Premenstrual SyndromeNCT06191536
The Effect of PVE Applied in Addition to Pilates on Premenstrual Symptoms, Pain, Sleep and QoL in Individuals With PMS
A study testing Pilates and Pelvic floor exercises in people with Premenstrual Syndrome and Pelvic Floor Disorders, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
Premenstrual syndrome (PMS) is a condition that occurs with physical and psychological symptoms in the late luteal phase of the menstrual cycle in women and affects the physical and mental well-being of the individual. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome, Pelvic Floor Disorders, Quality of Life
- What is being tested?
- Pilates and Pelvic floor exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2013to 20 Jul 2024
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be willing to participate in research
- Getting a score of 111 or higher on the PMS Scale,
- Experiencing premenstrual symptoms for at least 3 months,
- Having a pain score of at least 4 on the Visual Analogue Scale during any menstrual period within the last 3 months.
- Regular menstrual cycle for 12 months (24-35 days),
Who cannot join
- Being under 18 years of age,
- Change in menstrual characteristics after PMS diagnosis,
- Having a chronic or physical illness that prevents you from doing Pilates.
- People who have had surgery in the last 6 months,
- Individuals with musculoskeletal system problems,
- Individuals with chronic diseases,
Show all 10Show fewer
- People receiving hormone therapy,
- Pregnant individuals,
- People with urinary, genital or gastrointestinal disorders,
- People who have had hysterectomy surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of PVE Applied in Addition to Pilates on Premenstrual Symptoms, Pain, Sleep and QoL in Individuals With Premenstrual Syndrome
Premenstrual syndrome (PMS) is a condition that occurs with physical and psychological symptoms in the late luteal phase of the menstrual cycle in women and affects the physical and mental well-being of the individual. Physiological symptoms; edema, headache, fatigue, weight gain and breast swelling and tenderness, and psychological symptoms; It can be seen as tension, anger, depressed mood or stress. Although it usually ends with the onset of menstruation, its repetition with each menstrual cycle affects the individual's pain coping strategies, sleep and quality of life.
Different methods such as pharmacological agents, physiotherapy applications, nutrition and lifestyle adjustments, breathing exercises, stress management, meditation and cognitive behavioral therapy are used to cope with PMS, which appears with symptoms of different severities from individual to individual.
Read the detailed description
Exercise; It is known to have positive physical and psychological effects on PMS symptoms by reducing muscle cramps, increasing circulation and controlling the neuromuscular system. Pilates, as an exercise method that combines body-mind conditioning with breathing control and focuses on lumbopelvic stability and targets core stabilization, is also thought to have a significant effect on increasing pelvic floor muscle strength by performing it together with pelvic floor muscle contraction. In addition, considering the anatomical connection of the pelvic floor muscles with other core muscles, it has been observed that pelvic floor muscle contractions also occur during abdominal muscle contraction. The pelvic floor consists of a group of muscles and connective tissues that extend like a sling across the pelvic floor; It consists of two layers, the superficial perineal muscles and the deep pelvic diaphragm, and provides support to the pelvic organs, bladder and elements of the spine. Pelvic floor exercises are a safe and effective means of decreasing the symptoms and signs of pelvic disorders. In the literature, it is seen that these exercises are effective in urinary incontinence.
There is no study examining the effect of pelvic floor muscle training combined with pilates on PMS symptoms. The purpose of this study; To examine the effects of pelvic floor exercises, in addition to pilates exercises, on PMS symptoms, pain, sleep and quality of life in individuals with premenstrual syndrome.
- Being tested
- Pilates, Pelvic floor exercises
- Keywords
- Premenstrual Syndrome, Pelvic Floor Exercises, Pilates, Quality of Life, Pain
- Medical subject headings
- Premenstrual Syndrome, Pelvic Floor Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesOther
Pelvic floor exercisesOther
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group (PG) | Experimental | Pilates exercises will be performed under the supervision of a certified pilates instructor.
Pilates exercises will be performed for 50 minutes, 2 days a week for 8 weeks. Receives: Other: Pilates |
| Pelvic Floor Exercise Group (PFEG) | Active comparator | It consists of voluntary pelvic floor muscle contractions applied in addition to pilates exercises.
Pelvic floor muscle contractions involve maximum contraction of the pelvic floor muscles alternately for five repetitions during exhalation.
Pelvic floor exercises will be applied under the supervision of a pelvic floor certified physiotherapist.
In addition to pilates exercises, pelvic floor exercises will be applied 2 days a week, 50 minutes, for 8 weeks. Receives: Other: Pilates; Other: Pelvic floor exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual Syndrome Scale (PMSS)
The Premenstrual Syndrome Scale (PMSS) is a 44-item questionnaire based on a five-point Likert-type scale with scores ranging from 1 to 5. (Never, Rarely, Sometimes, Often, Constantly) Pmss has nine subscales, including Depressive Affects, Anxiety, Fatigue, Irritability, Depressive Thoughts, Pain, Appetite Changes, Sleep Changes, and Swelling. The PMSS total score is the sum of the scores of these nine subscales. The lowest score that can be obtained from the scale is 44 and the highest score is 220. The higher the score, the greater the intensity of PMS symptoms. In order to be diagnosed with PMS, it is necessary to get 50% of the total score (111 points).
Measured: 6 months
Secondary outcomes (3)
SF-12
Similar to SF-36, SF-12 includes physical functionality (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social functionality (1 item). It consists of 8 subscales and 12 items, including emotional role (2 items) and mental health (2 items). While items related to physical and emotional roles are answered as dikatomis (yes or no), other items have Likert-type options ranging from 3 to 6. It is possible to obtain separate scores for each subscale, the score of the subscales varies between 0 and 100, with a higher score representing better health.
Measured: 6 Months
Pittsburgh Sleep Qualıty Index (PUKI)
PSQI is a sleep questionnaire that helps evaluate the person's sleep quality, amount of sleep, and the presence and severity of sleep disorders for the last month.
This scale has 19 items and measures seven subcomponents of sleep quality, including subjective sleep quality, time to fall asleep, sleep duration, habitual sleep efficiency, sleep disturbances, sleeping pill use, and daytime dysfunction. The total PSQI score is obtained by summing the seven subscores and the total score is between 0-21. Each component is evaluated on a scale of 0-3 points. PSQI total score clearly distinguishes good sleepers (PSQI total score ≤5) from poor sleepers (PSQI >5).
Measured: 6 months
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) is an evaluation method used to convert the pain perception level, which cannot be measured numerically, into a numerical form. In the evaluation, two extreme definitions of pain were written at both ends of a 100 mm line (I have no pain at one end, the most unbearable pain at the other end). The patient was asked to indicate where his/her current situation corresponds to on this line by drawing a line, placing a dot, or pointing. The distance from the point where there was no pain to the point marked by the patient, measured in mm with a ruler, showed the patient's pain level. Pain level was recorded as activity and rest VAS in the absence of bleeding.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Dec 2013
- Primary completion20 Jul 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Premenstrual SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, osman coban, Uskudar University
- Investigators
- osman coban, PhD, Principal investigator, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191536
- Sponsor's protocol ID
- UskudarUniversitesi
- Status last verified
- Sep 2024
- First submitted
- 20 Dec 2023
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results of the study will be shared.
Publications
Culligan PJ, Scherer J, Dyer K, Priestley JL, Guingon-White G, Delvecchio D, Vangeli M. A randomized clinical trial comparing pelvic floor muscle training to a Pilates exercise program for improving pelvic muscle strength. Int Urogynecol J. 2010 Apr;21(4):401-8. doi: 10.1007/s00192-009-1046-z. Epub 2010 Jan 22.
PubMed 20094704Leite A, Matignon A, Marlot L, Coelho A, Lopes S, Brochado G. The Impact of Clinical Pilates Exercises on Tension-Type Headaches: A Case Series. Behav Sci (Basel). 2023 Jan 27;13(2):105. doi: 10.3390/bs13020105.
PubMed 36829334Yaray O, Akesen B, Ocaklioglu G, Aydinli U. Validation of the Turkish version of the visual analog scale spine score in patients with spinal fractures. Acta Orthop Traumatol Turc. 2011;45(5):353-8. doi: 10.3944/AOTT.2011.2528.
PubMed 22033000Soylu C, Kutuk B. Reliability and Validity of the Turkish Version of SF-12 Health Survey. Turk Psikiyatri Derg. 2022 Summer;33(2):108-117. doi: 10.5080/u25700. English, Turkish.
PubMed 35730511
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of PVE Applied in Addition to Pilates on Premenstrual Symptoms, Pain, Sleep and QoL in Individuals With Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT06191536
- Acronym / sponsor ID
- UskudarUniversitesi
- Keywords
- Premenstrual Syndrome, Pelvic Floor Exercises, Pilates, Quality of Life, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 5 Jan 2024 (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.
Premenstrual syndrome (PMS) is a condition that occurs with physical and psychological symptoms in the late luteal phase of the menstrual cycle in women and affects the physical and mental well-being of the individual. Physiological symptoms; edema, headache, fatigue, weight gain and breast swelling and tenderness, and psychological symptoms; It can be seen as tension, anger, depressed mood or stress. Although it usually ends with the onset of menstruation, its repetition with each menstrual cycle affects the individual's pain coping strategies, sleep and quality of life.
Different methods such as pharmacological agents, physiotherapy applications, nutrition and lifestyle adjustments, breathing exercises, stress management, meditation and cognitive behavioral therapy are used to cope with PMS, which appears with symptoms of different severities from individual to individual.
Detailed description
Exercise; It is known to have positive physical and psychological effects on PMS symptoms by reducing muscle cramps, increasing circulation and controlling the neuromuscular system. Pilates, as an exercise method that combines body-mind conditioning with breathing control and focuses on lumbopelvic stability and targets core stabilization, is also thought to have a significant effect on increasing pelvic floor muscle strength by performing it together with pelvic floor muscle contraction. In addition, considering the anatomical connection of the pelvic floor muscles with other core muscles, it has been observed that pelvic floor muscle contractions also occur during abdominal muscle contraction. The pelvic floor consists of a group of muscles and connective tissues that extend like a sling across the pelvic floor; It consists of two layers, the superficial perineal muscles and the deep pelvic diaphragm, and provides support to the pelvic organs, bladder and elements of the spine. Pelvic floor exercises are a safe and effective means of decreasing the symptoms and signs of pelvic disorders. In the literature, it is seen that these exercises are effective in urinary incontinence.
There is no study examining the effect of pelvic floor muscle training combined with pilates on PMS symptoms. The purpose of this study; To examine the effects of pelvic floor exercises, in addition to pilates exercises, on PMS symptoms, pain, sleep and quality of life in individuals with premenstrual syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Pilates Group (PG) | Experimental | Other: PilatesPilates exercises will be performed under the supervision of a certified pilates instructor. Pilates exercises will be performed for 50 minutes, 2 days a week for 8 weeks. |
| Pelvic Floor Exercise Group (PFEG) | Active comparator | Other: Pilates, Other: Pelvic floor exercisesIt consists of voluntary pelvic floor muscle contractions applied in addition to pilates exercises. Pelvic floor muscle contractions involve maximum contraction of the pelvic floor muscles alternately for five repetitions during exhalation. Pelvic floor exercises will be applied under the supervision of a pelvic floor certified physiotherapist. In addition to pilates exercises, pelvic floor exercises will be applied 2 days a week, 50 minutes, for 8 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be willing to participate in research
- Getting a score of 111 or higher on the PMS Scale,
- Experiencing premenstrual symptoms for at least 3 months,
- Having a pain score of at least 4 on the Visual Analogue Scale during any menstrual period within the last 3 months.
- Regular menstrual cycle for 12 months (24-35 days),
Key exclusion criteria (10 listed)
- Being under 18 years of age,
- Change in menstrual characteristics after PMS diagnosis,
- Having a chronic or physical illness that prevents you from doing Pilates.
- People who have had surgery in the last 6 months,
- Individuals with musculoskeletal system problems,
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 |
|---|---|---|
| Pilates | Other | Pelvic Floor Exercise Group (PFEG), Pilates Group (PG) |
| Pelvic floor exercises | Other | Pelvic Floor Exercise Group (PFEG) |
Primary outcome
Premenstrual Syndrome Scale (PMSS)
Time frame: 6 months
The Premenstrual Syndrome Scale (PMSS) is a 44-item questionnaire based on a five-point Likert-type scale with scores ranging from 1 to 5. (Never, Rarely, Sometimes, Often, Constantly) Pmss has nine subscales, including Depressive Affects, Anxiety, Fatigue, Irritability, Depressive Thoughts, Pain, Appetite Changes, Sleep Changes, and Swelling. The PMSS total score is the sum of the scores of these nine subscales. The lowest score that can be obtained from the scale is 44 and the highest score is 220. The higher the score, the greater the intensity of PMS symptoms. In order to be diagnosed with PMS, it is necessary to get 50% of the total score (111 points).
3 secondary outcomes
SF-12
Time frame: 6 Months
Pittsburgh Sleep Qualıty Index (PUKI)
Time frame: 6 months
Visual Analogue Scale (VAS)
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Background: PubMed 20094704Culligan PJ, Scherer J, Dyer K, Priestley JL, Guingon-White G, Delvecchio D, Vangeli M. A randomized clinical trial comparing pelvic floor muscle training to a Pilates exercise program for improving pelvic muscle strength. Int Urogynecol J. 2010 Apr;21(4):401-8. doi: 10.1007/s00192-009-1046-z. Epub 2010 Jan 22.
- Background: PubMed 36829334Leite A, Matignon A, Marlot L, Coelho A, Lopes S, Brochado G. The Impact of Clinical Pilates Exercises on Tension-Type Headaches: A Case Series. Behav Sci (Basel). 2023 Jan 27;13(2):105. doi: 10.3390/bs13020105.
- Background: PubMed 22033000Yaray O, Akesen B, Ocaklioglu G, Aydinli U. Validation of the Turkish version of the visual analog scale spine score in patients with spinal fractures. Acta Orthop Traumatol Turc. 2011;45(5):353-8. doi: 10.3944/AOTT.2011.2528.
- Background: PubMed 35730511Soylu C, Kutuk B. Reliability and Validity of the Turkish Version of SF-12 Health Survey. Turk Psikiyatri Derg. 2022 Summer;33(2):108-117. doi: 10.5080/u25700. English, Turkish.
- Individual participant dataSharing planned: No. The results of the study will be shared.
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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.
osman coban, PhD principal investigator
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates and Pelvic floor exercises in people with Premenstrual Syndrome and Pelvic Floor Disorders, run by Uskudar University at 1 site in Turkey (Türkiye).
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 10 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: finished, as of the sponsor's last update on 26 Sep 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premenstrual Syndrome Scale (PMSS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06191536, which also lists 4 linked publications.
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 26 Sep 2024.