Menstrual CycleNCT03979326
Biomechanical Changes During Menstrual Cycle
A study testing Static stretching in people with Menstrual Cycle and Passive Stretching, run by Medical University of Silesia at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle, Passive Stretching, Hamstring Muscles
- What is being tested?
- Static stretching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2018to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 26 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia, Katowice, Poland
Katowice, Silesian Voivodeship, 40-752
Magdalena Dąbrowska-Galas, Phd, 515321323 ext. 048, magdalena.j.dabrowska@gmail.com
About this study
Official title: 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.
- Conditions
- Menstrual Cycle, Passive Stretching, Hamstring Muscles
- Being tested
- Static stretching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static stretchingProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Young women during various of phases of menstrual cycle. | Experimental | 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. Receives: Procedure: Static stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamstring flexibility
Hamstring flexibility will be assessed using AKE and PKE and SLR tests.
Measured: Change measured before and immediately after static stretching during follicular phase of menstrual cycle
Hamstring flexibility
Hamstring flexibility will be assessed using AKE and PKE and SLR tests.
Measured: Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
Hamstring flexibility
Hamstring flexibility will be assessed using AKE and PKE and SLR tests.
Measured: Change measured before and immediately after static stretching during luteal phase of menstrual cycle
Passive Hamstring flexibility
Hamstring flexibility will be assessed using PKE test
Measured: Change measured before and immediately after static stretching during follicular phase of menstrual cycle
Passive Hamstring flexibility
Hamstring flexibility will be assessed using PKE test
Measured: Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
Passive Hamstring flexibility
Hamstring flexibility will be assessed using PKE test
Measured: Change measured before and immediately after static stretching during luteal phase of menstrual cycle
Active Hamstring flexibility
Hamstring flexibility will be assessed using SLR tests.
Measured: Change measured before and immediately after static stretching during follicular phase of menstrual cycle
Active Hamstring flexibility
Hamstring flexibility will be assessed using SLR tests.
Measured: Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
Active Hamstring flexibility
Hamstring flexibility will be assessed using SLR tests.
Measured: Change measured before and immediately after static stretching during luteal phase of menstrual cycle
Hamstring passive stifness
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.
Measured: Change measured before and immediately after static stretching during follicular phase of menstrual cycle
Hamstring passive stifness
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.
Measured: Change measured before and immediately after static stretching during ovulation phase of menstrual cycle
Hamstring passive stifness
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.
Measured: Change measured before and immediately after static stretching during luteal phase of menstrual cycle
Trunk acivity is assessed using Stabilizer Pressure Biofeedback
The torso activation scheme is measured during lower and upper limb motions using Chattanooga Stabilizer Pressure Biofeedback.
Measured: 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
The torso activation scheme is measured during lower and upper limb motions using Chattanooga Stabilizer Pressure Biofeedback.
Measured: 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
The torso activation scheme is measured during lower and upper limb motions using Chattanooga Stabilizer Pressure Biofeedback.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Three repetitions for 5-7 seconds with two 30-second intervals . The measure is taken during luteal phase of menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Aug 2018
- Primary completionMay 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Michalik, Medical University of Silesia
- Investigators
- Magdalena Dąbrowska-Galas, Study chair, Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979326
- Sponsor's protocol ID
- stretching w cyklu
- Status last verified
- Dec 2020
- First submitted
- 13 Feb 2019
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Changes in Young Women During Menstrual Cycle
- ClinicalTrials.gov ID
- NCT03979326
- Acronym / sponsor ID
- stretching w cyklu
- Conditions
- Menstrual Cycle, Passive Stretching, Hamstring Muscles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young women during various of phases of menstrual cycle. | Experimental | Procedure: Static stretchingThe 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. |
Who may qualify
- Ages
- 20 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static stretchingStatic 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 | Procedure or surgery | Young women during various of phases of menstrual cycle. |
Primary outcome
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.
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.
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.
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdalena Dąbrowska-Galas study chair
Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static stretching in people with Menstrual Cycle and Passive Stretching, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piotr Michalik (694979743 ext. 0048, piotrmichalikk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamstring flexibility (time frame: Change measured before and immediately after static stretching during follicular phase of menstrual cycle). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.