The Effects of Exercise and Probiotics on Dysmenorrhea and Microbiome
NCT ID: NCT05326217
Last Updated: 2022-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2022-01-20
2023-01-19
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
non-dysmenorrhea population with original lifestyle
No interventions assigned to this group
Dysmenorrhea
dysmenorrhea population without exercise intervention
No interventions assigned to this group
Dysmenorrhea+Aerobic Exercise
dysmenorrhea population with aerobic exercise intervention
Aerobic exercise
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).
Dysmenorrhea+Resistant Exercise
dysmenorrhea population with resistant exercise intervention
Resistant exercise
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.
Interventions
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Aerobic exercise
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).
Resistant exercise
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.
Eligibility Criteria
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Inclusion Criteria
* Visual Analog Score of McGill pain questionnaire (0-2 for non-dysmenorrhea; \>5 for dysmenorrhea)
Exclusion Criteria
* Cardiovascular disease, hypertension, diabetes, asthma, chronic pulmonary obstruction, mental illness
18 Years
40 Years
FEMALE
Yes
Sponsors
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National Taipei University of Nursing and Health Sciences
OTHER
Responsible Party
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Wen Ching Huang
Associated professor
Principal Investigators
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Wen Ching Huang, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taipei University of Nursing and Health Sciences
Locations
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National Taipei University of Nursing and Health Sciences
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FJU-IRB-C110039
Identifier Type: -
Identifier Source: org_study_id
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