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Examination of Menstruation Symptoms in Women Who Exercise Regularly.

Primary Purpose

Menstrual Problem

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
control
exercise
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menstrual Problem focused on measuring sleep, menstruation, stress

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Women between the ages of 18-50 whose menstrual cycle continues, Those who have emotional or physical problems during menstruation periods, Those whose menstrual cycle is between 21-40 days on average Exclusion Criteria: Those with chronic disease Those with a diagnosed gynecological disease, Those who receive any medical treatment, Persons with dysmenorrhea and anemia. People who exercise regularly.

Sites / Locations

  • Üsküdar UnıversıtyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

exercise group

Arm Description

no exercise will be given

exercise training will be given and they will be asked to exercise regularly.

Outcomes

Primary Outcome Measures

Pittsburgh Sleep Quality Scale
The pittsburgh Sleep Quality Index is a quantitative measure of sleep quality to define good and bad sleep. It includes 24 questions in total. The self-assessment questions include various items related to sleep quality. The total score is between 0-21. A high total score indicates poor sleep quality. The index does not indicate the presence of sleep disturbances or the prevalence of sleep disturbances. However, a pittsburgh Sleep Quality Index total score of five or more indicates poor sleep quality.
Fatigue Severity Scale
It consists of 9 questions. Each question is scored between 1 and 7. Statements Regarding Scoring 1. I strongly disagree 3. I tend to disagree 5. I tend to agree 2. I disagree 4. I am undecided 6. I agree 7. I strongly agree. ) the score of the answers given to the question is added and divided by 9. If the result is less than 2.8, it is evaluated as "no fatigue". If the result is greater than 6.1, it is considered as "chronic fatigue syndrome".
Short form of the International Physical Activity Questionnaire
provides information on time spent walking, moderate and vigorous activities, and time spent sitting. Calculation of the total score of the short form includes the sum of the duration (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous activity. The energy required for activities is calculated with the metabolic equivalent(MET) -minute score. Standard metabolic equivalent (MET) values have been established for these activities.
Menstruation Symptom Scale
It is a 5-point Likert-type scale and consists of three sub-parameters: 'negative effects/somatic effects', 'menstrual pain' and 'coping methods', and 22 items. The person is asked to give a score between '1' never and '5' always for the symptoms they experience related to menstruation. The Menstruation Symptom Scale (MSS) score is calculated by taking the total score average. An increase in the mean score indicates an increase in the severity of menstrual symptoms.
Menstruation Distress Complaints List
He questions the severity of these symptoms one week before the menstruation, during the last menstruation, and on other days. Complaints are scored from 0 to 4. These are 0: no symptoms, 1: little, 2: moderate, 3: severe, and 4: very severe. The lowest score that can be obtained from the scale is 0 for each term, and the highest score is 188.

Secondary Outcome Measures

Full Information

First Posted
August 17, 2023
Last Updated
September 1, 2023
Sponsor
Uskudar University
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1. Study Identification

Unique Protocol Identification Number
NCT06006507
Brief Title
Examination of Menstruation Symptoms in Women Who Exercise Regularly.
Official Title
Examination of Menstruation Symptoms in Women Who Exercise Regularly.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar University

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study is to contribute to the determination of the relationship between exercise and menstrual symptoms and to create an alternative for non-pharmacological coping methods with menstrual symptoms.
Detailed Description
The type of research is randomized controlled trial. An average of 50 people who do not have exercise habits will participate in the study, and two randomized groups will be formed as exercise group and control group. Everyone will be asked to fill in the Menstruation Symptom Scale, the Menstruation Distress Scale, the Pittsburgh Sleep Quality Scale, the Fatigue Severity Scale, the International Physical Activity Scale, the Personal Information Form prepared by us, and the Voluntary and Consent Form during their menstrual period. The duration of the study will cover 3 (three) menstrual periods of the individuals. At the beginning and end of the study; They will be asked to fill in the Pittsburgh Sleep Quality Scale, Fatigue severity scale, International Physical Activity Questionnaire Short form, Menstruation Symptom Scale and Menstruation Distress Complaint List.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstrual Problem
Keywords
sleep, menstruation, stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Exercise treatments
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
no exercise will be given
Arm Title
exercise group
Arm Type
Experimental
Arm Description
exercise training will be given and they will be asked to exercise regularly.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
no exercise will be given
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
In line with the recommendation of the World Health Organization, the exercise group will do 150 minutes of moderate-intensity walking a week and strengthening exercises prepared by the physiotherapist two days a week. Strengthening exercises will be taught by the physiotherapist in a session with the people in the exercise group in groups of five, and then exercise lists will be given to the people on digital exercise platform, where there are video narrations of the exercises. In addition, the participants will be asked to do balance exercises and macular exercise.
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Scale
Description
The pittsburgh Sleep Quality Index is a quantitative measure of sleep quality to define good and bad sleep. It includes 24 questions in total. The self-assessment questions include various items related to sleep quality. The total score is between 0-21. A high total score indicates poor sleep quality. The index does not indicate the presence of sleep disturbances or the prevalence of sleep disturbances. However, a pittsburgh Sleep Quality Index total score of five or more indicates poor sleep quality.
Time Frame
14 weeks
Title
Fatigue Severity Scale
Description
It consists of 9 questions. Each question is scored between 1 and 7. Statements Regarding Scoring 1. I strongly disagree 3. I tend to disagree 5. I tend to agree 2. I disagree 4. I am undecided 6. I agree 7. I strongly agree. ) the score of the answers given to the question is added and divided by 9. If the result is less than 2.8, it is evaluated as "no fatigue". If the result is greater than 6.1, it is considered as "chronic fatigue syndrome".
Time Frame
14 weeks
Title
Short form of the International Physical Activity Questionnaire
Description
provides information on time spent walking, moderate and vigorous activities, and time spent sitting. Calculation of the total score of the short form includes the sum of the duration (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous activity. The energy required for activities is calculated with the metabolic equivalent(MET) -minute score. Standard metabolic equivalent (MET) values have been established for these activities.
Time Frame
14 weeks
Title
Menstruation Symptom Scale
Description
It is a 5-point Likert-type scale and consists of three sub-parameters: 'negative effects/somatic effects', 'menstrual pain' and 'coping methods', and 22 items. The person is asked to give a score between '1' never and '5' always for the symptoms they experience related to menstruation. The Menstruation Symptom Scale (MSS) score is calculated by taking the total score average. An increase in the mean score indicates an increase in the severity of menstrual symptoms.
Time Frame
14 weeks
Title
Menstruation Distress Complaints List
Description
He questions the severity of these symptoms one week before the menstruation, during the last menstruation, and on other days. Complaints are scored from 0 to 4. These are 0: no symptoms, 1: little, 2: moderate, 3: severe, and 4: very severe. The lowest score that can be obtained from the scale is 0 for each term, and the highest score is 188.
Time Frame
14 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
menstrual cycle Female only
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women between the ages of 18-50 whose menstrual cycle continues, Those who have emotional or physical problems during menstruation periods, Those whose menstrual cycle is between 21-40 days on average Exclusion Criteria: Those with chronic disease Those with a diagnosed gynecological disease, Those who receive any medical treatment, Persons with dysmenorrhea and anemia. People who exercise regularly.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ömer ŞEVGİN
Phone
+905069787535
Email
omer.sevgin@uskudar.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merve KOÇAK
Organizational Affiliation
Bahçeşehir University
Official's Role
Study Chair
Facility Information:
Facility Name
Üsküdar Unıversıty
City
Beşiktaş
State/Province
İstanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ömer ŞEVGİN
Phone
+905069787535
Email
omer.sevgin@uskudar.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36403515
Citation
Eccleston CA, Goldenholz SR, Goldenholz DM. Exercise, medication adherence, and the menstrual cycle: How much do these change seizure risk? Epilepsy Res. 2022 Dec;188:107052. doi: 10.1016/j.eplepsyres.2022.107052. Epub 2022 Nov 15.
Results Reference
background
PubMed Identifier
12959622
Citation
Janse de Jonge XA. Effects of the menstrual cycle on exercise performance. Sports Med. 2003;33(11):833-51. doi: 10.2165/00007256-200333110-00004.
Results Reference
background
PubMed Identifier
20199120
Citation
Oosthuyse T, Bosch AN. The effect of the menstrual cycle on exercise metabolism: implications for exercise performance in eumenorrhoeic women. Sports Med. 2010 Mar 1;40(3):207-27. doi: 10.2165/11317090-000000000-00000.
Results Reference
background
PubMed Identifier
32670076
Citation
Pereira HM, Larson RD, Bemben DA. Menstrual Cycle Effects on Exercise-Induced Fatigability. Front Physiol. 2020 Jun 26;11:517. doi: 10.3389/fphys.2020.00517. eCollection 2020.
Results Reference
background
PubMed Identifier
31690491
Citation
Nie J, Zhang H, Kong Z, Wang C, Liu Y, Shi Q, George K. The impact of exercise modality and menstrual cycle phase on circulating cardiac troponin T. J Sci Med Sport. 2020 Mar;23(3):309-314. doi: 10.1016/j.jsams.2019.10.003. Epub 2019 Oct 10.
Results Reference
background

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Examination of Menstruation Symptoms in Women Who Exercise Regularly.

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