Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure

NCT07023536 | Recruiting

• 1 other identifier: UNISA-TELEREHABHF-2025
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

Brief 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. The main questions it aims to answer are: 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.

Conditions

Heart Failure

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 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.

  Baseline (T=0) and end of intervention (T=2, 8 weeks)

Secondary Outcomes (19)

• VO₂max at 24-week follow-up

  follow-up (T=4, 24 weeks)

• Change in functional capacity assessed by 6-minute walk test (6MWT)

  Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)

• Change in Quality of Life

  Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)

• Change in Quality of Life

  Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)

• Change in Biochemical Parameters

  Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)

Study Arms (2)

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.

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.

Behavioral: TELEREHABILITATION-NO

Interventions

TELEREHABILITATION-YES BEHAVIORAL

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-YES (Intervention Group)

TELEREHABILITATION-NO BEHAVIORAL

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.

TELEREHABILITATION-NO (Control Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Hospital University San Giovanni di Dio e Ruggi d'Aragona

Salerno, Italy

RECRUITING

Related Publications (13)

• 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.

  PMID: 35363499 RESULT

• 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.

  PMID: 34458905 RESULT

• 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.

  PMID: 35570817 RESULT

• 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.

  PMID: 26578683 RESULT

• 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.

  PMID: 36905176 RESULT

• 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.

  PMID: 19351942 RESULT

• 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.

  PMID: 30922474 RESULT

• 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.

  PMID: 31302050 RESULT

• 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.

  PMID: 34447992 RESULT

• 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.

  PMID: 36614865 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 40868691 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

The study will collect and retain the following biospecimens from participants for clinical and research purposes: Types of Samples Retained: Blood Samples * Plasma and serum - for analysis of biochemical markers related to chronic heart failure (e.g., B-type Natriuretic Peptide \[BNP\], N-terminal pro-B-type Natriuretic Peptide \[NT-proBNP\], creatinine, electrolytes, glucose, and lipid profile) * Urine Samples - To assess kidney function and electrolyte balance. All biospecimens will be pseudo-anonymized and stored securely following ethical guidelines (EU GDPR 2016/679) and institutional biobank policies. Participants will provide specific informed consent for sample retention and potential future research.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Alessia Bramanti, Electronic Engineering

CONTACT

+393483809181; abramanti@unisa.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 17, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)