Decompensated Heart FailureMOVENCT05596292
Sensation of Dyspnea and Experience of Patients With Heart Failure
A study testing Immersive Virtual Reality glasses and early mobilization protocol in people with Decompensated Heart Failure, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Heart Failure
- What is being tested?
- Immersive Virtual Reality glasses and early mobilization protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being hospitalized for 24 hours or more
- Diagnosis of acute heart failure decompensated
- Being lucid and colaborative
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035003
Eneida R Rabelo da Silva, Professor, 55 51 33598084, eneidarabelo@gmail.com
Eneida R Rabelo da Silva, RN,ScD
About this study
Official title: 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.
Read the 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.
- Conditions
- Decompensated Heart Failure
- Being tested
- Immersive Virtual Reality glasses, early mobilization protocol
- Keywords
- Early Mobilization, Cardiac Rehabilitation, Virtual reality, Exercise Tolerance, Patient experience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality glassesDevice
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 protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: early mobilization protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Assessment of patient experience using the Net Promoter Score, Likert and Analogical Scale
Measured: Within 48 hours after the end of the early mobilization protocol with and without immersive virtual reality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Decompensated Heart FailureStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center randomized parallel controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Eneida R Rabelo Silva, RN, MSc, ScD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596292
- Sponsor's protocol ID
- 2022-0355
- Acronym
- MOVE
- Status last verified
- Dec 2022
- First submitted
- 7 Oct 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Mobilization and experience data
Publications
Fraga IB, Caballero LG, Tremea CEM, Prates JDS, Perin G, Guedes VA, Lago PD, Rabelo-Silva ER. Effects, Feasibility, and Safety of an Early Mobilization Protocol With Immersive Virtual Reality for Dyspnea in Patients With Acutely Decompensated Heart Failure: The MOVE Randomized Clinical Trial. JMIR Form Res. 2025 Oct 31;9:e80729. doi: 10.2196/80729.
PubMed 41172284Caballero 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.
PubMed 40955916Fraga 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.
PubMed 38001540
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensation of Dyspnea and Experience of Patients With Decompensated Heart Failure Undergoing an Early Mobilization Protocol With Immersive Virtual Reality: a Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT05596292
- Acronym / sponsor ID
- MOVE / 2022-0355
- Conditions
- Decompensated Heart Failure
- Keywords
- Early Mobilization, Cardiac Rehabilitation, Virtual reality, Exercise Tolerance, Patient experience
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center randomized parallel controlled trial
| Arm | Type | Receives |
|---|---|---|
| early mobilization protocol and immersive virtual reality | Experimental | Device: Immersive Virtual Reality glasses, Other: early mobilization protocolThree 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. |
| early mobilization protocol | Active comparator | Other: early mobilization protocolThree 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being hospitalized for 24 hours or more
- Diagnosis of acute heart failure decompensated
- Being lucid and colaborative
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual Reality glassesThe 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 | early mobilization protocol and immersive virtual reality |
| early mobilization protocolThree 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, early mobilization protocol and immersive virtual reality |
Primary outcome
Change from baseline sensation of dyspnea on the Borg Rating Of Perceived Exertion Scale at immediately post-intervention
Time frame: Up to 3 minutes before and up to 3 minutes after the early mobilization protocol with and without immersive virtual reality
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
1 secondary outcome
Patient experience with and without immersive virtual reality during mobilization
Time frame: Within 48 hours after the end of the early mobilization protocol with and without immersive virtual reality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Derived from this study: PubMed 41172284Fraga IB, Caballero LG, Tremea CEM, Prates JDS, Perin G, Guedes VA, Lago PD, Rabelo-Silva ER. Effects, Feasibility, and Safety of an Early Mobilization Protocol With Immersive Virtual Reality for Dyspnea in Patients With Acutely Decompensated Heart Failure: The MOVE Randomized Clinical Trial. JMIR Form Res. 2025 Oct 31;9:e80729. doi: 10.2196/80729.
- Derived from this study: PubMed 40955916Caballero 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.
- Derived from this study: PubMed 38001540Fraga 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.
- Individual participant dataSharing planned: Yes. Mobilization and experience data
Related trials for Decompensated Heart Failure
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
Acute Decompensated Heart Failure (ADHF)
Recruiting
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eneida R Rabelo Silva, RN, MSc, ScD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality glasses and early mobilization protocol in people with Decompensated Heart Failure, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eneida R Rabelo Silva, RN, MSc,ScD (55 51998068616, eneidarabelo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline sensation of dyspnea on the Borg Rating Of Perceived Exertion Scale at immediately post-intervention (time frame: Up to 3 minutes before and up to 3 minutes after the early mobilization protocol with and without immersive virtual reality). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05596292, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.