NCT06006507

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

August 17, 2023

Last Update Submit

September 18, 2024

Conditions

Keywords

sleepmenstruationstress

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

control group

ACTIVE COMPARATOR

no exercise will be given

Other: control

exercise group

EXPERIMENTAL

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

Other: exercise

Interventions

controlOTHER

no exercise will be given

control group

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.

exercise group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsmenstrual cycle Female only
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Üsküdar Unıversıty

Beşiktaş, Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Kocak M, Sevgin O. The effect of exercise on menstrual symptoms: a randomized controlled trial. BMC Womens Health. 2025 Aug 23;25(1):406. doi: 10.1186/s12905-025-03940-8.

MeSH Terms

Conditions

Menstruation Disturbances

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Merve KOÇAK

    Bahçeşehir University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Exercise treatments
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 23, 2023

Study Start

September 1, 2023

Primary Completion

December 15, 2023

Study Completion

December 20, 2023

Last Updated

September 20, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations