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The Effects of Exercise and Probiotics on Dysmenorrhea and Microbiome

Primary Purpose

Dysmenorrhea, Inflammation, Microbial Substitution

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Aerobic exercise
Resistant exercise
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea focused on measuring Lactobacillus, Sport nutrition

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts 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

Sites / Locations

  • National Taipei University of Nursing and Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

No Intervention

Experimental

Experimental

Arm Label

Control Group

Dysmenorrhea

Dysmenorrhea+Aerobic Exercise

Dysmenorrhea+Resistant Exercise

Arm Description

non-dysmenorrhea population with original lifestyle

dysmenorrhea population without exercise intervention

dysmenorrhea population with aerobic exercise intervention

dysmenorrhea population with resistant exercise intervention

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2022
Last Updated
April 6, 2022
Sponsor
National Taipei University of Nursing and Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05326217
Brief Title
The Effects of Exercise and Probiotics on Dysmenorrhea and Microbiome
Official Title
The Effects of Exercise and Probiotics on the Efficacy and Possible Mechanisms of Dysmenorrhea From the Perspective of Microbiome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
January 19, 2023 (Anticipated)
Study Completion Date
January 19, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea, Inflammation, Microbial Substitution
Keywords
Lactobacillus, Sport nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
First stage: Open Label Second stage: Single Blind for probiotics treatment
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
non-dysmenorrhea population with original lifestyle
Arm Title
Dysmenorrhea
Arm Type
No Intervention
Arm Description
dysmenorrhea population without exercise intervention
Arm Title
Dysmenorrhea+Aerobic Exercise
Arm Type
Experimental
Arm Description
dysmenorrhea population with aerobic exercise intervention
Arm Title
Dysmenorrhea+Resistant Exercise
Arm Type
Experimental
Arm Description
dysmenorrhea population with resistant exercise intervention
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Resistant exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
The effects of different types of exercise on premenstrual syndrome questionnaire with dysmenorrhea
Description
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.
Time Frame
10 weeks
Title
The effects of different types of exercise on menstrual distress questionnaire with dysmenorrhea
Description
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.
Time Frame
10 weeks
Title
The effects of different types of exercise on McGill pain questionnaire with dysmenorrhea
Description
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.
Time Frame
10 weeks
Title
The effects of different types of exercise on cardiovascular capacity
Description
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.
Time Frame
10 weeks
Title
The effects of different types of exercise on muscular strength of upper limbs
Description
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.
Time Frame
10 weeks
Title
The effects of different types of exercise on power
Description
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.
Time Frame
10 weeks
Title
The effects of different types of exercise on core strength
Description
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.
Time Frame
10 weeks
Title
The effects of different types of exercise on body composition
Description
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.
Time Frame
10 weeks
Title
The microbiome succession of the dysmenorrhea with different types of exercise intervention
Description
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.
Time Frame
10 weeks
Title
The effects of different types of exercise on cytokines in dysmenorrhea
Description
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.
Time Frame
10 weeks
Title
The effects of different types of exercise on biochemistries in dysmenorrhea
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Ching Huang, PhD
Phone
+88628227101
Ext
7721
Email
wenching@ntunhs.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Ching Huang, PhD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taipei University of Nursing and Health Sciences
City
Taipei
ZIP/Postal Code
112303
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Ching Huang, PhD
Phone
+88628227101
Ext
7721
Email
wenching@ntunhs.edu.tw

12. IPD Sharing Statement

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The Effects of Exercise and Probiotics on Dysmenorrhea and Microbiome

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