NCT03979326

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

December 2, 2020

Status Verified

December 1, 2020

Enrollment Period

2.8 years

First QC Date

February 13, 2019

Last Update Submit

December 1, 2020

Conditions

Outcome Measures

Primary Outcomes (21)

  • Hamstring flexibility

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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.

    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.

    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.

    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.

    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.

    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.

    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

Study Arms (1)

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.

Procedure: Static stretching

Interventions

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

Young women during various of phases of menstrual cycle.

Eligibility Criteria

Age20 Years - 26 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia, Katowice, Poland

Katowice, Silesian Voivodeship, 40-752, Poland

RECRUITING

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Magdalena Dąbrowska-Galas

    Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia

    STUDY CHAIR

Central Study Contacts

Tomasz Michalski

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 13, 2019

First Posted

June 7, 2019

Study Start

August 1, 2018

Primary Completion

May 1, 2021

Study Completion

November 1, 2021

Last Updated

December 2, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

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

Locations