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Heart FailureVIRTUAL-HFNCT06115928

Effects of Virtual Reality on Rehabilitation in Patients With Heart Failure

A study testing Virtual reality in people with Heart Failure and Reduced Ejection Fraction, run by Valentina Micheluzzi at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Heart Failure, Reduced Ejection Fraction
What is being tested?
Virtual reality
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteItaly
Study dates
1 Dec 2023to 30 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age over 18 years;
  • clinically stable chronic HF diagnosis with left ventricular ejection fraction (LVEF) < 40%

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Valentina Micheluzzi

    Sassari, 07100

    Valentina Micheluzzi, MSN, RN, 3401753630, valentina.micheluzzi@aouss.it

Other trials in Italy

About this study

Official title: Effects of VIRTUal reALity on Rehabilitation in Patients With Heart Failure: a Protocol for a Randomized Controlled Trial

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.

Read more

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.

Being tested
Virtual reality
Keywords
heart failure, cardiac rehabilitation, virtual reality, treatment adherence and compliance, randomized controlled trial
Medical subject headings
Heart Failure, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual realityDevice

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

Study groups in NCT06115928
Study groupRoleWhat they receive
interventional groupExperimentalPatients will undergo cardiac rehabilitation for 30-minute each sessions, twice a week for one month with virtual reality.
Receives: Device: Virtual reality
control groupNo interventionPatients will undergo cardiac rehabilitation for 30-minute each sessions, twice a week for one month on standard care (without virtual reality)

What is being measured

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

  1. adherence to cardiac rehabilitation

    adherence to cardiac rehabilitation measured as the number of sessions performed, compared to the scheduled sessions expressed as a percentage

    Measured: after 4 weeks

Secondary outcomes (12)

  1. Functional capacity

    functional capacity in meters with the six minutes walking test

    Measured: at baseline, after 4 and 8 weeks

  2. 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.

    Measured: at baseline, after 4 and 8 weeks

  3. 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).

    Measured: at baseline, after 4 and 8 weeks

  4. heart rate

    digital monitor

    Measured: at baseline, after 4 and 8 weeks

  5. blood pressure

    digital monitor

    Measured: at baseline, after 4 and 8 weeks

  6. oxygen saturation

    digital monitor

    Measured: at baseline, after 4 and 8 weeks

  7. Maximal oxygen uptake

    CPET parameters

    Measured: at baseline and after 8 weeks

  8. Minute ventilation/carbon dioxide production slope

    CPET parameters

    Measured: at baseline and after 8 weeks

  9. oxygen pulse

    CPET parameters

    Measured: at baseline and after 8 weeks

  10. NT-probnp

    blood values

    Measured: at baseline and after 8 weeks

  11. HF-related rehospitalization

    number of rehopedalization related to heart failure

    Measured: after 8 weeks from the stard of the study

  12. 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.

    Measured: at baseline, after 4 and 8 weeks

Timeline

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

  1. First posted3 Nov 2023
  2. Study start1 Dec 2023 (estimated)
  3. Primary completion30 Nov 2024 (estimated)
  4. Study completion30 Nov 2024 (estimated)

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06115928
Sponsor's protocol ID
AOSassari
Acronym
VIRTUAL-HF
Status last verified
Oct 2023
First submitted
25 Oct 2023
Last updated
3 Nov 2023
Results posted
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

  • 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.

    PubMed 21996391

  • 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.

    PubMed 24627449

  • 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

  • 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.

    PubMed 10918932

  • 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.

    PubMed 29909641

  • 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.

  • 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.

    PubMed 17553159

  • 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.

    PubMed 23684867

  • 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.

    PubMed 31045610

  • 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.

    PubMed 29138050

  • 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.

    PubMed 32682439

  • 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.

    PubMed 36301514

  • 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.

    PubMed 34130713

  • 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.

    PubMed 31623622

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality in people with Heart Failure and Reduced Ejection Fraction, run by Valentina Micheluzzi 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Nov 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

adherence to cardiac rehabilitation (time frame: after 4 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 NCT06115928, which also lists 28 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 3 Nov 2023.

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