RBR-28jpfd Flexibility, Strength, and Balance of Menopausal Women Practicing Exercise

Date of registration: 10/29/2019 ^(mm/dd/yyyy)
Last approval date : 10/29/2019 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1234-1984

• Public title:

  en

  Flexibility, Strength, and Balance of Menopausal Women Practicing Exercise

  pt-br

  Flexibilidade, Força e Equilíbrio das mulheres na Menopausa que Praticam Exercício Físico

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 07485418.4.0000.5515
    Issuing authority: Plataforma Brasil
  • 3.194.590
    Issuing authority: Comitê de ética em pesquisa da universidade do Oeste Paulista

Sponsors

• Primary sponsor: Universidade do Oeste Paulista
• Secondary sponsor:
  • Institution: Universidade do Oeste Paulista
• Supporting source:
  • Institution: Universidade do Oeste Paulista

Health conditions

• Health conditions:

  en

  Disorders of menopause and perimenopause

  pt-br

  Transtornos da menopausa e da perimenopausa

• General descriptors for health conditions:

  en

  M00-M99 XIII - Diseases of the musculoskeletal system and connective tissue

  pt-br

  M00-M99 XIII - Doenças do sistema osteomuscular e do tecido conjuntivo

• Specific descriptors:

Interventions

• Interventions:

  en

  The women in the first moment will be divided, one group submitted to physical exercises in the ground containing 5 participants and another one to exercises in the pool, being this group composed of 14 participants. The longitudinal study will assess flexibility, muscle strength and balance at the beginning of treatment and after 10 sessions will be divided into warm-up, stretching, upper and lower limb strengthening and final relaxation exercises. Blood pressure will be measured before and after exercise. The tests used for each item, respectively, will be: Functional Reach Test, Resisfor, Sit-Up Test, and TUG.

  pt-br

  As mulheres no primeiro momento serão divididas, um grupo submetido a exercícios físicos no solo contendo 5 participantes e outro a exercícios na piscina, sendo este grupo composto por 14 participantes. O estudo longitudinal avaliará flexibilidade, força muscular e equilíbrio no início do tratamento e, após 10 sessões, será dividido em exercícios de aquecimento, alongamento, fortalecimento dos membros superiores e inferiores e relaxamento final. Será aferido apressão arterial antes e após o exercício. Os testes utilizados para cada item, respectivamente, serão: Teste de alance Funcional, Resisfor, Teste de sentar e levantar e TUG.

• Descriptors:

  en

  E01.370.600.425 Muscle strength

  pt-br

  E01.370.600.425 Força muscular

  es

  E01.370.600.425 Otros trastornos menopáusicos y perimenopáusicos

  en

  G11.427.690 Postural Balance

  pt-br

  G11.427.690 Equilíbrio Postural

  es

  G11.427.690 Balance Postural

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 03/29/2019 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  19	F	45 -	65 Y

• Inclusion criteria:

  en

  Inclusion criteria are all female participants in menopausal climacteric period between the ages of 45 and 65, who are able to perform exercises that were hemodynamically stable and participants in the extension project.

  pt-br

  Os critérios de inclusão são: todas as participantes mulheres estando no climatério e período menopausal na faixa etária entre 45 e 65 anos; que consigam realizar os exercícios; que estavam hemodinamicamente estáveis e participantes do projeto de extensão.

• Exclusion criteria:

  en

  Women who had a severe chronic disease with a blood glucose lower than 70 mg / dl or higher than 250 mg / dl and a blood pressure greater than or equal to 120 mmhg were excluded and who were unable to perform the proposed tests.

  pt-br

  Foram excluídas as mulheres que possuíam alguma doença crônica grave; com a glicemia inferior a 70 mg/dl ou superior a 250 mg/dl e pressão arterial superior ou igual 120 mmhg e que eram incapazes de realizar os testes propostos.

Study type

• Study design:

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

Outcomes

• Primary outcomes:

  en

  Muscle strength was measured in seconds by resisfor test for upper limbs, sitting and lifting for lower limbs.

  pt-br

  Força muscular foi medido em segundos através do teste resisfor para membros supeiores, sentar e levantar para membro inferiores.

• Secondary outcomes:

  en

  Flexibility was measured by centimeters using the Functional Range test, Balance assessed in seconds using the Tug (time up and go) test.

  pt-br

  Flexibilidade foi medida por centímetros através do teste de Alcance Funcional, Equilíbrio avaliado em segundos através do teste Tug (time up and go)

Contacts

• Public contact
  • Full name: Suellen Silvestre Gonzaga
  • • Address: Ademar Alves da Silva, Vila Soler
    • City: Pirapozinho / Brazil
    • Zip code: 19200-000
  • Phone: +55 (18) 981313341
  • Email: suhsg06@hotmail.com
  • Affiliation: Universidade do Oeste Paulista
   
• Scientific contact
  • Full name: Suellen Silvestre Gonzaga
  • • Address: Ademar Alves da Silva, Vila Soler
    • City: Pirapozinho / Brazil
    • Zip code: 19200-000
  • Phone: +55 (18) 981313341
  • Email: suhsg06@hotmail.com
  • Affiliation: Universidade do Oeste Paulista
   
• Site contact
  • Full name: Suellen Silvestre Gonzaga
  • • Address: Ademar Alves da Silva, Vila Soler
    • City: Pirapozinho / Brazil
    • Zip code: 19200-000
  • Phone: +55 (18) 981313341
  • Email: suhsg06@hotmail.com
  • Affiliation: Universidade do Oeste Paulista
   

Additional links:

• Download in ICTRP format