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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06115928
Other study ID # AOSassari
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date November 30, 2024

Study information

Verified date October 2023
Source Azienda Ospedaliero Universitaria di Sassari
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background. To improve symptoms and reduce poor outcomes related to heart failure (HF), international guidelines recommend cardiac rehabilitation (CR), particularly for those with a reduced ejection fraction. Unfortunately, patient adherence to rehabilitation programs remains suboptimal, with dropouts ranging from 15.4 to 63.3%. An innovative and promising intervention that could improve adherence to rehabilitation is virtual reality (VR). This study aims to evaluate the effects of VR in patients with HF undergoing CR in terms of adherence (primary outcome), functional capacity, perceived exertion, angina, quality of life, heart rate, oxygen saturation, blood pressure, maximum oxygen uptake, minute ventilation/carbon dioxide production slope, oxygen pulse, blood values of NT-proBNP and rehospitalization rates due to HF (secondary outcomes). Methods. A randomized controlled trial will be conducted in a sample of 80 patients referred to CR. Participants will be enrolled in a cardiological rehabilitation unit of a large university hospital in Italy and randomized (1:1) to the experimental intervention consisting of CR performed with high-quality immersive VR with PICO 4® Head Mounted Display headset and TREADMILL XR® software (Arm 1) or standard CR (Arm 2). Patients will receive 30-minute CR sessions twice a week for one month. Results. Significant improvements in primary and secondary outcomes are expected in patients in the intervention group. Conclusions. If proven to be effective, VR could be an innovative, safe, and easy digital health intervention to improve adherence to CR in patients with HF, as well as important clinical outcomes.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date November 30, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - age over 18 years; - clinically stable chronic HF diagnosis with left ventricular ejection fraction (LVEF) < 40% Exclusion Criteria: - conditions that exclude exercise training (e.g., bone fractures); - conditions that exclude VR use of VR (e.g., blindness and deafness - severe cognitive impairment, documented with a score of 0 - 4 on the Six-item Screener; - end-stage renal disease requiring dialysis; - ascertained advanced pneumopathies; - active neoplasms; - rheumatic diseases.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Virtual reality
Participants will perform cardiac rehabilitation with hardware-type technology consisting of a PICO 4® head mounted display (HMD) headset and the software TREADMILL XR®.

Locations

Country Name City State
Italy Valentina Micheluzzi Sassari

Sponsors (1)

Lead Sponsor Collaborator
Valentina Micheluzzi

Country where clinical trial is conducted

Italy, 

References & Publications (28)

Alfieri FM, da Silva Dias C, de Oliveira NC, Battistella LR. Gamification in Musculoskeletal Rehabilitation. Curr Rev Musculoskelet Med. 2022 Dec;15(6):629-636. doi: 10.1007/s12178-022-09797-w. Epub 2022 Oct 27. — View Citation

Basso Moro S, Bisconti S, Muthalib M, Spezialetti M, Cutini S, Ferrari M, Placidi G, Quaresima V. A semi-immersive virtual reality incremental swing balance task activates prefrontal cortex: a functional near-infrared spectroscopy study. Neuroimage. 2014 Jan 15;85 Pt 1:451-60. doi: 10.1016/j.neuroimage.2013.05.031. Epub 2013 May 17. — View Citation

Burrai F, Ortu S, Marinucci M, De Marinis MG, Piredda M. Effectiveness of Immersive Virtual Reality in People with Cancer Undergoing Antiblastic Therapy: A Randomized Controlled Trial. Semin Oncol Nurs. 2023 Aug;39(4):151470. doi: 10.1016/j.soncn.2023.151470. Epub 2023 Jul 16. — View Citation

Burrai F, Othman S, Brioni E, Micheluzzi V, Luppi M, Apuzzo L, Delli Zotti GB, La Manna G. Effects of Virtual Reality in Patients Undergoing Dialysis: Study Protocol. Holist Nurs Pract. 2019 Nov/Dec;33(6):327-337. doi: 10.1097/HNP.0000000000000330. — View Citation

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Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586. — View Citation

Cikajlo I, Peterlin Potisk K. Advantages of using 3D virtual reality based training in persons with Parkinson's disease: a parallel study. J Neuroeng Rehabil. 2019 Oct 17;16(1):119. doi: 10.1186/s12984-019-0601-1. — View Citation

Day ML, McGuigan MR, Brice G, Foster C. Monitoring exercise intensity during resistance training using the session RPE scale. J Strength Cond Res. 2004 May;18(2):353-8. doi: 10.1519/R-13113.1. — View Citation

Doumas I, Everard G, Dehem S, Lejeune T. Serious games for upper limb rehabilitation after stroke: a meta-analysis. J Neuroeng Rehabil. 2021 Jun 15;18(1):100. doi: 10.1186/s12984-021-00889-1. — View Citation

Dunbar-Jacob J, Erlen JA, Schlenk EA, Ryan CM, Sereika SM, Doswell WM. Adherence in chronic disease. Annu Rev Nurs Res. 2000;18:48-90. — View Citation

Edelmann F, Gelbrich G, Dungen HD, Frohling S, Wachter R, Stahrenberg R, Binder L, Topper A, Lashki DJ, Schwarz S, Herrmann-Lingen C, Loffler M, Hasenfuss G, Halle M, Pieske B. Exercise training improves exercise capacity and diastolic function in patients with heart failure with preserved ejection fraction: results of the Ex-DHF (Exercise training in Diastolic Heart Failure) pilot study. J Am Coll Cardiol. 2011 Oct 18;58(17):1780-91. doi: 10.1016/j.jacc.2011.06.054. — View Citation

Freeman D, Reeve S, Robinson A, Ehlers A, Clark D, Spanlang B, Slater M. Virtual reality in the assessment, understanding, and treatment of mental health disorders. Psychol Med. 2017 Oct;47(14):2393-2400. doi: 10.1017/S003329171700040X. Epub 2017 Mar 22. — View Citation

Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. doi: 10.1016/s0735-1097(00)00531-3. — View 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. 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. Erratum In: Circulation. 2022 May 3;145(18):e1033. Circulation. 2022 Sep 27;146(13):e185. Circulation. 2023 Apr 4;147(14):e674. — View Citation

Keshner EA, Weiss PT. Introduction to the special issue from the proceedings of the 2006 International Workshop on Virtual Reality in Rehabilitation. J Neuroeng Rehabil. 2007 Jun 6;4:18. doi: 10.1186/1743-0003-4-18. — View Citation

Long L, Anderson L, Dewhirst AM, He J, Bridges C, Gandhi M, Taylor RS. Exercise-based cardiac rehabilitation for adults with stable angina. Cochrane Database Syst Rev. 2018 Feb 2;2(2):CD012786. doi: 10.1002/14651858.CD012786.pub2. — View 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 — View Citation

Meijer HA, Graafland M, Goslings JC, Schijven MP. Systematic Review on the Effects of Serious Games and Wearable Technology Used in Rehabilitation of Patients With Traumatic Bone and Soft Tissue Injuries. Arch Phys Med Rehabil. 2018 Sep;99(9):1890-1899. doi: 10.1016/j.apmr.2017.10.018. Epub 2017 Nov 11. — View Citation

Nolte K, Herrmann-Lingen C, Wachter R, Gelbrich G, Dungen HD, Duvinage A, Hoischen N, von Oehsen K, Schwarz S, Hasenfuss G, Halle M, Pieske B, Edelmann F. Effects of exercise training on different quality of life dimensions in heart failure with preserved ejection fraction: the Ex-DHF-P trial. Eur J Prev Cardiol. 2015 May;22(5):582-93. doi: 10.1177/2047487314526071. Epub 2014 Mar 13. — View Citation

Pacheco TBF, de Medeiros CSP, de Oliveira VHB, Vieira ER, de Cavalcanti FAC. Effectiveness of exergames for improving mobility and balance in older adults: a systematic review and meta-analysis. Syst Rev. 2020 Jul 18;9(1):163. doi: 10.1186/s13643-020-01421-7. — View Citation

Resurreccion DM, Moreno-Peral P, Gomez-Herranz M, Rubio-Valera M, Pastor L, Caldas de Almeida JM, Motrico E. Factors associated with non-participation in and dropout from cardiac rehabilitation programmes: a systematic review of prospective cohort studies. Eur J Cardiovasc Nurs. 2019 Jan;18(1):38-47. doi: 10.1177/1474515118783157. Epub 2018 Jun 18. — View Citation

Savarese G, Becher PM, Lund LH, Seferovic P, Rosano GMC, Coats AJS. Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovasc Res. 2023 Jan 18;118(17):3272-3287. doi: 10.1093/cvr/cvac013. Erratum In: Cardiovasc Res. 20 — View 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. — View Citation

Uszko-Lencer NHMK, Mesquita R, Janssen E, Werter C, Brunner-La Rocca HP, Pitta F, Wouters EFM, Spruit MA. Reliability, construct validity and determinants of 6-minute walk test performance in patients with chronic heart failure. Int J Cardiol. 2017 Aug 1;240:285-290. doi: 10.1016/j.ijcard.2017.02.109. Epub 2017 Feb 28. — View Citation

Weiss PL, Kizony R, Feintuch U, Katz N. Virtual Reality in neurorehabilitation. In: Selzer M, Clarke S, Cohen L, Duncan P, Gage F, editors. Neural Repair and Rehabilitation. Cambridge; 2006. p. 182-97.

World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available. — View Citation

Xue J, Chiu HFK, Liang J, Zhu T, Jiang Y, Chen S. Validation of the Six-Item Screener to screen for cognitive impairment in primary care settings in China. Aging Ment Health. 2018 Apr;22(4):453-457. doi: 10.1080/13607863.2017.1280768. Epub 2017 Feb 1. — View Citation

* Note: There are 28 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary adherence to cardiac rehabilitation adherence to cardiac rehabilitation measured as the number of sessions performed, compared to the scheduled sessions expressed as a percentage after 4 weeks
Secondary Functional capacity functional capacity in meters with the six minutes walking test at baseline, after 4 and 8 weeks
Secondary Perceived exertion with Borg rating of perceived exertion which captures physical activity intensity levels related to heart rate during exercise. The rate is multiplied by 10 to determine the ideal heart rate during aerobic exercise. The Borg scale score ranges from 6 to 20 corresponding to "no effort" and "maximum effort", respectively, equating a minimum of 20% to a max of 100% effort. at baseline, after 4 and 8 weeks
Secondary Angina with Canadian Cardiovascular Society (CCS) grading of angina.The CCS classification system employs four grades ranging from I (no physical activity limitation) to IV (inability to perform any physical activity without discomfort). at baseline, after 4 and 8 weeks
Secondary heart rate digital monitor at baseline, after 4 and 8 weeks
Secondary blood pressure digital monitor at baseline, after 4 and 8 weeks
Secondary oxygen saturation digital monitor at baseline, after 4 and 8 weeks
Secondary Maximal oxygen uptake CPET parameters at baseline and after 8 weeks
Secondary Minute ventilation/carbon dioxide production slope CPET parameters at baseline and after 8 weeks
Secondary oxygen pulse CPET parameters at baseline and after 8 weeks
Secondary NT-probnp blood values at baseline and after 8 weeks
Secondary HF-related rehospitalization number of rehopedalization related to heart failure after 8 weeks from the stard of the study
Secondary Quality of life of patients with heart failure with Kansas City Cardiomyopathy Questionnaire (KCCQ) which consists of 23 items to assess physical function, symptoms, social function, self-efficacy and quality of life of patients. KCCQ scores range from 0 to 100 and the scores represent health status as follows: from 0 to 24, very poor to poor; 25 to 49, poor to fair; 50 to 74, fair to good; and 75 to 100, good to excellent. at baseline, after 4 and 8 weeks
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