DysmenorrheaNCT05326217
The Effects of Exercise and Probiotics on Dysmenorrhea and Microbiome
A study testing Aerobic exercise and Resistant exercise in people with Dysmenorrhea and Inflammation, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
The study try to investigate the possible effects of exercise and probiotics supplementation on dysmenorrhea amelioration from the perspective of microbiome. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea, Inflammation, Microbial Substitution
- What is being tested?
- Aerobic exercise and Resistant exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Jan 2022to 19 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primary dysmenorrhea
- Visual Analog Score of McGill pain questionnaire (0-2 for non-dysmenorrhea; >5 for dysmenorrhea)
Who cannot join
- Pregnancy, menstrual disorders, obesity (BMI>30), smoking, and alcohol or drug addiction
- Cardiovascular disease, hypertension, diabetes, asthma, chronic pulmonary obstruction, mental illness
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taipei University of Nursing and Health Sciences
Taipei, 112303
Wen Ching Huang, PhD, +88628227101 ext. 7721, wenching@ntunhs.edu.tw
About this study
Official title: The Effects of Exercise and Probiotics on the Efficacy and Possible Mechanisms of Dysmenorrhea From the Perspective of Microbiome
The study try to investigate the possible effects of exercise and probiotics supplementation on dysmenorrhea amelioration from the perspective of microbiome.
Read the 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
- Dysmenorrhea, Inflammation, Microbial Substitution
- Being tested
- Aerobic exercise, Resistant exercise
- Keywords
- Lactobacillus, Sport nutrition
- Medical subject headings
- Dysmenorrhea, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
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 exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | non-dysmenorrhea population with original lifestyle |
| Dysmenorrhea | No intervention | dysmenorrhea population without exercise intervention |
| Dysmenorrhea+Aerobic Exercise | Experimental | dysmenorrhea population with aerobic exercise intervention Receives: Other: Aerobic exercise |
| Dysmenorrhea+Resistant Exercise | Experimental | dysmenorrhea population with resistant exercise intervention Receives: Other: Resistant exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start20 Jan 2022
- Primary completion19 Jan 2023 (estimated)
- Study completion19 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Ching Huang, National Taipei University of Nursing and Health Sciences
- Investigators
- Wen Ching Huang, PhD, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326217
- Sponsor's protocol ID
- FJU-IRB-C110039
- Status last verified
- Apr 2022
- First submitted
- 29 Mar 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise and Probiotics on the Efficacy and Possible Mechanisms of Dysmenorrhea From the Perspective of Microbiome
- ClinicalTrials.gov ID
- NCT05326217
- Acronym / sponsor ID
- FJU-IRB-C110039
- Conditions
- Dysmenorrhea, Inflammation, Microbial Substitution
- Keywords
- Lactobacillus, Sport nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 19 Jan 2023 (estimated)
- Study completion
- 19 Jan 2023 (estimated)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –non-dysmenorrhea population with original lifestyle |
| Dysmenorrhea | No intervention | –dysmenorrhea population without exercise intervention |
| Dysmenorrhea+Aerobic Exercise | Experimental | Other: Aerobic exercisedysmenorrhea population with aerobic exercise intervention |
| Dysmenorrhea+Resistant Exercise | Experimental | Other: Resistant exercisedysmenorrhea population with resistant exercise intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Primary dysmenorrhea
- Visual Analog Score of McGill pain questionnaire (0-2 for non-dysmenorrhea; >5 for dysmenorrhea)
Key exclusion criteria (2 listed)
- Pregnancy, menstrual disorders, obesity (BMI>30), smoking, and alcohol or drug addiction
- Cardiovascular disease, hypertension, diabetes, asthma, chronic pulmonary obstruction, mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic 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). | Other | Dysmenorrhea+Aerobic Exercise |
| Resistant 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. | Other | Dysmenorrhea+Resistant Exercise |
Primary outcome
The effects of different types of exercise on premenstrual syndrome questionnaire with dysmenorrhea
Time frame: 10 weeks
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.
The effects of different types of exercise on menstrual distress questionnaire with dysmenorrhea
Time frame: 10 weeks
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.
The effects of different types of exercise on McGill pain questionnaire with dysmenorrhea
Time frame: 10 weeks
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.
The effects of different types of exercise on cardiovascular capacity
Time frame: 10 weeks
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.
The effects of different types of exercise on muscular strength of upper limbs
Time frame: 10 weeks
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.
The effects of different types of exercise on power
Time frame: 10 weeks
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.
The effects of different types of exercise on core strength
Time frame: 10 weeks
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.
The effects of different types of exercise on body composition
Time frame: 10 weeks
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.
The microbiome succession of the dysmenorrhea with different types of exercise intervention
Time frame: 10 weeks
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.
The effects of different types of exercise on cytokines in dysmenorrhea
Time frame: 10 weeks
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.
The effects of different types of exercise on biochemistries in dysmenorrhea
Time frame: 10 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Ching Huang, PhD principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Resistant exercise in people with Dysmenorrhea and Inflammation, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen Ching Huang, PhD (+88628227101 ext. 7721, wenching@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of different types of exercise on premenstrual syndrome questionnaire with dysmenorrhea (time frame: 10 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.