Clinical Trials Directory

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UnknownNCT05326217

The Effects of Exercise and Probiotics on Dysmenorrhea and Microbiome

The Effects of Exercise and Probiotics on the Efficacy and Possible Mechanisms of Dysmenorrhea From the Perspective of Microbiome

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
National Taipei University of Nursing and Health Sciences · Academic / Other
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Accepted

Summary

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

Detailed 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).

Conditions

Interventions

TypeNameDescription
OTHERAerobic exerciseThe 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).
OTHERResistant exerciseThe 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.

Timeline

Start date
2022-01-20
Primary completion
2023-01-19
Completion
2023-01-19
First posted
2022-04-13
Last updated
2022-04-13

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT05326217. Inclusion in this directory is not an endorsement.