The Effect of Exercise on Menstrual Symptoms

September 18, 2024 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University

The Effect of Exercise on Menstrual Symptoms: a Randomised Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • İstanbul
      • Beşiktaş, İstanbul, Turkey
        • Üsküdar Unıversıty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: control group
no exercise will be given
Other: control
no exercise will be given
Experimental: exercise group
exercise training will be given and they will be asked to exercise regularly.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Scale
Time Frame: 14 weeks
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
Time Frame: 14 weeks
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
Time Frame: 14 weeks
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
Time Frame: 14 weeks
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
Time Frame: 14 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uskudar University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Merve KOÇAK, Bahçeşehir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Uskudar58

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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