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Sensation of Dyspnea and Experience of Patients With Heart Failure

Sensation of Dyspnea and Experience of Patients With Decompensated Heart Failure Undergoing an Early Mobilization Protocol With Immersive Virtual Reality: a Clinical Trial Protocol

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05596292
Acronym
MOVE
Enrollment
66
Registered
2022-10-27
Start date
2022-12-01
Completion date
2024-12-01
Last updated
2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decompensated Heart Failure

Keywords

Early Mobilization, Cardiac Rehabilitation, Virtual reality, Exercise Tolerance, Patient experience

Brief summary

This randomized clinical trial aims to evaluate patients with decompensated heart failure undergoing an early mobilization protocol with the use of immersive virtual reality glasses compared with patients undergoing the same protocol but without immersive virtual reality. The primary outcome will be the sensation of difficulty breathing, and the secondary outcome will be whether this technology provided a positive experience for patients in the intervention group that was superior to that of patients in the control group.

Detailed description

This randomized clinical trial aims to assess the sensation of dyspnea in patients undergoing an early mobilization protocol with immersive virtual reality and their experience using this technology. The study population consists of patients with acute decompensated heart failure in an intensive care unit at a teaching hospital. The 3-day protocol will include active exercises with an in-bed cycle ergometer, orthostasis, and ambulation. The intervention group will perform all exercises using virtual reality glasses. The variables will be collected before and after each intervention.

Interventions

DEVICEImmersive Virtual Reality glasses

The immersive virtual reality glasses support a smartphone device, allowing videos to be used with 360º rotation and earpods headphones with bluetooth for sound. Video options will be offered to participants according to the exercise performed, ie: a cycling video for activities with a cycle ergometer; video with people walking for ambulation; and videos of the patient's choice, such as forest, beach or city scenarios, for other moments.

Three days of an early mobilization protocol. The exercises will be progressed every day, starting in the first day with active movements of lower and upper limbs with cycle ergometer; in the second day repeat the first day exercise and do orthostasis training; and in the last day training ambulation.

Sponsors

Federal University of Rio Grande do Sul
CollaboratorOTHER
Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Single-center randomized parallel controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Patients with 18 years or older * Being hospitalized for 24 hours or more * Diagnosis of acute heart failure decompensated * Being lucid and colaborative

Exclusion criteria

* Mechanical ventilation or circulatory support * Neurodegenerative diseases * Pregnant patients * Hemodynamic instability at baseline * Score on the Borg Rating of Perceived Exertion Scale Borg ≥ 4 at rest * High risk of falls * Difficulty communicating * Not adapt with the immersive virtual reality glasses

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline sensation of dyspnea on the Borg Rating Of Perceived Exertion Scale at immediately post-interventionUp to 3 minutes before and up to 3 minutes after the early mobilization protocol with and without immersive virtual realityThe evaluation of dyspnea sensation using the Borg Rating Of Perceived Exertion Scale. This scale has a score ranging from zero to 10, and the higher the score the patient reports, the greater the sensation of dyspnea

Secondary

MeasureTime frameDescription
Patient experience with and without immersive virtual reality during mobilizationWithin 48 hours after the end of the early mobilization protocol with and without immersive virtual realityAssessment of patient experience using the Net Promoter Score, Likert and Analogical Scale

Countries

Brazil

Contacts

Primary ContactEneida R Rabelo Silva, RN, MSc,ScD
eneidarabelo@gmail.com55 51998068616

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026