Effects of Inspiratory Muscle Training on the Functional Gait Performance of Individuals After Stroke
The most commonly observed sequel after stroke is muscle weakness, which can also be identified in respiratory muscles, in the acute and chronic phases, and may compromise the lung function of these individuals. Studies have shown that lower Pimax values are found in non-community ambulators, and gait velocity has been reported as an important indicator of functionality after stroke, with higher gait velocity values associated with greater community participation and better quality of life.
This study will test the hypothesis that training of the inspiratory muscles is effective in improving strength and endurance of the inspiratory muscles and functionality, including speed of gait, functional gait perfomarnce, activities of daily living and quality of life with stroke subjects.
For this clinical trial, people after stroke will be randomly allocated into either experimental or control/sham groups. The experimental group will undertake training of the inspiratory muscles with the Power Breath Medical Classic device regulated at 50% of the subjects' maximal inspiratory pressure values, five times/week over six weeks, twice a day for 15 minutes, totaling 30 minutes/day. The control group will undertake the same protocol, but the participants will receive the devices with a minimal load, wich corresponds to 1cmH2O. Both groups will participate in the rehabilitation program for 6 weeks. At baseline and post intervention, after the cessation of the interventions, researchers blinded to group allocations will collect the following outcome measures: maximal respiratory pressures, respiratory muscle endurance, functional gait performance, activities of daily living and quality of life. After 12 weeks will collect again maximal inspiratory pressures and functional gait performance.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
The most commonly observed sequel after stroke is muscle weakness, which can also be identified in respiratory muscles, in the acute and chronic phases, and may compromise the lung function of these individuals. Studies have shown that lower Pimax values are found in non-community ambulators, and gait velocity has been reported as an important indicator of functionality after stroke, with higher gait velocity values associated with greater community participation and better Quality of life.
Aim: This study will test the hypothesis that training of the inspiratory muscles is effective in improving strength and endurance of the inspiratory muscles and functional gait perfomarnce, activities of daily living and quality of life with stroke subjects.
Design: For this prospective, triple-blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control/sham groups. The experimental group will undertake training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 50% of the subjects' maximal inspiratory pressure (MIP) values, five times/week over six weeks during 30 minutes/day. The control group will undertake the same protocol, but the participants will receive the threshold devices with minimal resistance valves. At baseline and post intervention after the cessation of the interventions, researchers blinded to group allocations will collect all outcome measures. After 12 weeks will collect again maximal inspiratory pressures and functional gait performance.
Study outcomes: Primary outcomes will be functional gait perfomarnce. Secondary outcomes will include inspiratory endurance, activities of daily living and quality of life.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
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Bahia
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Salvador, Bahia, Brasil
- Lorena de Oliveira Vaz Miranda
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Adults with hemiparesis after stroke, of any etiology, ischemic or hemorrhagic, that carry out walking with or without assistance locomotion; Aged between 18 and 80 years of age; In the chronic period (between 6 months and 5 years); clinically stable (Measured through clinical and hemodynamic stability: vital signs within normal and released for physical activity by the physician), who present with inspiratory muscle weakness, defined as Pimáx less than -80cmH2O and score in the normal Mini Mental State Examination (MMSE) For schooling.
Exclusion Criteria:
- Smokers and ex-smokers for more than five years, presence of facial paralysis that prevents lip occlusion, associated neurological diseases, orthopedic alterations that include distortions of the chest cavity or pains that prevent the tests from being performed, respiratory dysfunctions, cardiac dysfunctions that Compromise hemodynamic stability.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Grupo experimental
|
Experimental: IMT will include training of the inspiratory muscles five times per week over six weeks, divided into two fiftten-minute sessions of inspiratory training totaling 30 minutes of training. Thresholds regulated at 50% of the subjects' maximal inspiratory pressure values, the load being increased weekly. Associated with the IMT, subjects will participate in the rehabilitation program, when they will perform 7 sessions of physiotherapy per week, totaling 42 sessions, as well as 180 minutes per week of aerobic exercise, for six weeks. Sham Group: This group will underwent exactly the same protocol but the participants will receive the threshold devices with the minimum resistance of the spring, which will be also concealed. The control group will also participate in the rehabilitation program and undergo the same procedures, except for the load adjustments. |
|
Comparador Falso: Grupo de controle
|
Experimental: IMT will include training of the inspiratory muscles five times per week over six weeks, divided into two fiftten-minute sessions of inspiratory training totaling 30 minutes of training. Thresholds regulated at 50% of the subjects' maximal inspiratory pressure values, the load being increased weekly. Associated with the IMT, subjects will participate in the rehabilitation program, when they will perform 7 sessions of physiotherapy per week, totaling 42 sessions, as well as 180 minutes per week of aerobic exercise, for six weeks. Sham Group: This group will underwent exactly the same protocol but the participants will receive the threshold devices with the minimum resistance of the spring, which will be also concealed. The control group will also participate in the rehabilitation program and undergo the same procedures, except for the load adjustments. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
change in functional gait perfomarnce
Prazo: change from Baseline at 6 weeks
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functional gait perfomarnce will be assessed by six minute walk test.
(6MWT)
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change from Baseline at 6 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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endurance muscular respiratory
Prazo: Baseline and after 6 weeks
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inspiratory and expiratory endurance will be assessed by the threshold devices, following previously described protocols.
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Baseline and after 6 weeks
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maximal respiratory pressures
Prazo: Baseline, after 6 six weeks and three-monsth follow-ups
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Maximal respiratory pressures will be assessed by a analogic manovacuometer, following previously described protocols.
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Baseline, after 6 six weeks and three-monsth follow-ups
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functional gait perfomarnce
Prazo: three-monsth follow-ups
|
functional gait perfomarnce will be assessed by six minute walk test.
(6MWT)
|
three-monsth follow-ups
|
|
activities of daily living
Prazo: Baseline and after 6 weeks
|
activities of daily living: will be assessed by measure independence functional (MIF)
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Baseline and after 6 weeks
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Quality of life
Prazo: Baseline, after 6 weeks and three-monsth follow-ups
|
Quality of life will be assessed by the Brazilian version of the EQ5D.
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Baseline, after 6 weeks and three-monsth follow-ups
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Jamary Oliveira Filho, Federal University of Bahia
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 65028517.0.0000.0022
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Descrição do plano IPD
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