Effect of a Calisthenic Exercises on Premenstrual Symptoms

July 28, 2024 updated by: Duygu Şahin Altaç, Halic University

Investigation of the Effect of a Calisthenic Home Exercise Program on Premenstrual Symptoms, Pain and Sleep Quality in Young Women

The aim of this study is to examine the effects of an eight-week calisthenic home exercise program on premenstrual symptoms, pain and sleep quality in young women.

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 study was conducted on 30 volunteers who met the inclusion criteria among female students studying at Haliç University Faculty of Health Sciences. The "Premenstrual Syndrome Scale (PMSS)" was used to assess the individuals' premenstrual symptoms; the "Visual Analog Scale (VAS)" was used to assess pain for each of the abdominal, lumbar and general body pain; and the "Pittsburgh Sleep Quality Index (PSQI)" was used to assess sleep quality. Then, the participants were randomly divided into two groups as "Group 1: Control group (n=15)" and "Group 2: - Calisthenic home exercise group (n=15)". Participants in the first group were not subjected to any intervention and were asked not to participate in any exercise program for eight weeks. Participants in the second group were informed about calisthenic home exercise programs face to face and were asked to perform these exercises as home exercises for eight weeks. At the end of the treatment process, participants' PMSS, VAS and PSQI scores were re-evaluated.Statistical analysis will be performed with SPSS 24.0 program. If the data is parametric, paired sample t-test will be used for within-group evaluation; independent sample t-test will be used for between-group evaluation. If the data is non-parametric, Wilson test will be used for within-group evaluation and Mann Whitney U test will be used for between-group evaluation.

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.
30

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 Locations

  • Turkey
      • Istanbul, Turkey
        • Halic University

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

No

Description

Inclusion Criteria:

  • Being a woman between the ages of 18-25
  • Studying at Halic University Faculty of Health Sciences
  • Voluntarily participating in the study
  • Having a normal menstrual cycle
  • Not exercising
  • Having a score above the mild level on the Premenstrual Syndrome Scale

Exclusion Criteria:

  • Having a condition that prevents exercise
  • Pregnancy
  • Menopause
  • Having a gynecological disease (endometriosis, ovarian cyst, pelvic infection, myoma/uterine tumor, etc.)

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: None (Open Label)

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.
No Intervention: Group 1: Control group
Participants in the first group were not subjected to any intervention and were asked not to participate in any exercise program for eight weeks.
Experimental: Group 2: Calisthenic home exercise group
Participants in the second group were informed about calisthenic home exercise programs face to face and were asked to perform these exercises as home exercises for eight weeks.
Other: Calisthenic home exercise programs
Participants in the second group were informed about calisthenic home exercise programs face to face and were asked to perform these exercises as home exercises for eight weeks.

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
Premenstrual Syndrome Scale (PMSS)
Time Frame: at baseline and at week 8.
The scale, which is widely used in the clinic, has 44 questions that women mark considering "the state of being in the period one week before menstruation". The lowest score that can be obtained from the scale is 44; the highest score is 220. In addition, PMS severity classes can be created according to the scores obtained from the scale. Accordingly, a score of 88 and above from PMSS indicates severe PMS symptoms, and a score below 88 indicates mild PMS symptoms. Individuals who scored 88 and above from the scale were included in our study.
at baseline and at week 8.
Visual Analog Scale (VAS)
Time Frame: at baseline and at week 8.
VAS is a simple, practical, valid, reliable and repeatable measure that evaluates the pain felt by scoring it between 0-10. Participants were asked to score the pain intensity they felt between 0-10 for each of the abdominal region, lumbar region and general body pain.
at baseline and at week 8.
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: at baseline and at week 8.
The PSQI questionnaire used to assess sleep quality includes 18 items for scoring. A total PSQI score between 0-4 indicates good sleep quality, and a score between 5-21 indicates poor sleep quality.
at baseline and at week 8.

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.
Halic 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.
  • Principal Investigator: Duygu Şahin Altaç, PT, MSc., Halic 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.
February 15, 2024

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.
April 15, 2024

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.
May 15, 2024

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).
July 28, 2024

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.
July 28, 2024

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.
July 31, 2024

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.
July 31, 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.
July 28, 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.
July 1, 2024

More Information

Terms related to this study

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.
  • 28.07.2024-MÇ

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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