The Effects of Exercise and Probiotics on Dysmenorrhea and Microbiome

N

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)

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

Trial contacts and locations

1

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Central trial contact

Gian Andrea Rollandi, MD

Data sourced from clinicaltrials.gov

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