RBR-4cj96jy The benefits of Physical Training for the autonomic nervous system and cognition in women who are Breast Cancer survivor...

Date of registration: 08/20/2024 ^(mm/dd/yyyy)
Last approval date : 08/20/2024 ^(mm/dd/yyyy)

Study type:

Observational

Scientific title:

Trial identification

• UTN code: U1111-1302-8334

• Public title:

  en

  The benefits of Physical Training for the autonomic nervous system and cognition in women who are Breast Cancer survivors

  pt-br

  Os benefícios do Treinamento Físico para o sistema nervoso autonômico e para a cognição de mulheres sobreviventes de Câncer de Mama

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 59127522.3.0000.5391
    Issuing authority: Plataforma Brasil
  • 6.072.780
    Issuing authority: Comitê de Ética da Escola de Educação Física e Esporte da Universidade de São Paulo
  • 3045/22
    Issuing authority: Comitê de Ética em Pesquisa da Comissão Científica de Ensino e Pesquisa do Instituto do Câncer do Estado de São Paulo

Sponsors

• Primary sponsor: Universidade de São Paulo
• Secondary sponsor:
  • Institution: Instituto do Câncer do Estado de São Paulo
• Supporting source:
  • Institution: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior

Health conditions

• Health conditions:

  en

  Autonomic Nervous System disorders; Other symptoms and signs relating to cognitive function and consciousness

  pt-br

  Transtornos do Sistema Nervoso Autônomo; Outros sintomas e sinais relativos à função cognitiva e à consciência

• General descriptors for health conditions:

  en

  C50 Malignant breast neoplasm

  pt-br

  C50 Neoplasia maligna da mama

• Specific descriptors:

  en

  G90 Autonomic Nervous System disorders

  pt-br

  G90 Transtornos do Sistema Nervoso Autônomo

  en

  R41 Other symptoms and signs relating to cognitive function and consciousness

  pt-br

  R41 Outros sintomas e sinais relativos à função cognitiva e à consciência

Interventions

• Interventions:

  en

  This was a single-center, cross-sectional, observational study with a convenience sample, consisting of three groups of 30 women in each group, aged between 37 and 75 years. Experimental group 1: 30 female breast cancer survivors who had been exercising for at least 6 months. Experimental group 2: 30 female breast cancer survivors who had not exercised in the last 6 months. Control group: 30 healthy women matched by age who had not exercised in the last 6 months. All groups undergo the same protocol: autonomic nervous system analysis tests (Ewing tests), physical functionality tests (Hand Grip, Displacement with and without dual task, Arm flexion, Sit-to-stand test, 2-min stationary gait test), cardiorespiratory tests (adaptation of the Balk protocol), cognitive tests (Moca tests, Trail Making Test A and B, Ravlt memory test, Digit Symbol Substitution Test, Five-Digit Test), accelerometry analysis, application of questionnaires (sociodemographic, physical activity questionnaire-ipaq, qlq30, dass21). For randomization of the experimental groups, access is available to the Electronic Medical Record, Tasy, of the Cancer Institute of the State of São Paulo of the Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo. Contact with potential volunteers will be by telephone call made at the facilities of the same Institute. The randomization of the control group is done through dissemination on social media and dissemination channels of the institutions involved in the study, with contacts, with potential volunteers, via email and telephone calls

  pt-br

  Trata-se de um estudo observacional transversal, unicêntrico, com amostra de conveniência, composto por três grupos de 30 mulheres em cada grupo, com idade entre 37 e 75 anos. Grupo experimental 1: 30 mulheres sobreviventes de câncer de mama, praticantes de exercício físico há pelo menos 6 meses. Grupo experimental 2: 30 mulheres sobreviventes de câncer de mama, que não praticaram exercícios físicos nos últimos 6 meses. Grupo controle: 30 mulheres saudáveis pareadas pela idade que não praticaram exercícios físicos nos últimos 6 meses. Todos os grupos passam pelo mesmo protocolo: testes de análise do sistema nervoso autonômico (Testes de Ewing), testes de funcionalidade física (Hand Grip, Deslocamento com e sem dupla tarefa, Flexão de braço, Teste de sentar e levantar, Teste de marcha estacionária 2min), testes cardiorrespiratório (adaptação protocolo de Balk), testes cognitivos (Testes de Moca, Teste de Trilha A e B, Teste de memória Ravlt, Digit Symbol Substitution Test, Teste de Cinco Dígitos), análise de acelerometria, aplicação de questionários (sociodemográfico, questionário internacional de atividade física-ipaq, qlq30, dass21). Para a randomização dos grupos experimentais conta-se com o acesso ao Prontuário Eletrônico, Tasy, do Instituto do Câncer do Estado de São Paulo do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo. O contato com as possíveis voluntárias será através de chamada telefônica realizada nas dependências do mesmo Instituto. A aleatorização do grupo controle é através de divulgação em mídias sociais e canais de divulgação das instituições envolvidas no estudo, com contatos, com as possíveis voluntárias, via e-mail e chamadas telefônicas

• Descriptors:

  en

  F04.711.513 Neuropsychological Tests

  pt-br

  F04.711.513 Testes Neuropsicológicos

  en

  C10.177 Autonomic Nervous System Diseases

  pt-br

  C10.177 Doenças do Sistema Nervoso Autônomo

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 06/05/2023 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  90	F	35 Y	75 Y

• Inclusion criteria:

  en

  Group 1 women; aged between 35 and 75 years; survivors of histologically proven invasive breast cancer; who completed treatment with curative intent including systemic chemotherapy; having completed treatment within a time interval of at least six months to four years; practicing physical exercises for at least 6 months as defined by the application of the international physical activity questionnaire (IPAQ); Group 2 women; aged between 35 and 75 years; survivors of histologically proven invasive breast cancer; who completed treatment with curative intent including systemic chemotherapy following the recommended guidelines; having completed treatment within a time interval of at least six months to four years; without regular practice of physical exercises in the last 6 months as defined by the application of the International international physical activity questionnaire (IPAQ); Group 3 women; aged 35-75 years; without a diagnosis of cancer; non-practitioners of systematic physical exercise on a regular basis in the last 6 months as defined by the application of the international physical activity questionnaire (IPAQ)

  pt-br

  Grupo 1 mulheres; com idade entre 35 e 75 anos; sobreviventes de câncer de mama invasivo comprovado histologicamente; que concluíram o tratamento com intenção curativa incluindo quimioterapia sistêmica; tendo concluído o tratamento dentro de um intervalo de tempo de pelo menos seis meses até quatro anos; praticantes de exercícios físicos por pelo menos 6 meses conforme definido pela aplicação do questionário internacional de atividade física (IPAQ); Grupo 2 mulheres; com idade entre 35 e 75 anos; sobreviventes de câncer de mama invasivo comprovado histologicamente; que concluíram o tratamento com intenção curativa incluindo quimioterapia sistêmica seguindo as diretrizes recomendadas; tendo concluído o tratamento dentro de um intervalo de tempo de pelo menos seis meses até quatro anos; sem prática regular de exercícios físicos nos últimos 6 meses conforme definido pela aplicação do questionário internacional de atividade física (IPAQ); Grupo 3 mulheres; com 35-75 anos de idade; sem diagnóstico de câncer; não praticantes de exercícios físicos sistematizados de maneira regular nos últimos 6 meses conforme definido pela aplicação do questionário internacional de atividade física (IPAQ)

• Exclusion criteria:

  en

  Group 1: evidence of metastatic disease (clinical and/or radiological) and/or conditions that prevent them from practicing physical exercise; severe organic dysfunctions (including, but not limited to, kidney failure, heart failure and chronic liver disease); previous cognitive dysfunction and (or) dysautonomia; presence of any medical contraindication to physical exercise; not being involved in any systematic exercise practice on a regular basis in the last 6 months.Group 2: evidence of metastatic disease (clinical and/or radiological) and/or conditions that prevent them from practicing physical exercise; severe organic dysfunctions (including, but not limited to, kidney failure, heart failure and chronic liver disease); previous cognitive dysfunction and (or) dysautonomia; presence of any medical contraindication to physical exercise; being involved in some systematic exercise practice on a regular basis in the last 6 months. Group 3: history of cancer treatment; presence of autonomic dysfunctions, cardiovascular problems, diagnosis of neurological diseases with cognitive involvement and presence of conditions that prevent them from practicing physical exercise; report of practicing systematic physical exercises, regularly, in the last 6 months

  pt-br

  Group 1: women under 35 and over 75 years of age with evidence of metastatic disease (clinical and/or radiological) and/or conditions that prevent them from practicing physical exercise; severe organic dysfunctions (including but not limited to renal failure, heart failure and chronic liver disease); previous cognitive dysfunction and/or dysautonomia; presence of any medical contraindication to the practice of physical exercise; not having been involved in any physical exercise practice on a regular basis in the last 6 months. Group 2: women under 35 and over 75 years of age with evidence of metastatic disease (clinical and/or radiological) and/or conditions that prevent them from practicing physical exercise; severe organic dysfunctions (including but not limited to renal failure, heart failure and chronic liver disease); previous cognitive dysfunction and/or dysautonomia; presence of any medical contraindication to the practice of physical exercise; having been involved in any physical exercise practice on a regular basis in the last 6 months. Group 3: women under 35 and over 75 years of age with a history of cancer treatment; presence of autonomic dysfunctions; cardiovascular problems; diagnosis of neurological diseases with cognitive involvement and presence of conditions that prevent them from practicing physical exercise; report of practicing physical exercise in the last 6 months

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase

Outcomes

• Primary outcomes:

  en

  To evaluate, using the battery of Ewing autonomic tests and the analysis of heart rate variability, whether women survivors of breast cancer, who have experienced classic antineoplastic treatment, with chemotherapy, present autonomic changes resulting from the toxicity of this treatment

  pt-br

  Avaliar por meio da bateria de testes autonômicos de Ewing e da análise da variabilidade da frequência cardíaca se mulheres sobreviventes de câncer de mama, que experimentaram o tratamento antineoplásico clássico, com consumo de quimioterapia, apresentam alterações de natureza autonômicas decorrentes da toxicidade desse tratamento

• Secondary outcomes:

  en

  By carrying out cognitive tests and autonomic analysis tests, it is expected to find a possible association between autonomic changes and perceived cognitive impairment in women who are breast cancer survivors

  pt-br

  Através da realização de testes cognitivos e testes de análise autonômica, espera-se encontrar uma possível associação entre alterações autonômicas ao comprometimento cognitivo percebido em mulheres sobreviventes de câncer de mama

  en

  Through tests of physical functionality, physical fitness level and the IPAQ questionnaire, the aim is to evaluate whether women survivors of breast cancer who have undergone chemotherapy treatment and who have more active lifestyle patterns, can present better autonomic balance scores and preservation of cognitive variables

  pt-br

  Através de testes de funcionalidade física, acelerometria, teste ergoespirométrico e do questionário IPAQ, iremos observar se mulheres sobreviventes de câncer de mama que fizeram tratamento com quimioterapia e que apresentam padrões de vida mais ativo, apresentam melhores escores de balanço autonômico e de preservação de variáveis cognitivas

  en

  We will observe, through the application of the QLQ30 and DASS21 questionnaires, whether female breast cancer survivors who have undergone chemotherapy and are physically active have better quality of life scores, when compared to female breast cancer survivors who have experienced the same treatment and are not exercisers

  pt-br

  Iremos observar, através da aplicação dos questionários QLQ30 e DASS21, se mulheres sobreviventes de câncer de mama que passaram pela quimioterapia e são fisicamente ativas apresentam melhores escores de qualidade de vida, quando comparadas a mulheres sobreviventes de câncer de mama que experimentaram o mesmo tratamento e não são exercitadoras

Contacts

• Public contact
  • Full name: Patricia Chakur Brum
  • • Address: Prof. Mello Moraes, 65 Cidade Universitária
    • City: São Paulo / Brazil
    • Zip code: 05508-030
  • Phone: +55(11)30913095
  • Email: pcbrum@usp.br
  • Affiliation: Universidade de São Paulo
   
• Scientific contact
  • Full name: Patricia Chakur Brum
  • • Address: Prof. Mello Moraes, 65 Cidade Universitária
    • City: São Paulo / Brazil
    • Zip code: 05508-030
  • Phone: +55(11)30913095
  • Email: pcbrum@usp.br
  • Affiliation: Universidade de São Paulo
   
• Site contact
  • Full name: Patricia Chakur Brum
  • • Address: Prof. Mello Moraes, 65 Cidade Universitária
    • City: São Paulo / Brazil
    • Zip code: 05508-030
  • Phone: +55(11)30913095
  • Email: pcbrum@usp.br
  • Affiliation: Universidade de São Paulo
   

Additional links:

• Download in ICTRP format