Heart FailureTeleRiab4FraNCT07561021
High-technology TeleRehabilitation for the Treatment of the FRAgile Patient
A study testing Telerehabilitation and Caregiver-Supervised Home Exercise Program in people with Heart Failure and Prefrail Elderly, run by University of Salerno.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure, Prefrail Elderly, Frail Elderly Syndrome
- What is being tested?
- Telerehabilitation and Caregiver-Supervised Home Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2026to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Heart Failure, Prefrail Elderly, Frail Elderly Syndrome
- Being tested
- Telerehabilitation, Caregiver-Supervised Home Exercise Program
- Keywords
- Chronic Heart Failure, Cardiac Rehabilitation, Tele-rehabilitation, Telemedicine, Exercise Training, Remote Monitoring, mHealth, Wearable Sensors, Home-based Rehabilitation, Digital Health
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationBehavioural
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.
Caregiver-Supervised Home Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Caregiver-Supervised Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks
Biochemical Parameters
Change in B-type Natriuretic Peptide (BNP) Levels (picograms per milliliter)
Measured: Baseline, 8 weeks, and 24 weeks
Change in Biochemical Parameters
Change in Atrial Natriuretic Peptide (ANP) Levels (picograms per milliliter)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Treatment Adherence
Adherence will be assessed as the percentage of scheduled motor and cognitive training sessions completed during the intervention period.
Measured: Throughout the 8-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start15 May 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salerno
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
- Responsible party
- Principal investigator, Alessia Bramanti, University of Salerno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561021
- Sponsor's protocol ID
- TeleRiab4Fra
- Acronym
- TeleRiab4Fra
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40957013Keteyian 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.
PubMed 35135961Burns 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.
PubMed 10339280Denfeld 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.
PubMed 38099896McDonagh 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.
PubMed 40107957Lee 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.
PubMed 31950775Fried 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.
PubMed 11253156Jansen-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.
PubMed 26431260Bramanti A, Ciccarelli M, Carrizzo A, Bramanti P, Visco V, Calabrese M, Garofano M, Di Palo MP, Pessolano C, Romano S, Nocera S, Scanniello G, Vecchione C. High-technology telerehabilitation for the treatment of frail and pre-frail patients: the TeleRiab4FRA study design and protocol. Front Digit Health. 2026 Aug 24;8:1929955. doi: 10.3389/fdgth.2026.1929955. eCollection 2026.
PubMed 42707309
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-technology TeleRehabilitation for the Treatment of the FRAgile Patient
- ClinicalTrials.gov ID
- NCT07561021
- Acronym / sponsor ID
- TeleRiab4Fra / TeleRiab4Fra
- Conditions
- Heart Failure, Prefrail Elderly, Frail Elderly Syndrome
- Keywords
- Chronic Heart Failure, Cardiac Rehabilitation, Tele-rehabilitation, Telemedicine, Exercise Training, Remote Monitoring, mHealth, Wearable Sensors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of SalernoUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TELEREHABILITATION | Experimental | Behavioral: TelerehabilitationParticipants 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. |
| Caregiver-Supervised Home Exercise | Active comparator | Behavioral: Caregiver-Supervised Home Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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;
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationParticipants 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. | Behavioural | TELEREHABILITATION |
| Caregiver-Supervised Home Exercise ProgramParticipants 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. | Behavioural | Caregiver-Supervised Home Exercise |
Primary outcome
Change in VO₂peak from baseline to 8 weeks
Time frame: 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.
11 secondary outcomes
Change in Italian Frailty Index (IFI)
Time frame: Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks
Change in Short Physical Performance Battery (SPPB) Score
Time frame: Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks
Change in Quality of Life Assessed by Short Form-36 (SF-36)
Time frame: Baseline, 8 weeks, and 24 weeks
Change in Mini-Mental State Examination (MMSE) Score
Time frame: Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks
Change in Montreal Cognitive Assessment (MoCA) Score
Time frame: Baseline, 4 weeks, 8 weeks, 16 weeks, and 24 weeks
Biochemical Parameters
Time frame: Baseline, 8 weeks, and 24 weeks
Change in Biochemical Parameters
Time frame: Baseline, 8 weeks, and 24 weeks
Change in Zarit Burden Interview-12 (ZBI-12) Score
Time frame: Baseline and 8 weeks
Change in Perceived Stress Scale-10 (PSS-10) Score
Time frame: Baseline and 8 weeks
System Usability Scale (SUS) Score
Time frame: 8 weeks
Treatment Adherence
Time frame: Throughout the 8-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 40957013Cigarroa 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.
- Background: PubMed 35135961Keteyian 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.
- Background: PubMed 10339280Burns 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.
- Background: PubMed 38099896Denfeld 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.
- Background: PubMed 40107957McDonagh 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.
- Background: PubMed 31950775Lee 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.
- Background: PubMed 11253156Fried 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.
- Background: PubMed 26431260Jansen-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.
- Derived from this study: PubMed 42707309Bramanti A, Ciccarelli M, Carrizzo A, Bramanti P, Visco V, Calabrese M, Garofano M, Di Palo MP, Pessolano C, Romano S, Nocera S, Scanniello G, Vecchione C. High-technology telerehabilitation for the treatment of frail and pre-frail patients: the TeleRiab4FRA study design and protocol. Front Digit Health. 2026 Aug 24;8:1929955. doi: 10.3389/fdgth.2026.1929955. eCollection 2026.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation and Caregiver-Supervised Home Exercise Program in people with Heart Failure and Prefrail Elderly, run by University of Salerno.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessia Bramanti, Electronic Engineering (+393483809181, abramanti@unisa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VO₂peak from baseline to 8 weeks (time frame: Baseline (T=0) and end of intervention (T=2, 8 weeks), follow up (T=4, 24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07561021, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.