Sensation of Dyspnea and Experience of Patients With Heart Failure

NCT ID: NCT05596292

Last Updated: 2022-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-12-01

Brief Summary

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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

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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.

Conditions

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Decompensated Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center randomized parallel controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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early mobilization protocol and immersive virtual reality

Three days of an early mobilization protocol using immersive virtual reality glasses. 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. 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.

Group Type EXPERIMENTAL

Immersive Virtual Reality glasses

Intervention Type DEVICE

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.

early mobilization protocol

Intervention Type OTHER

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.

early mobilization protocol

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.

Group Type ACTIVE_COMPARATOR

early mobilization protocol

Intervention Type OTHER

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.

Interventions

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Immersive 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.

Intervention Type DEVICE

early mobilization protocol

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Rio Grande do Sul

OTHER

Sponsor Role collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eneida R Rabelo Silva, RN, MSc, ScD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

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Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Eneida R Rabelo Silva, RN, MSc,ScD

Role: CONTACT

55 51998068616

Facility Contacts

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Eneida R Rabelo da Silva, Professor

Role: primary

55 51 33598084

References

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Caballero LG, Fraga IB, Tremea CEM, Perin G, Prates JDS, Lago PD, Oliveira JLC, Rabelo-Silva ER. Experience of heart failure patients in mobilization with virtual reality: mixed methods study. Rev Esc Enferm USP. 2025 Sep 15;59:e20250114. doi: 10.1590/1980-220X-REEUSP-2025-0114en. eCollection 2025.

Reference Type DERIVED
PMID: 40955916 (View on PubMed)

Fraga IB, Caballero LG, Lago PD, de Oliveira JLC, Scherer M, Haeffner MP, Rabelo-Silva ER. Perceived dyspnea and experience of hospitalized patients with acute decompensated heart failure undergoing an early MObilization protocol with immersive Virtual rEality: MOVE study protocol for a parallel superiority randomized clinical trial. Trials. 2023 Nov 24;24(1):751. doi: 10.1186/s13063-023-07786-z.

Reference Type DERIVED
PMID: 38001540 (View on PubMed)

Other Identifiers

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2022-0355

Identifier Type: -

Identifier Source: org_study_id

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