Sensation of Dyspnea and Experience of Patients With Heart Failure (MOVE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Decompensated Heart Failure
• Intervention / Treatment: Device: Immersive Virtual Reality glasses; Other: early mobilization protocol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eneida R Rabelo Silva, RN, MSc,ScD; Phone Number: 55 51998068616; Email: eneidarabelo@gmail.com

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90035003
      • Recruiting
      • Hospital de Clínicas de Porto Alegre
      • Contact: Eneida R Rabelo da Silva, Professor; Phone Number: 55 51 33598084; Email: eneidarabelo@gmail.com
      • Principal Investigator: Eneida R Rabelo da Silva, RN,ScD
      • Sub-Investigator: Pedro D Lago, ScD
      • Sub-Investigator: João Lucas C Oliveira, RN,ScD
      • Sub-Investigator: Larissa G Caballero, RN
      • Sub-Investigator: Iasmin B Fraga
      • Sub-Investigator: Mauren P Haeffner
      • Sub-Investigator: Marina S Santos, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient experience with and without immersive virtual reality during mobilization	Assessment of patient experience using the Net Promoter Score, Likert and Analogical Scale	Within 48 hours after the end of the early mobilization protocol with and without immersive virtual reality

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Federal University of Rio Grande do Sul
• Investigators: Principal Investigator: Eneida R Rabelo Silva, RN, MSc, ScD, Federal University of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Virtual reality; Cardiac Rehabilitation; Exercise Tolerance; Early Mobilization; Patient experience
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Heart Failure; Dyspnea
• Other Study ID Numbers: 2022-0355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Mobilization and experience data
• IPD Sharing Time Frame: Study Protocol when published
• IPD Sharing Access Criteria: When available
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No