Biomechanical Changes During Menstrual Cycle

December 1, 2020 updated by: Piotr Michalik, Medical University of Silesia

Biomechanical Changes in Young Women During Menstrual Cycle

The aim of the work is to assess the effect of the menstrual cycle on the biomechanical properties of the muscles. The study will be conducted among young women aged 20-25 with a regular menstrual cycle. During the test, muscle strength and muscle flexibility as well as activation times will be performed. The study will assess the effect of the stretching of the hamstring muscles on the biomechanical properties of the muscles in the different phases of the menstrual cycle.

Study Overview

Status

Status

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

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.

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 (Anticipated)

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.
500

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 Contact Backup

Study Locations

  • Poland
    • Śląskie
      • Katowice, Śląskie, Poland, 40-752
        • Recruiting
        • Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia, Katowice, Poland

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

20 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Regular menstrual cycle lasting 28 days (+/- 5 days)
  • A menstrual cycle that has been present for at least 2 years
  • No hormonal contraception
  • Lack of pain in the lower spine
  • No restriction of mobility in the hip joint

Exclusion Criteria:

  • Irregular menstrual cycle
  • BMI value below 18.5 and above 25
  • Orthopedic disorders in the lower limb
  • Neurological disorders
  • Normal flexibility of the hamstring muscles

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group 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.
Experimental: Young women during various of phases of menstrual cycle.
The group of 40 young women will have their hamstring muscle stretched in different phases of the menstrual cycle: follicular, ovulatory and luteal. Static stretching will last 3x 45 seconds with a 15 second break between repetitions. Before and after the intervention a series of tests will be performed.
Procedure: Static stretching
Static stretching lasting 3 x 45 seconds will be performed in each of the examined women three times in different phases of the menstrual cycle: follicular, ovulatory and luteal. Before and after the intervention, a series of tests assessing the influence of stretching on biomechanical parameters will be carried out

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
Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during follicular phase of menstrual cycle
Hamstring flexibility will be assessed using AKE and PKE and SLR tests.
Change measured before and immediately after static stretching during follicular phase of menstrual cycle
Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
Hamstring flexibility will be assessed using AKE and PKE and SLR tests.
Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during luteal phase of menstrual cycle
Hamstring flexibility will be assessed using AKE and PKE and SLR tests.
Change measured before and immediately after static stretching during luteal phase of menstrual cycle
Passive Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during follicular phase of menstrual cycle
Hamstring flexibility will be assessed using PKE test
Change measured before and immediately after static stretching during follicular phase of menstrual cycle
Passive Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
Hamstring flexibility will be assessed using PKE test
Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
Passive Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during luteal phase of menstrual cycle
Hamstring flexibility will be assessed using PKE test
Change measured before and immediately after static stretching during luteal phase of menstrual cycle
Active Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during follicular phase of menstrual cycle
Hamstring flexibility will be assessed using SLR tests.
Change measured before and immediately after static stretching during follicular phase of menstrual cycle
Active Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
Hamstring flexibility will be assessed using SLR tests.
Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
Active Hamstring flexibility
Time Frame: Change measured before and immediately after static stretching during luteal phase of menstrual cycle
Hamstring flexibility will be assessed using SLR tests.
Change measured before and immediately after static stretching during luteal phase of menstrual cycle
Hamstring passive stifness
Time Frame: Change measured before and immediately after static stretching during follicular phase of menstrual cycle
Hamstring stiffness will be assessed using TDK test. During the test the resistance of the elongated Hamstring muscle is measured. If the resistance value is smaller after the intervention it means that muscle stiffness changed.
Change measured before and immediately after static stretching during follicular phase of menstrual cycle
Hamstring passive stifness
Time Frame: Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
Hamstring stiffness will be assessed using TDK test. During the test the resistance of the elongated Hamstring muscle is measured. If the resistance value is smaller after the intervention it means that muscle stiffness changed.
Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
Hamstring passive stifness
Time Frame: Change measured before and immediately after static stretching during luteal phase of menstrual cycle
Hamstring stiffness will be assessed using TDK test. During the test the resistance of the elongated Hamstring muscle is measured. If the resistance value is smaller after the intervention it means that muscle stiffness changed.
Change measured before and immediately after static stretching during luteal phase of menstrual cycle
Trunk acivity is assessed using Stabilizer Pressure Biofeedback
Time Frame: Three repetitions with a 30-second break between. The measure is taken during follicular phase of menstrual cycle
The torso activation scheme is measured during lower and upper limb motions using Chattanooga Stabilizer Pressure Biofeedback.
Three repetitions with a 30-second break between. The measure is taken during follicular phase of menstrual cycle
Trunk acivity is assessed using Stabilizer Pressure Biofeedback
Time Frame: Three repetitions with a 30-second break between. The measure is taken during ovulation phase of menstrual cycle
The torso activation scheme is measured during lower and upper limb motions using Chattanooga Stabilizer Pressure Biofeedback.
Three repetitions with a 30-second break between. The measure is taken during ovulation phase of menstrual cycle
Trunk acivity is assessed using Stabilizer Pressure Biofeedback
Time Frame: Three repetitions with a 30-second break between. The measure is taken during luteal phase of menstrual cycle
The torso activation scheme is measured during lower and upper limb motions using Chattanooga Stabilizer Pressure Biofeedback.
Three repetitions with a 30-second break between. The measure is taken during luteal phase of menstrual cycle
Hamstring strength is tested using the Micro Fet Handheld Dynamometer.
Time Frame: Change measured before and immediately after static stretching. The measure is taken during follicular phase of menstrual cycle
Muscle strength of hamstring is tested. Three repetitions of muscle strength testing are performed with two 30-second intervals. The participants are asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
Change measured before and immediately after static stretching. The measure is taken during follicular phase of menstrual cycle
Hamstring strength is tested using the Micro Fet Handheld Dynamometer.
Time Frame: Change measured before and immediately after static stretching. The measure is taken during ovulation phase of menstrual cycle
Muscle strength of hamstring is tested. Three repetitions of muscle strength testing are performed with two 30-second intervals. The participants are asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
Change measured before and immediately after static stretching. The measure is taken during ovulation phase of menstrual cycle
Hamstring strength is tested using the Micro Fet Handheld Dynamometer.
Time Frame: Change measured before and immediately after static stretching. The measure is taken during luteal phase of menstrual cycle
Muscle strength of hamstring is tested. Three repetitions of muscle strength testing are performed with two 30-second intervals. The participants are asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
Change measured before and immediately after static stretching. The measure is taken during luteal phase of menstrual cycle
Strength of arm flexors and extensors and hip flexors is tested using the Micro Fet Handheld Dynamometer.
Time Frame: Three repetitions for 5-7 seconds with two 30-second intervals . The measure is taken during follicular phase of menstrual cycle
Muscle strength of arm flexors and extensors and hip flexors is tested. Three repetitions of muscle strength testing are performed with two 30-second intervals. The participants are asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
Three repetitions for 5-7 seconds with two 30-second intervals . The measure is taken during follicular phase of menstrual cycle
Strength of arm flexors and extensors and hip flexors is tested using the Micro Fet Handheld Dynamometer.
Time Frame: Three repetitions for 5-7 seconds with two 30-second intervals . The measure is taken during ovulation phase of menstrual cycle
Muscle strength of arm flexors and extensors and hip flexors is tested. Three repetitions of muscle strength testing are performed with two 30-second intervals. The participants are asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
Three repetitions for 5-7 seconds with two 30-second intervals . The measure is taken during ovulation phase of menstrual cycle
Strength of arm flexors and extensors and hip flexors is tested using the Micro Fet Handheld Dynamometer.
Time Frame: Three repetitions for 5-7 seconds with two 30-second intervals . The measure is taken during luteal phase of menstrual cycle
Muscle strength of arm flexors and extensors and hip flexors is tested. Three repetitions of muscle strength testing are performed with two 30-second intervals. The participants are asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
Three repetitions for 5-7 seconds with two 30-second intervals . The measure is taken during luteal phase of menstrual cycle

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.
Medical University of Silesia

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: Magdalena Dąbrowska-Galas, Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia

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.
August 1, 2018

Primary Completion (Anticipated)

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.
May 1, 2021

Study Completion (Anticipated)

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.
November 1, 2021

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).
February 13, 2019

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.
June 6, 2019

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.
June 7, 2019

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.
December 2, 2020

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.
December 1, 2020

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.
December 1, 2020

More Information

Terms related to this study

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.
  • stretching w cyklu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.

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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