Virtual Reality Based-therapy Applied to Physical Therapy in Cardiology.
2 août 2019 mis à jour par: Ana Laura Ricci-Vitor, Universidade Estadual Paulista Júlio de Mesquita Filho
The aim of this study is to investigate engagement, motivation, and the barriers to adherence of virtual reality based therapy (VRBT) in patients with cardiac diseases and risk factors to the development of cardiac diseases.
In addition, to investigate autonomic and hemodynamic responses of VRBT in comparison with conventional therapy (CT).
To do this, patients with cardiac diseases or risk factors will be invited to perform CT or VRBT+CT.
They will be submitted to an initial evaluation, and then will be random allocated to 12 weeks of intervention and to a final evaluation.
The primary outcomes includes engagement, motivation, barriers and adherence in the 12 previous weeks using questionnaire, after 12 weeks of the intervention and after 12 weeks of the final intervention program.
Hemodynamic and autonomic responses will be considered the secondary outcomes being evaluated before, during and after a session at the first, sixth and twelfth week.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Introduction: cardiovascular rehabilitation programs (CR) can promote several benefits in patients with cardiac diseases.
However, there are problems related to the patient adherence in CR.
Some of these problems can be caused to factors like motivation.
Alternative therapies can improve motivation and increase adherence to CR.
In this context, virtual reality based therapy (VRBT), have shown benefits in cardiac patients to pain relief, functional capacity and increasing physical activity levels, but there is no answer whether it can increase engagement and adherence to CR.
In addition, it is important to investigate hemodynamic responses of VRBT.
Objective: investigate engagement, motivation, and the barriers to adherence of VRBT in patients with cardiac diseases and risk factors to the development of cardiac diseases.
In addition, to investigate autonomic and hemodynamic responses of VRBT in comparison with conventional therapy (CT).
Methods: patients with cardiac diseases or risk factors will be invited to perform CT or VRBT+CT.
They will be submitted to an initial evaluation, the intervention and to a final evaluation.
The initial evaluation include eligibility investigation, and after they will be random allocated to the interventions.
The interventions will be performed with a frequency of three times a week, for 12 weeks, and the intensity will be prescribed individually.
The primary outcomes includes engagement, motivation, barriers and adherence in the 12 previous weeks according to a recall questionnaire, after 12 weeks of the intervention and after 12 weeks of the final intervention program.
The engagement will be evaluated using the User Engagement Scale (modified).
Motivation will be evaluated using the intrinsic motivation questionnaire.
The barriers will be evaluated using the Barriers Scale of Cardiac Rehabilitation.
Adherence will be evaluated using the presence in the patient's records.
Hemodynamic responses will be evaluated before, during and after a session at the first, sixth and twelfth week using blood pressure, heart rate, respiratory rate, oxygen saturation and rating of perceived exertion.
Autonomic responses will be evaluated using heart rate variability.
Statistical analysis: the data analysis will be evaluated using the two way ANOVA with Bonferroni posttest with significance to p < 0.05.
Type d'étude
Interventionnel
Inscription (Réel)
68
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
São Paulo
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Presidente Prudente, São Paulo, Brésil, 19060900
- Laboratório de Fisiologia do Estresse
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
16 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Patients with cardiovascular diseases
- Patients with risk factors to develop cardiovascular diseases
Exclusion Criteria:
- Patients who disagree to participate of any protocol interventions
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Conventional therapy
Exercise-based cardiac rehabilitation
|
Both interventions uses exercises
|
|
Expérimental: Virtual reality based therapy
Exercise-based virtual reality
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Both interventions uses exercises
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Engagement
Délai: Change from baseline at 12 weeks
|
Measured using the Utrecht engagement scale modified There is 17 items scored from 1 to 7, according to the Likert Scale.
Then, each item is summed and divided for the number of items.
Higher values represent a better engagement.
|
Change from baseline at 12 weeks
|
|
Motivation
Délai: Change from baseline at 12 weeks
|
Measured using the Intrinsic motivation inventory There is 18 items scored from 1 to 5, according to the Likert Scale.
Then, each item is summed and divided for the number of items.
Higher values represent a better motivation.
|
Change from baseline at 12 weeks
|
|
Barriers to Cardiac Rehabilitation
Délai: Change from baseline at 12 weeks
|
Measured using Cardiac Rehabilitation Barriers Scale There is 21 items score from 1 to 5, according to the Likert Scale.
Then, each item is summed and divided for the number of items.
Higher values represent a worse outcome.
In addition, there is four subscales: 1) Perceived need/health care factors, 2) Logistical factors, 3) Work/time conflicts, and 4) Comorbidities/functional status.
The subscales are scored in the same way of the total, it means, from 1 to 5 and them dividing from the total number of the items included in the subscale.
|
Change from baseline at 12 weeks
|
|
Adherence to Cardiac Rehabilitation
Délai: Change from baseline at 12 weeks
|
Measured using the number of cardiac rehabilitation sessions attended
|
Change from baseline at 12 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Autonomic responses
Délai: Up to 12 weeks
|
Measured using heart rate variability The heart rate variability will be measured through the following linear indices (SDNN: the standard deviation of normal-to-normal intervals, ms; rMSSD: the root mean square of successive difference between normal intervals,ms; RRtri: triangular index, based on RR intervals,ms; TINN: triangular interpolation of the normal to normal interval between consecutive heart beats, ms; LF: low frequency, nu; HF: high frequency and nonlinear indices,nu.).
In addition the nonlinear indices will be measured (SD1: standard deviation of instant variability beat to beat; SD2: standard deviation of long-term interval between consecutive heart beats).
In general higher values represent a better autonomic response.
|
Up to 12 weeks
|
|
Blood pressure
Délai: Up to 12 weeks
|
Measured using both systolic blood pressure and diastolic blood pressure
|
Up to 12 weeks
|
|
Heart rate
Délai: Up to 12 weeks
|
Measured using an equipment validated for recording heart rate beat to beat
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Up to 12 weeks
|
|
Respiratory rate
Délai: Up to 12 weeks
|
Measured using the number of respiratory incursions in one minute
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Up to 12 weeks
|
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Oxygen Saturation
Délai: Up to 12 weeks
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Measured using an oximeter
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Up to 12 weeks
|
|
Perceived exertion
Délai: Up to 12 weeks
|
Measured using Borg Scale.
This scale varies from 6 to 20.
|
Up to 12 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Ana Laura Ricci-Vitor, PhD, Universidade Estadual Paulista Júlio de Mesquita Filho
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- da Cruz MMA, Ricci-Vitor AL, Borges GLB, da Silva PF, Turri-Silva N, Takahashi C, Grace SL, Vanderlei LCM. A Randomized, Controlled, Crossover Trial of Virtual Reality in Maintenance Cardiovascular Rehabilitation in a Low-Resource Setting: Impact on Adherence, Motivation, and Engagement. Phys Ther. 2021 May 4;101(5). pii: pzab071. doi: 10.1093/ptj/pzab071.
- Alves da Cruz MM, Ricci-Vitor AL, Bonini Borges GL, Fernanda da Silva P, Ribeiro F, Marques Vanderlei LC. Acute Hemodynamic Effects of Virtual Reality-Based Therapy in Patients of Cardiovascular Rehabilitation: A Cluster Randomized Crossover Trial. Arch Phys Med Rehabil. 2020 Apr;101(4):642-649. doi: 10.1016/j.apmr.2019.12.006. Epub 2020 Jan 8.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
19 décembre 2017
Achèvement primaire (Réel)
1 décembre 2018
Achèvement de l'étude (Réel)
3 juin 2019
Dates d'inscription aux études
Première soumission
6 novembre 2017
Première soumission répondant aux critères de contrôle qualité
13 décembre 2017
Première publication (Réel)
19 décembre 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 août 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 août 2019
Dernière vérification
1 août 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NCT400579/2017-0
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Description du régime IPD
After published results,
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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