Resistive Exercise and Stretching in Women With Dysmenorrhea

July 12, 2024 updated by: METEHAN YANA, Karabuk University

Comparison of the Effects of Resistant Exercise and Stretching Exercises on Menstrual Symptoms, Quality of Life, Functional and Emotional Status in Young Women With Primary Dysmenorrhea

This study highlights the importance of exercise for young women with primary dysmenorrhea. Exercise can help relieve the symptoms of dysmenorrhea by increasing blood flow and promoting the release of endorphins. Additionally, exercise can improve the overall quality of life by reducing stress and anxiety. A comprehensive comparison of the effects of especially resistant exercises and stretching exercises on menstrual pain is based on limited findings in the literature. Therefore, this study aims to make a significant contribution to clinical practice by evaluating the effectiveness and feasibility of these exercise types.

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

Primary dysmenorrhea is a common condition that seriously affects women's quality of life, and alternative methods other than pharmacotherapy are often investigated. Exercise may play a potential role in reducing the symptoms of dysmenorrhea by increasing blood flow and promoting the release of endorphins. Additionally, exercise can improve the overall quality of life by reducing stress and anxiety. However, studies comparing the specific effects of resistance exercises and stretching exercises on dysmenorrhea are limited and do not provide clear guidance on this subject. The aim of this study is to evaluate the effectiveness and feasibility of these two types of exercise in young women with primary dysmenorrhea. The results of the research can guide healthcare professionals by providing information on which type of exercise may be more effective in clinical practice. The importance of exercise as a non-pharmacological treatment option is emphasized, and it is aimed at making a significant contribution to the wide acceptance and application of such treatments.

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 Locations

  • Turkey
      • Karabük, Turkey, 78000
        • Karabuk 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:

  • Having a score of 60 points or above on the menstrual symptoms scale
  • Having a regular menstrual cycle (24-35 days)
  • Not doing any exercise regularly
  • Being between the ages of 18 and 25
  • Nulliparity
  • Being cooperative and oriented
  • Volunteering to participate in the study

Exclusion Criteria:

  • Having a medical history of chronic disease (cardiopulmonary, neurological, thyroid gland diseases)
  • Having a history of regular exercise
  • Engaging in regular sexual activity
  • Having undergone gynecological surgical procedures
  • Using hormonal contraceptive drugs or intrauterine devices
  • Using a drug that causes dysmenorrhea
  • Pelvic pathology, pelvic inflammatory diseases, endometriosis, etc. Having a disease that causes secondary dysmenorrhea
  • Using antidepressant medication
  • Having acute musculoskeletal system problems

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: Resisted Exercise group
Participants underwent resistance training for 8 weeks, focusing on trunk, upper, and lower body segments with 10-12 reps per exercise at 30-65% intensity. Sessions lasted 50-60 minutes, 3 times weekly
Other: Resisted Exercise group
The resisted exercise training program targeted trunk, upper, and lower body segments with 10-12 repetitions at 30-65% intensity, lasting 50-60 minutes per session, 3 times weekly for 8 weeks. Participants determined their maximal repetition through trial training. Maximal power was assessed using concentric 1-maximal repetition (MT). Following a 2-3 minute rest and a 5-minute warm-up (walking), participants performed the 1-MT test to establish their heaviest lift with the correct technique, adjusting resistance levels accordingly. The circuit-style training spanned 9 stations with 2-3 sets per station, each circuit lasting 2-3 minutes with 90-second rests between sets. A 5-minute warm-up and cool-down (walking) preceded and followed each session. Exercises included bilateral elbow flexion, chest press, bilateral shoulder abduction, bilateral knee extension, back extension, sit-ups, knee flexion, hip abduction, and hip adduction.
Active Comparator: Stretching Exercise group
The participants were made to perform stretching exercises, selected by reviewing the literature, under supervision 3 days a week for 8 weeks, and they were asked not to do any other exercises during this intervention period.
Other: Stretching Exercise group
The participants were made to perform stretching exercises, selected by reviewing the literature, under supervision 3 days a week for 8 weeks, and they were asked not to do any other exercises during this intervention period. They were asked to do exercises such as trunk flexion, pelvic elevation, squatting, trunk lateral flexion, lumbar extensor stretching, lower abdominal stretching, hip adduct stretching, piriformis stretching, and trunk flexor stretching (cobra pose). The holding time was 5 seconds, the rest time was 1 second, and the exercises were applied in 10 repetitions.
No Intervention: control group
No treatment was applied to the control group; they were allowed to use painkillers and continued their normal daily lives.

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
Visual Analog Scale
Time Frame: At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
Lower abdomen, leg and low back pain were evaluated with the Visual Analog Scale
At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
Menstrual symptoms questionnaire
Time Frame: At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
menstrual symptoms were evaluated with the Menstrual Symptoms Questionnaire
At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
Pittsburgh Sleep Quality Index
Time Frame: At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
sleep quality was evaluated with the Pittsburgh Sleep Quality Index
At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
Health-Related Quality of Life Assessment (SF 36 Short Form)
Time Frame: At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
Quality of life was evaluated with the Health-Related Quality of Life Assessment (SF 36 Short Form)
At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
Functional and Emotional Dysmenorrhea Questionnaire
Time Frame: At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
functional and emotional status was evaluated with the Functional and Emotional Dysmenorrhea Questionnaire
At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).

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.
Karabuk 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.
December 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.
February 10, 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.
February 10, 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).
June 27, 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 12, 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 15, 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 15, 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 12, 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.
  • women Health

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.

Clinical Trials on Dysmenorrhea Primary

Clinical Trials on Resisted Exercise group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings