The Effects of Exercise and Probiotics on Dysmenorrhea and Microbiome

National Taipei University of Nursing and Health Sciences

Status: Enrolling

Conditions: Microbial Substitution; Inflammation; Dysmenorrhea

Treatments: Other: Aerobic exercise; Other: Resistant exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05326217

FJU-IRB-C110039

Details and patient eligibility

About

The study try to investigate the possible effects of exercise and probiotics supplementation on dysmenorrhea amelioration from the perspective of microbiome.

Full description

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).

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Control Group

No Intervention group

Description:

non-dysmenorrhea population with original lifestyle

Dysmenorrhea

No Intervention group

Description:

dysmenorrhea population without exercise intervention

Dysmenorrhea+Aerobic Exercise

Experimental group

Description:

dysmenorrhea population with aerobic exercise intervention

Treatment:

Other: Aerobic exercise

Dysmenorrhea+Resistant Exercise

Experimental group

Description:

dysmenorrhea population with resistant exercise intervention

Treatment:

Other: Resistant exercise