Sensation of Dyspnea and Experience of Patients With Heart Failure

Study Overview
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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.

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

Conditions
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Decompensated Heart Failure

Intervention / Treatment
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* Device: Immersive Virtual Reality glasses
* Other: early mobilization protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-center randomized parallel controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early mobilization protocol and immersive virtual reality<br>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<br>* 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.<br>Other: early mobilization protocol<br>* 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.<br>|
| Active Comparator: early mobilization protocol<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Mobilization, Cardiac Rehabilitation, Virtual reality, Exercise Tolerance, Patient experience