RBR-3vt4bs Effect of exercise training in inflammatory process control in patients with chronic obstructive pulmonary disease

Date of registration: 11/19/2019 ^(mm/dd/yyyy)
Last approval date : 11/19/2019 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1237-6230

• Public title:

  en

  Effect of exercise training in inflammatory process control in patients with chronic obstructive pulmonary disease

  pt-br

  Efeito do exercício físico no controle do processo inflamatório de pacientes com doença pulmonar obstrutiva crônica

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • CAAE: 04336418.0.0000.0068
    Issuing authority: Plataforma Brasil
  • Número de parecer: 3.118.722
    Issuing authority: Comitê de Ética em Pesquisa do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Sponsors

• Primary sponsor: Hospital das Clínicas da Faculdade de Medicina da USP
• Secondary sponsor:
  • Institution: Faculdade de Medicina da USP
• Supporting source:
  • Institution: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior

Health conditions

• Health conditions:

  en

  Pulmonary Disease, Chronic Obstructive

  pt-br

  Doença Pulmonar Obstrutiva Crônica

• General descriptors for health conditions:

  en

  C08.381.495.389 Pulmonary Disease, Chronic Obstructive

  pt-br

  C08.381.495.389 Doença Pulmonar Obstrutiva Crônica

  es

  C08.381.495.389 Enfermedades respiratorias

• Specific descriptors:

Interventions

• Interventions:

  en

  Experimental group: 25 patients with moderate to severe chronic obstructive pulmonary disease (COPD) will be performed exercise training (aerobic and resisted), 2 times/week, 60 minutes/session for 2 months. Control group: 25 patients with moderate to severe COPD will be performed placebo exercise (respiratory and stretching), 2 times/week, 60 minutes/session for 2 months. The type of exercise was selected at random.

  pt-br

  Grupo experimental: 25 pacientes (homens e mulheres) com doença pulmonar obstrutiva crônica (DPOC) moderada a grave realizarão exercício físico (aeróbios e resistidos), 2 vezes/semana, 60 minutos/sessão por 2 meses. Grupo controle: 25 pacientes (homens e mulheres) com DPOC moderada a grave realizarão exercício placebo (respiratórios e alongamentos), 2 vezes/semana, 60 minutos/sessão por 2 meses. O tipo de exercício foi selecionado de forma aleatorizada.

• Descriptors:

  en

  G11.427.410.698.277 Exercise

  pt-br

  G11.427.410.698.277 Exercício

  es

  G11.427.410.698.277 Ejercicio

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 09/19/2019 ^(mm/dd/yyyy)
• Date last enrollment: 07/30/2021 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  50	-	50 Y	90 Y

• Inclusion criteria:

  en

  Patients with chronic obstructive pulmonary disease; aged over 50 years; non smokers, of both genders; clinically stable; who have not participated in regular physical training in the last 6 months

  pt-br

  Pacientes com doença pulmonar obstrutiva crônica; acima de 50 anos; não fumantes; de ambos os gêneros; clinicamente estáveis; que não tenham participado de treinamento físico regular nos últimos 6 meses

• Exclusion criteria:

  en

  Patients with other chronic lung disease; or with rheumatoid arthritis; multiple sclerosis; decompensated diabetes; autoimmune hepatitis; chronic cardiovascular disease; malignant tumor; or with acquired immunodeficiency syndrome - AIDS; use of immunosuppressive drugs; presence of musculoskeletal disorders that make it impossible to perform physical exercise; continuous use of oxygen therapy

  pt-br

  Pacientes com outra doença pulmonar crônica; com artrite reumatoide; esclerose múltipla; diabetes descompensada; hepatite autoimune; doenças cardiovasculares crônicas; tumor maligno; ou com síndrome da imunodeficiência adquirida - AIDS; uso de medicamentos imunossupressores; presença de doença osteomuscular que impossibilite a realização do exercício físico; uso contínuo de oxigenioterapia

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Double-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Expected to find an increase of 2% of anti-inflammatory cells and cytokines, evaluated in peripheral blood by flow cytometry, in chronic obstructive pulmonary disease patients who will perform the exercise training compared to patients who will perform the placebo exercise.

  pt-br

  Espera-se encontrar um aumento de 2% de células e citocinas anti-inflamatórias, avaliadas no sangue periférico por meio da técnica de citometria de fluxo, em pacientes com doença pulmonar obstrutiva crônica que realizarão o exercício físico comparado aos pacientes que farão o exercício placebo.

• Secondary outcomes:

  en

  It is expected that the increase in anti-inflammatory response is related to the improvement of clinical symptoms and quality of life, assessed through validated questionnaires, of chronic obstructive pulmonary disease patients who will perform the exercise training.

  pt-br

  Espera-se que o aumento da resposta anti-inflamatória esteja relacionada à melhora dos sintomas clínicos e da qualidade de vida, avaliada por meio de questionários validados, dos pacientes com doença pulmonar obstrutiva crônica que realizarão o exercício físico.

Contacts

• Public contact
  • Full name: Fernanda Degobbi Tenorio Quirino dos Santos Lopes
  • • Address: Av. Dr. Arnaldo, 455, Cerqueira César
    • City: São Paulo / Brazil
    • Zip code: 01246-903
  • Phone: +55-011-30617180
  • Email: fernandadtqsl@gmail.com
  • Affiliation: Hospital das Clínicas da Faculdade de Medicina da USP
   
• Scientific contact
  • Full name: Fernanda Degobbi Tenorio Quirino dos Santos Lopes
  • • Address: Av. Dr. Arnaldo, 455, Cerqueira César
    • City: São Paulo / Brazil
    • Zip code: 01246-903
  • Phone: +55-011-30617180
  • Email: fernandadtqsl@gmail.com
  • Affiliation: Hospital das Clínicas da Faculdade de Medicina da USP
   
• Site contact
  • Full name: Fernanda Degobbi Tenorio Quirino dos Santos Lopes
  • • Address: Av. Dr. Arnaldo, 455, Cerqueira César
    • City: São Paulo / Brazil
    • Zip code: 01246-903
  • Phone: +55-011-30617180
  • Email: fernandadtqsl@gmail.com
  • Affiliation: Hospital das Clínicas da Faculdade de Medicina da USP
   

Additional links:

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