The Effects of Exercise and Probiotics on Dysmenorrhea and Microbiome
6 de abril de 2022 atualizado por: Wen Ching Huang, National Taipei University of Nursing and Health Sciences
The Effects of Exercise and Probiotics on the Efficacy and Possible Mechanisms of Dysmenorrhea From the Perspective of Microbiome
The study try to investigate the possible effects of exercise and probiotics supplementation on dysmenorrhea amelioration from the perspective of microbiome.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
In current study, there were two stages designed for current study. The definition of dysmenorrhea population depended on the Visual Analogue Scale (VAS) of McGill Pain Questionnaire (more than 5) and the VAS score less than 2 was considered as non-dysmenorrhea population.
In the first stage, the 20 subjects were recruit for non-dysmenorrhea group (Control group) and other 60 subjects were randomly allocated into three group with original lifestyle, aerobic, and resistant exercise intervention (Dys-Control, Dys-Aerobic, and Dys-resistant groups). The questionnaires (Premenstrual syndrome, the Menstrual Distress, and McGill Pain), body composition, physical fitness, biochemistries, inflammation, hormones and microbiome analysis (feces and tampon) were evaluated and assessed before and after 10-weeks indicated exercise training.
In the second stage, one hundred subjects (20 non-dysmenorrhea and 80 dysmenorrhea populations) will be recruited and the dysmenorrhea will be randomly allocated into Dys-Control, Dys-probiotics, Dys-exercise and Dys-probiotics and exercise groups. The questionnaires (Premenstrual syndrome, the Menstrual Distress, and McGill Pain), body composition, physical fitness, biochemistries, inflammation, hormones and microbiome analysis (feces and tampon) were evaluated and assessed before and after 10-weeks indicated interventions (probiotics and exercise).
Tipo de estudo
Intervencional
Inscrição (Antecipado)
80
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Wen Ching Huang, PhD
- Número de telefone: 7721 +88628227101
- E-mail: wenching@ntunhs.edu.tw
Locais de estudo
-
-
-
Taipei, Taiwan, 112303
- Recrutamento
- National Taipei University of Nursing and Health Sciences
-
Contato:
- Wen Ching Huang, PhD
- Número de telefone: 7721 +88628227101
- E-mail: wenching@ntunhs.edu.tw
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 40 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- Primary dysmenorrhea
- Visual Analog Score of McGill pain questionnaire (0-2 for non-dysmenorrhea; >5 for dysmenorrhea)
Exclusion Criteria:
- Pregnancy, menstrual disorders, obesity (BMI>30), smoking, and alcohol or drug addiction
- Cardiovascular disease, hypertension, diabetes, asthma, chronic pulmonary obstruction, mental illness
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Control Group
non-dysmenorrhea population with original lifestyle
|
|
|
Sem intervenção: Dysmenorrhea
dysmenorrhea population without exercise intervention
|
|
|
Experimental: Dysmenorrhea+Aerobic Exercise
dysmenorrhea population with aerobic exercise intervention
|
The aerobic exercise :In this study, the exercise intensity is set based on the subject's maximum heart rate, and the target heart rate is adjusted according to the literature to reach 60-90% of the maximum heart rate.
A gradual increase of intermittent exercise will be designed for current exercise prescription.
In terms of exercise frequency and time, there will be two times interventions per week for at least 60 minutes per time (including warm-up and cool down exercises).
|
|
Experimental: Dysmenorrhea+Resistant Exercise
dysmenorrhea population with resistant exercise intervention
|
The resistant exercise : muscular endurance (15-20RM) and muscular hypertrophy (8-12RM) are applied to main exercise intensity.
The intensity is gradually adjusted according to the state of each subject, and the intervention is performed twice a week (50 minutes per time).The target muscles of resistance training include quadriceps femoris, biceps femoris, calf muscles, core muscles (including pelvic floor muscles), back muscles, pectoralis major, biceps/triceps and other muscle groups.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The effects of different types of exercise on premenstrual syndrome questionnaire with dysmenorrhea
Prazo: 10 weeks
|
The premenstrual syndrome questionnaire is applied for evaluation of premenstrual syndromes before mense.
A higher score indicates severer indicated syndromes.
Changes of the premenstrual syndrome questionnaire measure will be assessed at the 0 week and 10 weeks.
|
10 weeks
|
|
The effects of different types of exercise on menstrual distress questionnaire with dysmenorrhea
Prazo: 10 weeks
|
The menstrual distress questionnaire is applied for evaluation of distress syndromes during mense.
A higher score indicates severer indicated syndromes.
Changes of the menstrual distress questionnaire measure will be assessed at the 0 week and 10 weeks.
|
10 weeks
|
|
The effects of different types of exercise on McGill pain questionnaire with dysmenorrhea
Prazo: 10 weeks
|
The McGill pain questionnaire is applied for evaluation of types and degrees of pain during mense.
A higher score indicates severer indicated syndromes.
Changes of theMcGill pain questionnaire measure will be assessed at the 0 week and 10 weeks.
|
10 weeks
|
|
The effects of different types of exercise on cardiovascular capacity
Prazo: 10 weeks
|
The cardiovascular capacity is evaluated by 3-minute step test.
The higher index of cardiovascular capacity means the higher cardiovascular fitness.
Changes of cardiovascular capacity will be assessed at the 0 week, and 10 weeks.
|
10 weeks
|
|
The effects of different types of exercise on muscular strength of upper limbs
Prazo: 10 weeks
|
The muscular strength of upper limbs is evaluated by grip-strength test.
The higher strength of test means the higher strength fitness in upper limbs.
Changes of muscular strength of upper limbs will be assessed at the 0 week, and 10 weeks.
|
10 weeks
|
|
The effects of different types of exercise on power
Prazo: 10 weeks
|
The power is evaluated by standing long jump.
The higher distance of test means the higher power fitness.
Changes of power will be assessed at the 0 week, and 10 weeks.
|
10 weeks
|
|
The effects of different types of exercise on core strength
Prazo: 10 weeks
|
The core strength endurance is evaluated by 1-minute bent-knee sit-up test.
The higher repetitions mean the higher core strength endurance fitness.
Changes of core strength endurance will be assessed at the 0 week, and 10 weeks.
|
10 weeks
|
|
The effects of different types of exercise on body composition
Prazo: 10 weeks
|
The body composition was simultaneously measured by Inbody 270 (Bioelectrical Impedance Analysis) for outcome measures including body-fat percentage, and muscular percentage in the upper and lower limbs.
The higher muscular percentage and lower body-fat percentage are associated with better fitness.
Changes of body-fat percentage, and muscular percentage in the upper and lower limbs measures will be assessed at the 0 week, and 10 weeks.
|
10 weeks
|
|
The microbiome succession of the dysmenorrhea with different types of exercise intervention
Prazo: 10 weeks
|
Determination of the gut microbiota composition from the feces and tampon samples by 16S metagenomic, data analysis and building of a mathematical model to test the potential modulation of the gut microbiota architecture for primary dysmenorrhea.Changes of microbiota succession in the feces and tampons will be assessed at the 0 week, and 10 weeks.
|
10 weeks
|
|
The effects of different types of exercise on cytokines in dysmenorrhea
Prazo: 10 weeks
|
The cytokines was simultaneously measured by enzyme-linked immunosorbent assay for outcome measures including TNF-α, IL-1β, IL-6, and IL-10.
The higher TNF-α, IL-1β, and IL-6 cytokines mean the higher inflammation and higher IL-10 mean the higher immunosuppression.
Changes of cytokines measures will be assessed at the 0 week, and 10 weeks.
|
10 weeks
|
|
The effects of different types of exercise on biochemistries in dysmenorrhea
Prazo: 10 weeks
|
The biochemical variables were simultaneously measured by automated clinical chemistry analyzer for outcome measures including VEGF, Estrogen, Progesterone, adrenaline, cortisol, serotonin, PEG2, PGF2α, Prostacyclin, and Thromboxane.
The expressive levels of indicated indexes mean different physiological modulations.
Changes of biochemical measures will be assessed at the 0 week, and 10 weeks.
|
10 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Investigadores
- Investigador principal: Wen Ching Huang, PhD, National Taipei University of Nursing and Health Sciences
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
20 de janeiro de 2022
Conclusão Primária (Antecipado)
19 de janeiro de 2023
Conclusão do estudo (Antecipado)
19 de janeiro de 2023
Datas de inscrição no estudo
Enviado pela primeira vez
29 de março de 2022
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de abril de 2022
Primeira postagem (Real)
13 de abril de 2022
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de abril de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de abril de 2022
Última verificação
1 de abril de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- FJU-IRB-C110039
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .