote Monitoring; mHealth; Wearable Sensors; Home-based Rehabilitation; Digital Health

Outcome Measures

Primary Outcomes (1)

• Change in VO#max 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.

  Baseline (T=0) and end of intervention (T=2, 8 weeks), follow up (T=4, 24 weeks)

Secondary Outcomes (11)

• Change in Italian Frailty Index (IFI)

  Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks

• Change in Short Physical Performance Battery (SPPB) Score

  Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks

• Change in Quality of Life Assessed by Short Form-36 (SF-36)

  Baseline, 8 weeks, and 24 weeks

• Change in Mini-Mental State Examination (MMSE) Score

  Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks

• Change in Montreal Cognitive Assessment (MoCA) Score

  Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks

Study Arms (2)

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.

Behavioral: Telerehabilitation

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.

Behavioral: Caregiver-Supervised Home Exercise Program

Interventions

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.

TELEREHABILITATION

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.

Caregiver-Supervised Home Exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salerno: lead
• Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona: collaborator

Related Publications (8)

• 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 BACKGROUND

• 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 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.

  PMID: 10339280 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.

  PMID: 38099896 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.

  PMID: 40107957 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.

  PMID: 31950775 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.

  PMID: 11253156 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.

  PMID: 26431260 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Central Study Contacts

Alessia Bramanti, Electronic Engineering

CONTACT

+393483809181; abramanti@unisa.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share