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A combination of multimodal physical exercises in real and virtual environments for individuals after chronic stroke: study protocol for a randomized controlled trial

BACKGROUND: Multimodal physical exercises already have well-established benefits for the post-stroke population that influence gait functional capacity, balance, gait, cognition, and quality of life. This type of intervention can be performed in both real and virtual environments. Considering the ch...

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Autores principales: Mazzini, Natalia Araujo, Almeida, Murilo Groschitz Ruas, Pompeu, José Eduardo, Polese, Janaine Cunha, Torriani-Pasin, Camila
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6636041/
https://www.ncbi.nlm.nih.gov/pubmed/31311595
http://dx.doi.org/10.1186/s13063-019-3396-2
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author Mazzini, Natalia Araujo
Almeida, Murilo Groschitz Ruas
Pompeu, José Eduardo
Polese, Janaine Cunha
Torriani-Pasin, Camila
author_facet Mazzini, Natalia Araujo
Almeida, Murilo Groschitz Ruas
Pompeu, José Eduardo
Polese, Janaine Cunha
Torriani-Pasin, Camila
author_sort Mazzini, Natalia Araujo
collection PubMed
description BACKGROUND: Multimodal physical exercises already have well-established benefits for the post-stroke population that influence gait functional capacity, balance, gait, cognition, and quality of life. This type of intervention can be performed in both real and virtual environments. Considering the characteristics of both environments, it is questioned to what extent the combination of interventions in real and virtual environments could result in improvement in post-stroke impairments. METHODS/DESIGN: We will conduct a randomized clinical trial with three groups: a real multimodal group (RMG), a virtual multimodal group (VMG), and a combined multimodal group (CMG). It was estimated that we will need a sample of 36 participants (12 per group). RMG individuals will only perform multimodal physical exercises in a real environment two times per week for 60 min per session for 15 weeks. VMG individuals will perform exercises of the same duration over the same time frame but only in a virtual environment. CMG individuals will hold a weekly session in a real environment and another weekly session in virtual environment. The primary outcome measure will be health-related quality of life, evaluated using the Stroke Impact Scale; effects on cognition (Montreal Cognitive Assessment), balance (Berg Balance Scale), mobility (Timed Up & Go), self-selected gait speed (10-meter walk test), and gait functional capacity (6-min walk test) will be investigated as secondary outcome measures. Participants will be evaluated before the beginning of the intervention, immediately after the end of the intervention, and at 1-month follow-up without exercise. If the data meet the assumptions of the parametric analysis, the results will be evaluated by analysis of variance (3 × 3) for the group factor, with repeated measures while taking into account the time factor. The post hoc Tukey test will be used to detect differences (α = 0.05). DISCUSSION: This study represents the first clinical trial to include three groups considering physical exercise in real and virtual environments, isolated and combined, that counterbalances the intensity and volume of training in all groups. This study also includes a control of progression in all groups along the 15-week intervention. The outcome measures are innovative because, according to International Classification of Functioning, Disability and Health, activity and participation are the targets for effectiveness evaluation. TRIAL REGISTRATION: Combinação de exercícios físicos multimodais em ambientes real e virtual para indivíduos pós acidente vascular cerebral crônico, RBR-4pt72m. Registered on 29 August 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3396-2) contains supplementary material, which is available to authorized users.
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spelling pubmed-66360412019-07-25 A combination of multimodal physical exercises in real and virtual environments for individuals after chronic stroke: study protocol for a randomized controlled trial Mazzini, Natalia Araujo Almeida, Murilo Groschitz Ruas Pompeu, José Eduardo Polese, Janaine Cunha Torriani-Pasin, Camila Trials Study Protocol BACKGROUND: Multimodal physical exercises already have well-established benefits for the post-stroke population that influence gait functional capacity, balance, gait, cognition, and quality of life. This type of intervention can be performed in both real and virtual environments. Considering the characteristics of both environments, it is questioned to what extent the combination of interventions in real and virtual environments could result in improvement in post-stroke impairments. METHODS/DESIGN: We will conduct a randomized clinical trial with three groups: a real multimodal group (RMG), a virtual multimodal group (VMG), and a combined multimodal group (CMG). It was estimated that we will need a sample of 36 participants (12 per group). RMG individuals will only perform multimodal physical exercises in a real environment two times per week for 60 min per session for 15 weeks. VMG individuals will perform exercises of the same duration over the same time frame but only in a virtual environment. CMG individuals will hold a weekly session in a real environment and another weekly session in virtual environment. The primary outcome measure will be health-related quality of life, evaluated using the Stroke Impact Scale; effects on cognition (Montreal Cognitive Assessment), balance (Berg Balance Scale), mobility (Timed Up & Go), self-selected gait speed (10-meter walk test), and gait functional capacity (6-min walk test) will be investigated as secondary outcome measures. Participants will be evaluated before the beginning of the intervention, immediately after the end of the intervention, and at 1-month follow-up without exercise. If the data meet the assumptions of the parametric analysis, the results will be evaluated by analysis of variance (3 × 3) for the group factor, with repeated measures while taking into account the time factor. The post hoc Tukey test will be used to detect differences (α = 0.05). DISCUSSION: This study represents the first clinical trial to include three groups considering physical exercise in real and virtual environments, isolated and combined, that counterbalances the intensity and volume of training in all groups. This study also includes a control of progression in all groups along the 15-week intervention. The outcome measures are innovative because, according to International Classification of Functioning, Disability and Health, activity and participation are the targets for effectiveness evaluation. TRIAL REGISTRATION: Combinação de exercícios físicos multimodais em ambientes real e virtual para indivíduos pós acidente vascular cerebral crônico, RBR-4pt72m. Registered on 29 August 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3396-2) contains supplementary material, which is available to authorized users. BioMed Central 2019-07-16 /pmc/articles/PMC6636041/ /pubmed/31311595 http://dx.doi.org/10.1186/s13063-019-3396-2 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Mazzini, Natalia Araujo
Almeida, Murilo Groschitz Ruas
Pompeu, José Eduardo
Polese, Janaine Cunha
Torriani-Pasin, Camila
A combination of multimodal physical exercises in real and virtual environments for individuals after chronic stroke: study protocol for a randomized controlled trial
title A combination of multimodal physical exercises in real and virtual environments for individuals after chronic stroke: study protocol for a randomized controlled trial
title_full A combination of multimodal physical exercises in real and virtual environments for individuals after chronic stroke: study protocol for a randomized controlled trial
title_fullStr A combination of multimodal physical exercises in real and virtual environments for individuals after chronic stroke: study protocol for a randomized controlled trial
title_full_unstemmed A combination of multimodal physical exercises in real and virtual environments for individuals after chronic stroke: study protocol for a randomized controlled trial
title_short A combination of multimodal physical exercises in real and virtual environments for individuals after chronic stroke: study protocol for a randomized controlled trial
title_sort combination of multimodal physical exercises in real and virtual environments for individuals after chronic stroke: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6636041/
https://www.ncbi.nlm.nih.gov/pubmed/31311595
http://dx.doi.org/10.1186/s13063-019-3396-2
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