Clinical trial NCT07023536: Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure
Official title: Evaluation of the Effectiveness of a Cardiac Telerehabilitation Program in Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure
Keywords: Chronic Heart Failure
Cardiac Rehabilitation
Tele-rehabilitation
Telemedicine
Exercise Training
Remote Monitoring
mHealth
Wearable Sensors
Home-based Rehabilitation
Digital Health
Lead sponsor: University of Salerno
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
First posted: 2025-06-17
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 18 years or older with a diagnosis of chronic heart failure (HFrEF, HFmrEF, or HFpEF), NYHA class I-III, referred for cardiac rehabilitation at a tertiary care center. Participants must be clinically stable, on optimal medical therapy, and able to participate in either an in-person or home-based telerehabilitation program. Digital literacy (of the patient or caregiver) is required for inclusion in the telerehabilitation group. Both sexes are included. Patients with severe comorbidities limiting life expectancy or with NYHA class IV heart failure are excluded.

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.

Detailed description: This is a prospective, single-center, non-pharmacological observational study designed to assess the effectiveness of a structured home-based cardiac tele-rehabilitation program in patients with chronic heart failure (CHF). The study aims to determine whether tele-rehabilitation is comparable or superior to standard in-hospital cardiac rehabilitation in improving patients' functional capacity, as measured by peak oxygen uptake (VO₂ max), and secondary health-related outcomes.

Participants will be adults diagnosed with CHF, already on optimized medical therapy, and eligible for cardiac rehabilitation. Based on their voluntary choice, they will be allocated to either a tele-rehabilitation group or a conventional in-hospital rehabilitation group. Both groups will follow the same 8-week exercise training protocol, which includes interval and endurance components based on international guidelines. However, the tele-rehabilitation group will perform the program at home using a certified telemonitoring platform and wearable sensors, under real-time remote supervision by physiotherapists.

Data collection will include clinical, functional, biochemical, and quality-of-life assessments at multiple time points (baseline, 4, 8, 16, and 24 weeks). The primary outcome is the change in VO₂ max at 8 weeks. Secondary outcomes include changes in echocardiographic parameters, exercise tolerance, biomarkers (e.g., BNP, ANP), and quality-of-life scores (e.g., SF-36, KCCQ-12), as well as maintenance of functional gains at follow-up.

The study also evaluates adherence, safety, and usability of the tele-rehabilitation system. No experimental drugs or additional diagnostic procedures beyond standard care are involved. The findings will inform the integration of tele-rehabilitation into standard CHF management and support scalable care models for chronic disease.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of chronic heart failure for at least 6 months, with stable optimal medical therapy for at least 1 month
* NYHA 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in VO₂max from baseline to 8 weeks
timeFrame: Baseline (T=0) and end of intervention (T=2, 8 weeks)
Secondary outcomes:
measure: VO₂max at 24-week follow-up
timeFrame: follow-up (T=4, 24 weeks)
measure: Change in functional capacity assessed by 6-minute walk test (6MWT)
timeFrame: Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
measure: Change in Quality of Life
timeFrame: Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
measure: Change in Quality of Life
timeFrame: Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
measure: Change in Biochemical Parameters
timeFrame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
measure: Change in Biochemical Parameters
timeFrame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
measure: Change in Biochemical Parameters
timeFrame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
measure: Change in Biochemical Parameters
timeFrame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
measure: Change in Biochemical Parameters
timeFrame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
measure: Change in Biochemical Parameters
timeFrame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
measure: Change in Biochemical Parameters
timeFrame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
measure: Change in Functional ECG-Derived Parameters
timeFrame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
measure: Change in Functional ECG-Derived Parameters
timeFrame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
measure: Change in Functional Echocardiographic derived Parameters
timeFrame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
measure: Change in Functional Echocardiographic derived Parameters
timeFrame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
measure: Change in Functional Echocardiographic derived Parameters
timeFrame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
measure: Change in Functional Echocardiographic derived Parameters
timeFrame: Baseline (T=0), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
measure: Change in cognitive function assessed by Mini-Mental State Examination (MMSE)
timeFrame: Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
measure: Change in physical performance assessed by Short Physical Performance Battery (SPPB)
timeFrame: Baseline (T=0), 4 weeks (T=1), 8 weeks (T=2), 16 weeks (T=3), 24 weeks (T=4)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.