MOVE: Sensation of Dyspnea and Experience of Patients With Heart Failure

Sponsor
Hospital de Clinicas de Porto Alegre (Other)
Overall Status
Recruiting
CT.gov ID
NCT05596292
Collaborator
Federal University of Rio Grande do Sul (Other)
66
1
2
24
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Immersive Virtual Reality glasses
  • Other: early mobilization protocol
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single-center randomized parallel controlled trialSingle-center randomized parallel controlled trial
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  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]

    Assessment of patient experience using the Net Promoter Score, Likert and Analogical Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de Clinicas de Porto Alegre Porto Alegre RS Brazil 90035003

Sponsors and Collaborators

  • Hospital de Clinicas de Porto Alegre
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT05596292
Other Study ID Numbers:
  • 2022-0355
First Posted:
Oct 27, 2022
Last Update Posted:
Dec 5, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital de Clinicas de Porto Alegre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2022