Public trial
RBR-29vzr84 Breathing muscle strength training for movement of individuals with stroke
Date of registration: 03/20/2022 (mm/dd/yyyy)Last approval date : 03/20/2022 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
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Inspiratory muscle training in functionality and swallowing in individuals with stroke
pt-br
Treinamento muscular inspiratório na funcionalidade e deglutição em indivíduos com Acidente Vascular Cerebral
es
Inspiratory muscle training in functionality and swallowing in individuals with stroke
Trial identification
- UTN code: U1111-1272-5356
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Public title:
en
Breathing muscle strength training for movement of individuals with stroke
pt-br
Treinamento para força dos músculos da respiração para movimentação de indivíduos com derrame.
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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15885919.2.0000.5028
Issuing authority: Plataforma Brasil
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3.582.792
Issuing authority: Comitê de Ética e Pesquisa do hospital Geral Roberto Santos
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15885919.2.0000.5028
Sponsors
- Primary sponsor: Hospital Geral Roberto Santos
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Secondary sponsor:
- Institution: Hospital Geral Roberto Santos
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Supporting source:
- Institution: Hospital Geral Roberto Santos
- Institution: Hospital Geral Roberto Santos
Health conditions
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Health conditions:
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Hospitalization
pt-br
Hospitalização
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General descriptors for health conditions:
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C10.228.140.300.775 Stroke
pt-br
C10.228.140.300.775 Acidente vascular cerebral
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Specific descriptors:
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E02.760.400 Hospitalization
pt-br
E02.760.400 Hospitalização
Interventions
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Interventions:
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Individuals of both sexes, aged between 21 and 75 years, who present a stable clinical condition, with deficit in trunk/balance control and dysphagia and hospitalized for stroke treatment will be included. In the intervention group, 60 individuals will perform functional (functional tests) and respiratory (muscle strength, peak cough flow and chest cirtometry) assessment and after undergoing inspiratory muscle training for 4 weeks with a linear load device and reassessed. In the control group, also with 60 patients, they will undergo conventional motor physical therapy from the hospital, which includes active kinesiotherapy, gait and balance training.
pt-br
Serão incluídos indivíduos de ambos os sexos, com idade entre 21 e 75 anos, que apresentem quadro clínico estável, com déficit de controle de tronco/equilíbrio e disfagia e hospitalizados para tratamento do AVC. No grupo intervenção 60 indivíduos realizarão avaliação funcional (testes funcionais) e respiratória (força muscular, pico de fluxo da tosse e cirtometria torácica) e após submetidos ao treinamento muscular inspiratório por 4 semanas com dispositivo de carga linear e reavaliados. No grupo controle também com 60 pacientes, realizarão fisioterapia motora convencional do hospital, que inclui cinesioterapia ativa, treino de marcha e de equilíbrio.
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Descriptors:
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E02.760.169.063.500.477.500 Stroke Rehabilitation
pt-br
E02.760.169.063.500.477.500 Reabilitação do Acidente Vascular Cerebral
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F02.830.816.541.752 Postural Balance
pt-br
F02.830.816.541.752 Equilibrio Postural
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C05.651.515 Muscle Weakness
pt-br
C05.651.515 Fraqueza muscular
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C06.405.117.119 dysphagia
pt-br
C06.405.117.119 disfagia
Recruitment
- Study status: Recruiting
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Countries
- Brazil
- Date first enrollment: 10/01/2019 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 120 - 18 Y 75 Y -
Inclusion criteria:
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Individuals diagnosed with ischemic or hemorrhagic stroke; of both sexes; aged between 21 and 75 years, who present a stable clinical picture; with trunk control/balance deficit; hospitalized for treatment of the subacute event.
pt-br
Indivíduos com diagnóstico de AVC isquêmico ou hemorrágico; de ambos os sexos; com idade entre 21 e 75 anos, que apresentem quadro clínico estável; com déficit de controle de tronco/equilíbrio; hospitalizados para tratamento do evento subagudo.
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Exclusion criteria:
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incapable of understanding the instructions in the tests, as well as those with aphasics and/or psychiatric disorders that make it impossible to carry out the prescribed exams; those who present oromyofunctional disorders that make it impossible to effectively use the respiratory stimulant; those with a previous history of dysphagia, orotracheal intubation or tracheostomy patients; those who present any pathology with transmission by contact or air, making the use of materials unfeasible; known heart diseases; Untreated SAH and smoking habit. During the post-discharge follow-up, deaths will be excluded; individuals who present a new episode of stroke and other comorbidities that compromise functional performance.
pt-br
Incapazes de compreender as instruções nos testes, bem como os afásicos e/ou com distúrbios psiquiátricos que impossibilitem a realização dos exames previstos; os que apresentarem desordens oromiofuncionais que impossibilitem o efetivo uso do incentivador respiratório; os que tiverem história pregressa de disfagia, intubação orotraqueal ou traqueostomizados; os que apresentarem alguma patologia com transmissão por contato ou via aérea, inviabilizando o uso dos materiais; cardiopatias conhecidas; HAS não tratada e hábito tabagista. Durante o follow-up pós alta serão excluidos os óbitos; os individuos que apresentarem novo episódio de AVE e outras comorbidades que comprometam o desempenho funcional.
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase Other Other 1 N/A N/A N/A
Outcomes
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Primary outcomes:
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Increase in inspiratory muscle strength measured by manovacuometry (80-120) and in peak cough flow measured by pick flow (> 60 lpm), in addition to better performance of thoracic mobility measured by cirtometry.
pt-br
Aumento da força muscular inspiratória medida por manovacuometria (entre 80-120) e do pico de fluxo da tosse medido pelo pick flow (>60 lpm), além da melhor performance da mobilidade torácica medida pela cirtometria.
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Secondary outcomes:
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Improved functionality and social participation measured using the Life-H Scale.
pt-br
Melhora da funcionalidade e participação social medidas por meio da Escala Life-H.
Contacts
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Public contact
- Full name: Caroline Ferreira Guerreiro
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- Address: Rua direta do saboeiro n 10 1 andar
- City: Salvador / Brazil
- Zip code: 40301110
- Phone: +55-071-981099298
- Email: carol.guerreiro@yahoo.com.br
- Affiliation: Hospital Geral Roberto Santos
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Scientific contact
- Full name: Marilucia Reis Santos
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- Address: Rua Suzana de Freitas n 6 1 andar
- City: Salvador / Brazil
- Zip code: 40451390
- Phone: +55-071-988653468
- Email: mari18santos@hotmail.com
- Affiliation: Hospital Geral Roberto Santos
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Site contact
- Full name: Jorge Luis Motta dos Anjos
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- Address: Rua Direta do Saboeiro
- City: Salvador / Brazil
- Zip code: 40301110
- Phone: +55-071-99258326
- Email: jorgelmanjos@hotmail.com
- Affiliation: Hospital Geral Roberto Santos
Additional links:
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