Sensation of Dyspnea and Experience of Patients With Heart Failure

NCT05596292 | Unknown DMC

• 1 other identifier: 2022-0355
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Decompensated Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline sensation of dyspnea on the Borg Rating Of Perceived Exertion Scale at immediately post-intervention

  The 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

  Up to 3 minutes before and up to 3 minutes after the early mobilization protocol with and without immersive virtual reality

Secondary Outcomes (1)

• Patient experience with and without immersive virtual reality during mobilization

  Within 48 hours after the end of the early mobilization protocol with and without immersive virtual reality

Study Arms (2)

early mobilization protocol and immersive virtual reality

EXPERIMENTAL

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.

Device: Immersive Virtual Reality glasses; Other: early mobilization protocol

early mobilization protocol

ACTIVE COMPARATOR

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.

Other: early mobilization protocol

Interventions

Immersive Virtual Reality glasses 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 and immersive virtual reality

early mobilization protocol 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; early mobilization protocol and immersive virtual reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being hospitalized for 24 hours or more
• Diagnosis of acute heart failure decompensated
• Being lucid and colaborative

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

RECRUITING

Related Publications (2)

• 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.

  PMID: 40955916 DERIVED

• 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.

  PMID: 38001540 DERIVED

Study Officials

• Eneida R Rabelo Silva, RN, MSc, ScD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eneida R Rabelo Silva, RN, MSc,ScD

CONTACT

55 51998068616; eneidarabelo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center randomized parallel controlled trial

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 27, 2022
• Study Start: December 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2024
• Last Updated: December 5, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Study Protocol when published
• Access Criteria: When available

Locations

BR (1)