Effects of Virtual Reality on Rehabilitation in Patients With Heart Failure (VIRTUAL-HF)

October 30, 2023 updated by: Valentina Micheluzzi

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: interventional group
Patients will undergo cardiac rehabilitation for 30-minute each sessions, twice a week for one month with virtual reality.
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®.
No Intervention: control group
Patients will undergo cardiac rehabilitation for 30-minute each sessions, twice a week for one month on standard care (without virtual reality)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adherence to cardiac rehabilitation
Time Frame: after 4 weeks
adherence to cardiac rehabilitation measured as the number of sessions performed, compared to the scheduled sessions expressed as a percentage
after 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional capacity
Time Frame: at baseline, after 4 and 8 weeks
functional capacity in meters with the six minutes walking test
at baseline, after 4 and 8 weeks
Perceived exertion
Time Frame: at baseline, after 4 and 8 weeks
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
Angina
Time Frame: at baseline, after 4 and 8 weeks
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
heart rate
Time Frame: at baseline, after 4 and 8 weeks
digital monitor
at baseline, after 4 and 8 weeks
blood pressure
Time Frame: at baseline, after 4 and 8 weeks
digital monitor
at baseline, after 4 and 8 weeks
oxygen saturation
Time Frame: at baseline, after 4 and 8 weeks
digital monitor
at baseline, after 4 and 8 weeks
Maximal oxygen uptake
Time Frame: at baseline and after 8 weeks
CPET parameters
at baseline and after 8 weeks
Minute ventilation/carbon dioxide production slope
Time Frame: at baseline and after 8 weeks
CPET parameters
at baseline and after 8 weeks
oxygen pulse
Time Frame: at baseline and after 8 weeks
CPET parameters
at baseline and after 8 weeks
NT-probnp
Time Frame: at baseline and after 8 weeks
blood values
at baseline and after 8 weeks
HF-related rehospitalization
Time Frame: after 8 weeks from the stard of the study
number of rehopedalization related to heart failure
after 8 weeks from the stard of the study
Quality of life of patients with heart failure
Time Frame: at baseline, after 4 and 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valentina Micheluzzi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 3, 2023

Study Record Updates

Last Update Posted (Actual)

November 3, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOSassari

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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