RBR-9r5j8g Effects of different respiratory muscle training on functional capacity, respiratory function and quality of life of…

Date of registration: 04/01/2019 ^(mm/dd/yyyy)
Last approval date : 04/01/2019 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1228-6362

• Public title:

  en

  Effects of different respiratory muscle training on functional capacity, respiratory function and quality of life of patients with complete spinal cord injury

  pt-br

  Efeitos de diferentes treinos da musculatura respiratória na capacidade funcional, função respiratória e qualidade de vida de pacientes com lesão medular espinhal motora completa

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 06744919.8.0000.5082
    Issuing authority: Plataforma Brasil
  • 3.146.558
    Issuing authority: Centro de Excelência em ensino, pesquisa e projetos Leide das Neves

Sponsors

• Primary sponsor: Universidade de Brasília
• Secondary sponsor:
  • Institution: Universidade de Brasília
• Supporting source:
  • Institution: Universidade de Brasília

Health conditions

• Health conditions:

  en

  Concussion and oedema of cervical spinal cord

  pt-br

  Concussão e edema da medula cervical

• General descriptors for health conditions:

  en

  C26 Wounds and injuries

  pt-br

  C26 Ferimentos e lesões

  es

  C26 Heridas y lesiones

• Specific descriptors:

Interventions

• Interventions:

  en

  Three groups of patients: Group I: Conventional physiotherapy and inspiratory muscle training with PowerBreathe K5 with high pressure and low flow(22 participants) Group II: Conventional physiotherapy and inspiratory muscle training with PowerBreathe K5 with low pressure and intermediate flow (22 participants) Group III (control): conventional physiotherapy (22 participants)

  pt-br

  Três grupos de pacientes: Grupo I: Fisioterapia convencional e treino muscular inspiratório com PowerBreathe K5 com alta pressão e baixo fluxo (22 participantes) Grupo II: Fisioterapia convencional e treino muscular inspiratório com PowerBreathe K5 com baixa pressão e fluxo intermediário (22 participantes) Grupo III (controle): fisioterapia convencional (22 participantes)

• Descriptors:

  en

  E02.190.525.186 Breathing Exercises

  pt-br

  E02.190.525.186 Exercícios Respiratórios

  es

  E02.190.525.186 Ejercicios Respiratorios

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 03/10/2019 ^(mm/dd/yyyy)
• Date last enrollment: 03/10/2021 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  66	-	18 Y	75 Y

• Inclusion criteria:

  en

  Patients diagnosed with SLE (AIS A or B) according to the American Spinal Injury Association, classified with tetraplegia; At least 6 months of injury; Being in treatment in the hospitalization sector for rehabilitation in the CRER; Both the sexes; Age greater than 18 years; 10% reduction in predicted vital capacity (FVC); Signature of the Informed Consent Term (TCLE).

  pt-br

  Pacientes com diagnóstico de LME (AIS A ou B) de acordo com a American Spinal Injury Association, classificados com tetraplegia; Mínimo de 6 meses de lesão; Estar em tratamento no setor de internação para reabilitação no CRER; Ambos os sexos; Idade superior a 18 anos; Redução da 10% da capacidade vital forçada (CVF) prevista; Assinatura do Termo de Consentimento Livre e Esclarecido (TCLE).

• Exclusion criteria:

  en

  Patients with non-LME associated pulmonary and / or cardiac diseases; Patients with previous neurological disease. Pregnant women.

  pt-br

  Pacientes com doenças pulmonares e/ou cardíacas não associadas a LME; Pacientes com doença neurológica prévia. Mulheres gestantes.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Other	Other	3	Double-blind	Randomized-controlled	0

Outcomes

• Primary outcomes:

  en

  Specific training for muscle strength gain with linear load inspiratory stimuli is expected to be superior to the training of muscle shortening in the variables of endurance and pulmonary endurance, PFT, FVC, and FEV1, as was found in previous studies with cardiopathy patients

  pt-br

  Espera-se que o treino específico para ganho de força muscular com incentivador inspiratório de carga linear possa ser superior ao treino de encurtamento muscular nas variáveis de resistência e endurance pulmonar, PFT, CVF e VEF1, como foi encontrado em estudos prévios com pacientes cardiopatas

• Secondary outcomes:

  en

  It is expected that pulmonary rehabilitation with a linear load resistor associated with conventional physiotherapy may positively influence the functionality, pulmonary resistance and endurance variables, PFT, FVC, and FEV 1 and QV of these patients

  pt-br

  Espera-se que a reabilitação pulmonar com resistor de carga linear associada a fisioterapia convencional possa influenciar positiviamente na funcionalidade, variáveis de resistência e endurance pulmonar, PFT, CVF e VEF1 e QV destes pacientes

Contacts

• Public contact
  • Full name: Letícia de Araújo Morais
  • • Address: RUA 402, N.26, AP.1304, TORRE 3 - PORTAL DO CERRADO
    • City: GOIANIA / Brazil
    • Zip code: 74650-340
  • Phone: +5562992652572
  • Email: leticiadearaujo@hotmail.com
  • Affiliation: Universidade de Brasília
   
• Scientific contact
  • Full name: Letícia de Araújo Morais
  • • Address: RUA 402, N.26, AP.1304, TORRE 3 - PORTAL DO CERRADO
    • City: GOIANIA / Brazil
    • Zip code: 74650-340
  • Phone: +5562992652572
  • Email: leticiadearaujo@hotmail.com
  • Affiliation: Universidade de Brasília
   
• Site contact
  • Full name: Letícia de Araújo Morais
  • • Address: RUA 402, N.26, AP.1304, TORRE 3 - PORTAL DO CERRADO
    • City: GOIANIA / Brazil
    • Zip code: 74650-340
  • Phone: +5562992652572
  • Email: leticiadearaujo@hotmail.com
  • Affiliation: Universidade de Brasília
   

Additional links:

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