Examination of Menstruation Symptoms in Women Who Exercise Regularly.

Menstrual Problem Clinical Trial

Official title:

Examination of Menstruation Symptoms in Women Who Exercise Regularly.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06006507
• Other study ID #: Uskudar58
• Status: Completed
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 20, 2023

Study information

• Verified date: December 2023
• Source: Uskudar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 20, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menstrual Problem
• Menstruation Disturbances

Intervention

Other:
• control
no exercise will be given
• exercise
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.

Locations

Country	Name	City	State
Turkey	Üsküdar University	Besiktas	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Uskudar University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 weeks
Primary	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".	14 weeks
Primary	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.	14 weeks
Primary	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.	14 weeks
Primary	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.	14 weeks