Heart FailureTELEREHAB-HFNCT07023536

Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure

An observational study of Heart Failure, run by University of Salerno at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

The goal of this observational study is to evaluate whether a home-based cardiac tele-rehabilitation program can improve functional capacity in adults (18 years and older) with chronic heart failure. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: TELEREHABILITATION-YES and TELEREHABILITATION-NO
Type of treatment: Lifestyle or therapy programme
How many people: 205 participants
Where: 1 siteItaly
Study dates: 10 Jun 2025to 1 Dec 2026
Phase: Observational
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: dults aged 18 years or older with a diagnosis of chronic heart failure, including heart failure with reduced ejection fraction (HFrEF), mildly reduced ejection fraction (HFmrEF), or preserved ejection fraction (HFpEF), and classified as NYHA functional class I to III, referred for cardiac rehabilitation at a tertiary care center. Participants must be clinically stable, receiving optimal medical therapy, and able to participate in either an in-person or home-based telerehabilitation program. Digital literacy, either of the patient or a caregiver, is required for inclusion in the telerehabilitation group. Both sexes are included. Patients with severe comorbidities that significantly limit life expectancy or with NYHA class IV heart failure are excluded.

Who may be able to join

Age ≥ 18 years
Diagnosis of chronic heart failure for at least 6 months, with stable optimal medical therapy for at least 1 month
New York Heart Association (NYHA) functional class I, II, or III
Hospitalization or outpatient visit requiring intravenous therapy (diuretics, vasodilators, or inotropes) within the past 12 months
Ability to provide informed consent or presence of a legal representative
Digital literacy of the patient and/or caregiver

Who cannot join

Age < 18 years
Pregnancy
NYHA class IV heart failure
Severe renal insufficiency (eGFR <30 ml/min/1.73 m²) or on dialysis
Other serious illnesses significantly limiting life expectancy (e.g., end-stage cancer, advanced pulmonary disease)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alessia Bramanti, Electronic Engineering contact

+393483809181

abramanti@unisa.it

Italy1 site, 1 recruiting

Hospital University San Giovanni di Dio e Ruggi d'Aragona
Salerno
Alessia Bramanti, Associate Professor
Recruiting

Other trials in Italy

About this study

Official title: Evaluation of the Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure

Does tele-rehabilitation improve peak oxygen uptake (VO₂ max) compared to standard in-hospital rehabilitation? Does it improve cardiac function, exercise tolerance, biochemical markers, and quality of life? Are functional gains maintained at 24 weeks? Researchers will compare patients who opt for tele-rehabilitation using wearable devices and a remote monitoring platform with those undergoing standard in-person rehabilitation. Participants will follow an 8-week individualized training program and undergo assessments at baseline, 4, 8, 16, and 24 weeks.

Read the detailed description

This prospective, single-center, non-pharmacological observational study aims to evaluate the effectiveness and feasibility of a structured, home-based cardiac telerehabilitation program in adults with chronic heart failure (CHF). The primary objective is to determine whether a telemedicine-based model can improve patients' functional capacity, as measured by maximal oxygen uptake (VO₂max), when compared to conventional in-hospital cardiac rehabilitation.

Participants will voluntarily enroll in either the telerehabilitation group or the standard rehabilitation group. Both groups follow the same 8-week aerobic exercise protocol, based on current international guidelines for heart failure management. The program includes warm-up, interval and endurance training, and cooldown, with exercise intensity personalized using cardiopulmonary exercise testing (CPET).

The telerehabilitation group will perform all sessions at home using a certified telehealth platform (Khymeia Virtual Reality Rehabilitation System - VRRS), which enables real-time supervision via secure videoconferencing. Participants are equipped with wearable medical-grade sensors for continuous monitoring of electrocardiogram (ECG), heart rate, blood pressure, and peripheral capillary oxygen saturation (SpO₂). The system offers automated data recording, performance feedback, and safety alerts, ensuring standardized care delivery and real-time clinical oversight. Before home-based training begins, participants receive structured in-person training to ensure safe and effective use of the digital tools.

Clinical and functional data are collected at baseline and follow-up visits at 4, 8, 16, and 24 weeks. The study also investigates patient adherence, safety, and the usability of digital rehabilitation tools. No investigational drugs or invasive procedures are involved. The findings will inform future implementation of scalable digital rehabilitation models in heart failure management and contribute to health system innovation in chronic disease care.

Conditions: Heart Failure
Being tested: TELEREHABILITATION-YES, TELEREHABILITATION-NO
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.

TELEREHABILITATION-YESBehavioural
This intervention consists of a structured 8-week cardiac rehabilitation program performed at the patient's home using a certified telemedicine platform. Sessions are delivered in synchronous mode with real-time supervision by a physiotherapist through secure video conferencing. Each session includes warm-up, endurance training, and cooldown exercises, with personalized intensity based on cardiopulmonary exercise testing. Patients are equipped with wearable medical devices for continuous monitoring of vital signs (ECG, heart rate, blood pressure, oxygen saturation) and motion sensors to assess exercise execution and adherence. All data are transmitted securely and stored automatically in the system's database. In addition to the exercise protocol, participants undergo baseline and follow-up assessments including blood biomarkers, echocardiography, cardiopulmonary exercise testing, and quality-of-life questionnaires.
TELEREHABILITATION-NOBehavioural
This intervention involves a traditional 8-week cardiac rehabilitation program carried out at a hospital-based outpatient facility. Patients attend sessions in person under the direct supervision of a physiotherapist. Each session includes warm-up, endurance training using a stationary bike, and cooldown. Vital signs (e.g., heart rate, blood pressure, oxygen saturation) are monitored manually by the physiotherapist, and exercise tolerance is assessed using standardized clinical scales (e.g., Borg and RPE). In addition to the exercise protocol, participants undergo baseline and follow-up assessments including blood biomarkers, echocardiography, cardiopulmonary exercise testing, and validated quality-of-life questionnaires. This group serves as the control for evaluating the effectiveness of the home-based telerehabilitation model.

Study groups in NCT07023536
Study group	Role	What they receive
TELEREHABILITATION-YES (Intervention Group)		Participants will receive a structured 8-week cardiac rehabilitation program conducted entirely at home through a certified telehealth platform (Khymeia VRRS system). The intervention includes real-time supervision by a physiotherapist via videoconferencing, and the use of wearable medical devices for continuous monitoring of vital signs (ECG, heart rate, SpO₂, blood pressure) and motion tracking. Each session includes warm-up, endurance training, and cooldown exercises, with intensity personalized based on baseline cardiopulmonary testing. The platform provides automated data recording, safety alerts, and performance feedback to ensure high-quality remote care. Patients are trained in-person before starting home-based sessions to ensure proper use of the system and adherence to the protocol. Receives: Behavioral: TELEREHABILITATION-YES
TELEREHABILITATION-NO (Control Group)		Participants in this group will undergo a standard 8-week cardiac rehabilitation program delivered in person at the outpatient facility under direct supervision of a physiotherapist. This group receives face-to-face rehabilitation consisting of individualized exercise sessions performed at the hospital's cardiac rehabilitation unit. Each session includes warm-up, endurance training on a stationary bike, and cooldown, following international guidelines for heart failure patients. Vital signs (heart rate, blood pressure, oxygen saturation) are manually measured and recorded by the physiotherapist, who also administers fatigue and dyspnea scales (Borg and Rate of Perceived Exertion - RPE) throughout the program. No wearable technology is used in this group; monitoring is performed through direct clinical observation and documentation in the medical record. Receives: Behavioral: TELEREHABILITATION-NO

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in VO₂max from baseline to 8 weeks
The primary outcome is the change in maximal oxygen consumption (VO₂max) from baseline to 8 weeks in patients with chronic heart failure undergoing a cardiac telerehabilitation program compared to a traditional in-person rehabilitation program. VO₂max is assessed via cardiopulmonary exercise testing (CPET). The intervention aims to achieve a clinically meaningful increase of approximately 20% in VO₂max. VO₂max is a key marker of functional capacity and cardiovascular health, and its improvement is associated with better prognosis, reduced hospitalizations, and enhanced quality of life.
Measured: Baseline (T=0) and end of intervention (T=2, 8 weeks)

Secondary outcomes (19)

VO₂max at 24-week follow-up
This outcome assesses VO₂max measured at 24 weeks following the end of the intervention period, in order to evaluate the evolution of functional capacity over time. VO₂max is assessed using cardiopulmonary exercise testing (CPET) at baseline, 8 weeks, and 24 weeks. The analysis will examine whether any changes observed after the intervention are sustained, reversed, or further modified at follow-up.
Measured: follow-up (T=4, 24 weeks)
Change in functional capacity assessed by 6-minute walk test (6MWT)
Functional capacity will be measured using the 6-minute walk test (6MWT), a validated submaximal exercise test in heart failure patients. The distance walked will be recorded at baseline, after the 8-week intervention, and at 24-week follow-up. Improvements in distance will reflect better exercise tolerance, which is a relevant indicator of clinical status and therapeutic efficacy.
Measured: Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Quality of Life
Quality of life (QoL) will be measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score, a validated instrument specifically designed to assess symptom burden, functional status, social limitations, and quality of life in patients with chronic heart failure (CHF). The score ranges from 0 to 100, where higher scores indicate better health status and quality of life.
Measured: Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Quality of Life
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 (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Biochemical Parameters
Biochemical Parameters: Change in B-type Natriuretic Peptide (BNP) Levels (picograms per milliliter)
Measured: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Biochemical Parameters
Biochemical Parameters: Change in N-terminal pro-BNP (NT-proBNP) Levels (picograms per milliliter)
Measured: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Biochemical Parameters
Biochemical Parameters: Change in Serum Creatinine (milligrams per deciliter)
Measured: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Biochemical Parameters
Biochemical Parameters: Change in Estimated Glomerular Filtration Rate (eGFR) (milliliters per minute per 1.73 square meters)
Measured: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Biochemical Parameters
Biochemical Parameters: Change in Serum Sodium Levels (millimoles per liter)
Measured: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Biochemical Parameters
Biochemical Parameters: Change in Serum Potassium Levels (millimoles per liter)
Measured: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Biochemical Parameters
Biochemical Parameters: Change in Serum Chloride Levels (millimoles per liter)
Measured: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Functional ECG-Derived Parameters
ECG-Derived Parameters: Change in Heart Rate Variability (HRV) (milliseconds)
Measured: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Functional ECG-Derived Parameters
ECG-Derived Parameters: Change in Respiratory Rate (breaths per minute)
Measured: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Functional Echocardiographic derived Parameters
Echocardiographic Parameters: Change in Left Ventricular Ejection Fraction (LVEF) (percent)
Measured: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Functional Echocardiographic derived Parameters
Echocardiographic Parameters: Change in Diastolic Function - E/A Ratio (unitless)
Measured: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Functional Echocardiographic derived Parameters
Echocardiographic Parameters: Change in Left Ventricular End-Diastolic Volume (milliliters)
Measured: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Functional Echocardiographic derived Parameters
Echocardiographic Parameters: Change in Left Ventricular End-Systolic Volume (milliliters)
Measured: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in cognitive function assessed by Mini-Mental State Examination (MMSE)
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 (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in physical performance assessed by Short Physical Performance Battery (SPPB)
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 (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 20251 Dec 2026

First posted17 Jun 2025
Study start10 Jun 2025
Primary completion1 Jul 2026 (estimated)
Study completion1 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 205 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07023536
Sponsor's protocol ID: UNISA-TELEREHABHF-2025
Acronym: TELEREHAB-HF
Status last verified: Mar 2026
First submitted: 8 Jun 2025
Last updated: 11 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
PubMed 35363499
Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.
PubMed 34458905
Sui X, Gutekunst WR. Cascade Alternating Metathesis Cyclopolymerization of Diynes and Dihydrofuran. ACS Macro Lett. 2022 May 17;11(5):630-635. doi: 10.1021/acsmacrolett.2c00140. Epub 2022 Apr 18.
PubMed 35570817
Sullivan DJ Jr. A Single Human Cerebral Malaria Histopathologic Study Can Be Worth a Thousand Experiments. mBio. 2015 Nov 17;6(6):e01818-15. doi: 10.1128/mBio.01818-15.
PubMed 26578683
Taylor RS, Dalal HM, Zwisler AD. Cardiac rehabilitation for heart failure: 'Cinderella' or evidence-based pillar of care? Eur Heart J. 2023 May 1;44(17):1511-1518. doi: 10.1093/eurheartj/ehad118.
PubMed 36905176
Flynn KE, Pina IL, Whellan DJ, Lin L, Blumenthal JA, Ellis SJ, Fine LJ, Howlett JG, Keteyian SJ, Kitzman DW, Kraus WE, Miller NH, Schulman KA, Spertus JA, O'Connor CM, Weinfurt KP; HF-ACTION Investigators. Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1451-9. doi: 10.1001/jama.2009.457.
PubMed 19351942
Taylor RS, Walker S, Smart NA, Piepoli MF, Warren FC, Ciani O, Whellan D, O'Connor C, Keteyian SJ, Coats A, Davos CH, Dalal HM, Dracup K, Evangelista LS, Jolly K, Myers J, Nilsson BB, Passino C, Witham MD, Yeh GY; ExTraMATCH II Collaboration. Impact of Exercise Rehabilitation on Exercise Capacity and Quality-of-Life in Heart Failure: Individual Participant Meta-Analysis. J Am Coll Cardiol. 2019 Apr 2;73(12):1430-1443. doi: 10.1016/j.jacc.2018.12.072.
PubMed 30922474
Taylor RS, Long L, Mordi IR, Madsen MT, Davies EJ, Dalal H, Rees K, Singh SJ, Gluud C, Zwisler AD. Exercise-Based Rehabilitation for Heart Failure: Cochrane Systematic Review, Meta-Analysis, and Trial Sequential Analysis. JACC Heart Fail. 2019 Aug;7(8):691-705. doi: 10.1016/j.jchf.2019.04.023. Epub 2019 Jul 10.
PubMed 31302050
McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
PubMed 34447992
Isernia S, Pagliari C, Morici N, Toccafondi A, Banfi PI, Rossetto F, Borgnis F, Tavanelli M, Brambilla L, Baglio F; CPTM Group. Telerehabilitation Approaches for People with Chronic Heart Failure: A Systematic Review and Meta-Analysis. J Clin Med. 2022 Dec 21;12(1):64. doi: 10.3390/jcm12010064.
PubMed 36614865
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.
PubMed 10339280
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.
PubMed 26431260
Garofano M, Vecchione C, Calabrese M, Rusciano MR, Visco V, Granata G, Carrizzo A, Galasso G, Bramanti P, Corallo F, Pepe L, Budaci L, Ciccarelli M, Bramanti A. Evaluation of the Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure: Design and Rationale of the TELEREHAB-HF Study. Healthcare (Basel). 2025 Aug 21;13(16):2074. doi: 10.3390/healthcare13162074.
PubMed 40868691

Interested in taking part?

Alessia Bramanti, Electronic Engineering

+393483809181

abramanti@unisa.it

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure
ClinicalTrials.gov ID: NCT07023536
Acronym / sponsor ID: TELEREHAB-HF / UNISA-TELEREHABHF-2025
Conditions: Heart Failure
Keywords: Chronic Heart Failure, Cardiac Rehabilitation, Tele-rehabilitation, Telemedicine, Exercise Training, Remote Monitoring, mHealth, Wearable Sensors
Study type: Observational
Recruitment status: Recruiting
Enrolment: 205 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: 10 Jun 2025 (actual)
Primary completion: 1 Jul 2026 (estimated)
Study completion: 1 Dec 2026 (estimated)
First posted: 17 Jun 2025 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
TELEREHABILITATION-YES (Intervention Group)	–	Behavioral: TELEREHABILITATION-YESParticipants will receive a structured 8-week cardiac rehabilitation program conducted entirely at home through a certified telehealth platform (Khymeia VRRS system). The intervention includes real-time supervision by a physiotherapist via videoconferencing, and the use of wearable medical devices for continuous monitoring of vital signs (ECG, heart rate, SpO₂, blood pressure) and motion tracking. Each session includes warm-up, endurance training, and cooldown exercises, with intensity personalized based on baseline cardiopulmonary testing. The platform provides automated data recording, safety alerts, and performance feedback to ensure high-quality remote care. Patients are trained in-person before starting home-based sessions to ensure proper use of the system and adherence to the protocol.
TELEREHABILITATION-NO (Control Group)	–	Behavioral: TELEREHABILITATION-NOParticipants in this group will undergo a standard 8-week cardiac rehabilitation program delivered in person at the outpatient facility under direct supervision of a physiotherapist. This group receives face-to-face rehabilitation consisting of individualized exercise sessions performed at the hospital's cardiac rehabilitation unit. Each session includes warm-up, endurance training on a stationary bike, and cooldown, following international guidelines for heart failure patients. Vital signs (heart rate, blood pressure, oxygen saturation) are manually measured and recorded by the physiotherapist, who also administers fatigue and dyspnea scales (Borg and Rate of Perceived Exertion - RPE) throughout the program. No wearable technology is used in this group; monitoring is performed through direct clinical observation and documentation in the medical record.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: dults aged 18 years or older with a diagnosis of chronic heart failure, including heart failure with reduced ejection fraction (HFrEF), mildly reduced ejection fraction (HFmrEF), or preserved ejection fraction (HFpEF), and classified as NYHA functional class I to III, referred for cardiac rehabilitation at a tertiary care center. Participants must be clinically stable, receiving optimal medical therapy, and able to participate in either an in-person or home-based telerehabilitation program. Digital literacy, either of the patient or a caregiver, is required for inclusion in the telerehabilitation group. Both sexes are included. Patients with severe comorbidities that significantly limit life expectancy or with NYHA class IV heart failure are excluded.

Key inclusion criteria (6 listed)

Age ≥ 18 years
Diagnosis of chronic heart failure for at least 6 months, with stable optimal medical therapy for at least 1 month
New York Heart Association (NYHA) functional class I, II, or III
Hospitalization or outpatient visit requiring intravenous therapy (diuretics, vasodilators, or inotropes) within the past 12 months
Ability to provide informed consent or presence of a legal representative

Key exclusion criteria (5 listed)

Age < 18 years
Pregnancy
NYHA class IV heart failure
Severe renal insufficiency (eGFR <30 ml/min/1.73 m²) or on dialysis
Other serious illnesses significantly limiting life expectancy (e.g., end-stage cancer, advanced pulmonary disease)

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
TELEREHABILITATION-YESThis intervention consists of a structured 8-week cardiac rehabilitation program performed at the patient's home using a certified telemedicine platform. Sessions are delivered in synchronous mode with real-time supervision by a physiotherapist through secure video conferencing. Each session includes warm-up, endurance training, and cooldown exercises, with personalized intensity based on cardiopulmonary exercise testing. Patients are equipped with wearable medical devices for continuous monitoring of vital signs (ECG, heart rate, blood pressure, oxygen saturation) and motion sensors to assess exercise execution and adherence. All data are transmitted securely and stored automatically in the system's database. In addition to the exercise protocol, participants undergo baseline and follow-up assessments including blood biomarkers, echocardiography, cardiopulmonary exercise testing, and quality-of-life questionnaires.	Behavioural	TELEREHABILITATION-YES (Intervention Group)
TELEREHABILITATION-NOThis intervention involves a traditional 8-week cardiac rehabilitation program carried out at a hospital-based outpatient facility. Patients attend sessions in person under the direct supervision of a physiotherapist. Each session includes warm-up, endurance training using a stationary bike, and cooldown. Vital signs (e.g., heart rate, blood pressure, oxygen saturation) are monitored manually by the physiotherapist, and exercise tolerance is assessed using standardized clinical scales (e.g., Borg and RPE). In addition to the exercise protocol, participants undergo baseline and follow-up assessments including blood biomarkers, echocardiography, cardiopulmonary exercise testing, and validated quality-of-life questionnaires. This group serves as the control for evaluating the effectiveness of the home-based telerehabilitation model.	Behavioural	TELEREHABILITATION-NO (Control Group)

Primary outcome

Change in VO₂max from baseline to 8 weeks
Time frame: Baseline (T=0) and end of intervention (T=2, 8 weeks)
The primary outcome is the change in maximal oxygen consumption (VO₂max) from baseline to 8 weeks in patients with chronic heart failure undergoing a cardiac telerehabilitation program compared to a traditional in-person rehabilitation program. VO₂max is assessed via cardiopulmonary exercise testing (CPET). The intervention aims to achieve a clinically meaningful increase of approximately 20% in VO₂max. VO₂max is a key marker of functional capacity and cardiovascular health, and its improvement is associated with better prognosis, reduced hospitalizations, and enhanced quality of life.

19 secondary outcomes

VO₂max at 24-week follow-up
Time frame: follow-up (T=4, 24 weeks)
Change in functional capacity assessed by 6-minute walk test (6MWT)
Time frame: Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Quality of Life
Time frame: Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Quality of Life
Time frame: Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Biochemical Parameters
Time frame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Biochemical Parameters
Time frame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Biochemical Parameters
Time frame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Biochemical Parameters
Time frame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Biochemical Parameters
Time frame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Biochemical Parameters
Time frame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Biochemical Parameters
Time frame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Functional ECG-Derived Parameters
Time frame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Functional ECG-Derived Parameters
Time frame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Functional Echocardiographic derived Parameters
Time frame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Functional Echocardiographic derived Parameters
Time frame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Functional Echocardiographic derived Parameters
Time frame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in Functional Echocardiographic derived Parameters
Time frame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in cognitive function assessed by Mini-Mental State Examination (MMSE)
Time frame: Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Change in physical performance assessed by Short Physical Performance Battery (SPPB)
Time frame: Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)

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 11 Mar 2026.
Results publication: PubMed 35363499Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
Results publication: PubMed 34458905Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.
Results publication: PubMed 35570817Sui X, Gutekunst WR. Cascade Alternating Metathesis Cyclopolymerization of Diynes and Dihydrofuran. ACS Macro Lett. 2022 May 17;11(5):630-635. doi: 10.1021/acsmacrolett.2c00140. Epub 2022 Apr 18.
Results publication: PubMed 26578683Sullivan DJ Jr. A Single Human Cerebral Malaria Histopathologic Study Can Be Worth a Thousand Experiments. mBio. 2015 Nov 17;6(6):e01818-15. doi: 10.1128/mBio.01818-15.
Results publication: PubMed 36905176Taylor RS, Dalal HM, Zwisler AD. Cardiac rehabilitation for heart failure: 'Cinderella' or evidence-based pillar of care? Eur Heart J. 2023 May 1;44(17):1511-1518. doi: 10.1093/eurheartj/ehad118.
Results publication: PubMed 19351942Flynn KE, Pina IL, Whellan DJ, Lin L, Blumenthal JA, Ellis SJ, Fine LJ, Howlett JG, Keteyian SJ, Kitzman DW, Kraus WE, Miller NH, Schulman KA, Spertus JA, O'Connor CM, Weinfurt KP; HF-ACTION Investigators. Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1451-9. doi: 10.1001/jama.2009.457.
Results publication: PubMed 30922474Taylor RS, Walker S, Smart NA, Piepoli MF, Warren FC, Ciani O, Whellan D, O'Connor C, Keteyian SJ, Coats A, Davos CH, Dalal HM, Dracup K, Evangelista LS, Jolly K, Myers J, Nilsson BB, Passino C, Witham MD, Yeh GY; ExTraMATCH II Collaboration. Impact of Exercise Rehabilitation on Exercise Capacity and Quality-of-Life in Heart Failure: Individual Participant Meta-Analysis. J Am Coll Cardiol. 2019 Apr 2;73(12):1430-1443. doi: 10.1016/j.jacc.2018.12.072.
Results publication: PubMed 31302050Taylor RS, Long L, Mordi IR, Madsen MT, Davies EJ, Dalal H, Rees K, Singh SJ, Gluud C, Zwisler AD. Exercise-Based Rehabilitation for Heart Failure: Cochrane Systematic Review, Meta-Analysis, and Trial Sequential Analysis. JACC Heart Fail. 2019 Aug;7(8):691-705. doi: 10.1016/j.jchf.2019.04.023. Epub 2019 Jul 10.
Results publication: PubMed 34447992McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
Results publication: PubMed 36614865Isernia S, Pagliari C, Morici N, Toccafondi A, Banfi PI, Rossetto F, Borgnis F, Tavanelli M, Brambilla L, Baglio F; CPTM Group. Telerehabilitation Approaches for People with Chronic Heart Failure: A Systematic Review and Meta-Analysis. J Clin Med. 2022 Dec 21;12(1):64. doi: 10.3390/jcm12010064.
Results publication: 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.
Results publication: 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.
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.

Alessia Bramanti, Electronic Engineering contact

+393483809181

abramanti@unisa.it

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by University of Salerno at 1 site in Italy.

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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

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 VO₂max from baseline to 8 weeks (time frame: Baseline (T=0) and end of intervention (T=2, 8 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 NCT07023536, which also lists 13 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 11 Mar 2026.