The Effects of Exercise and Probiotics on Dysmenorrhea and Microbiome
1 other identifier
interventional
80
1 country
1
Brief Summary
The study try to investigate the possible effects of exercise and probiotics supplementation on dysmenorrhea amelioration from the perspective of microbiome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2022
CompletedFirst Submitted
Initial submission to the registry
March 29, 2022
CompletedFirst Posted
Study publicly available on registry
April 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2023
CompletedApril 13, 2022
April 1, 2022
12 months
March 29, 2022
April 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
The effects of different types of exercise on premenstrual syndrome questionnaire with dysmenorrhea
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
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
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
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
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
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
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
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
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
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
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
Study Arms (4)
Control Group
NO INTERVENTIONnon-dysmenorrhea population with original lifestyle
Dysmenorrhea
NO INTERVENTIONdysmenorrhea population without exercise intervention
Dysmenorrhea+Aerobic Exercise
EXPERIMENTALdysmenorrhea population with aerobic exercise intervention
Dysmenorrhea+Resistant Exercise
EXPERIMENTALdysmenorrhea population with resistant exercise intervention
Interventions
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).
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
You may qualify if:
- Primary dysmenorrhea
- Visual Analog Score of McGill pain questionnaire (0-2 for non-dysmenorrhea; \>5 for dysmenorrhea)
You may not qualify if:
- Pregnancy, menstrual disorders, obesity (BMI\>30), smoking, and alcohol or drug addiction
- Cardiovascular disease, hypertension, diabetes, asthma, chronic pulmonary obstruction, mental illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taipei University of Nursing and Health Sciences
Taipei, 112303, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wen Ching Huang, PhD
National Taipei University of Nursing and Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- First stage: Open Label Second stage: Single Blind for probiotics treatment
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated professor
Study Record Dates
First Submitted
March 29, 2022
First Posted
April 13, 2022
Study Start
January 20, 2022
Primary Completion
January 19, 2023
Study Completion
January 19, 2023
Last Updated
April 13, 2022
Record last verified: 2022-04