Premenstrual SyndromeNCT06835062
Clinical Pilates' Impact on Fitness, Symptoms & Kinesiophobia in PMS
A study testing Recommendations for Enhancing General Well-Being and Clinical Pilates in people with Premenstrual Syndrome and Pilates Exercise, run by Atlas University at 2 sites in Turkey (Türkiye).
Trial summary
Premenstrual syndrome (PMS) is characterized by a series of somatic and psychological symptoms of varying severity that occur during the luteal phase of the menstrual cycle, affecting approximately 30% of women and resolving with menstruation. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Premenstrual Syndrome, Pilates Exercise
- What is being tested?
- Recommendations for Enhancing General Well-Being and Clinical Pilates
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 4 Mar 2024to 1 Feb 2025
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Having Premenstrual Syndrome (PMS)
- Being able to read and understand Turkish
- Willingness to participate in the study
Who cannot join
- Being in menopause or perimenopause
- Being pregnant
- Currently participating in or having engaged in a regular exercise program (other than clinical Pilates) within the past year
- Having comorbid orthopedic, musculoskeletal, psychological, or cardiovascular conditions that may affect test evaluations
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Atlas University
Istanbul
Istanbul Atlas University
Istanbul
About this study
Official title: The Effects of Clinical Pilates on Physical Fitness Parameters, Symptom Severity, and Kinesiophobia in Women With Premenstrual Syndrome.
Premenstrual syndrome (PMS) is characterized by a series of somatic and psychological symptoms of varying severity that occur during the luteal phase of the menstrual cycle, affecting approximately 30% of women and resolving with menstruation. These symptoms impact daily activities, interpersonal relationships, social engagements, work efficiency, and educational productivity. PMS manifests with physical symptoms such as breast swelling and tenderness, fatigue, headaches, and weight gain, as well as psychological and emotional symptoms such as mood disorders, irritability, and stress. Symptoms typically subside with the onset of menstruation. There is no single accepted treatment for PMS. Due to conflicting findings in studies, various treatment methods are used, including lifestyle modifications, education, stress management techniques (such as massage, reflexology, and yoga), exercise, or medical support. Regular exercise is known to improve overall well-being. It prevents the decrease in endorphin secretion during the luteal phase of the menstrual cycle and has a positive impact on PMS symptoms, particularly mood disorders, fluid retention, and breast tenderness. Pilates-based exercise training is an approach that enhances muscle stability through effective, controlled movements while strengthening muscle groups associated with pain. Clinical Pilates-based exercise training is considered a preferable method for PMS management, as it is believed to improve functional capacity, pain management, mood disorders, endurance, flexibility, symptom severity, and fear of movement in individuals with PMS. Due to the limited number of studies in the literature on PMS, our study aims to investigate the effects of a clinical Pilates-based exercise program on functional fitness parameters, symptom severity, and kinesiophobia.
- Conditions
- Premenstrual Syndrome, Pilates Exercise
- Being tested
- Recommendations for Enhancing General Well-Being, Clinical Pilates
- Keywords
- Premenstrual Syndrome, Physical Fitness, Kinesiophobia, Clinic Pilates
- Medical subject headings
- Premenstrual Syndrome, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommendations for Enhancing General Well-BeingBehavioural
- Wear comfortable clothing and lie on your back. Place one hand on your abdomen. As you inhale through your nose, direct your breath towards your hand, and exhale through your mouth.
- In the same position, place one hand on your abdomen, inhale through your nose, and expand your belly under your hand. As you exhale through your mouth, purse your lips and blow out the air from your lungs.
- Engage in brisk walking at least three times a week.
- Perform stretching exercises similar to yoga; try forward bends while standing and sitting.
- Stay active throughout the month; you can dance, swim, or ride a bike.
- Reduce your intake of tea and caffeine.
- Increase your consumption of milk.
- Drink plenty of water.
- Reduce your intake of sugar-rich snacks such as chocolate.
- Prioritize foods rich in calcium, as well as vitamins A, B, and E.
Clinical PilatesOther
In addition to the general well-being recommendations, the Clinical Pilates Group participated in a total of 16 face-to-face, clinically based Pilates exercise training sessions over eight weeks, with two sessions per week, each lasting 50 minutes. The exercise training started at the end of the menstrual cycle.
The clinical Pilates-based exercise program applied to the group was designed by the researcher. The number of repetitions, levels, and variations of the exercises were progressively adjusted by the researcher according to the participants' conditions.
During the first session, the principles of clinical Pilates were explained, following the BASI Pilates method as described by Isacowitz. Participants were taught alignment, breathing, and core engagement techniques.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Pilates Group | Experimental | Not described Receives: Behavioral: Recommendations for Enhancing General Well-Being; Other: Clinical Pilates |
| Control Group | Active comparator | Not described Receives: Behavioral: Recommendations for Enhancing General Well-Being |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition (Waist Circumference)
-Waist Circumference: Measured in centimeters using a non-elastic measuring tape at the narrowest point between the lowest rib and the anterior superior iliac spine (ASIS). It was recorded in centimeters.
Measured: 8 weeks
Body Composition (Hip Circumference)
-Hip Circumference: Measured in centimeters at the widest part of the gluteus maximus and at the level of the pubis using a measuring tape.
Measured: 8 weeks
Body Composition (Waist-to-Hip Ratio)
It is calculated by dividing the circumference of the waist by the circumference of the hips.
Measured: 8 weeks
Functional Capacity
To analyze the participants' functional capacity, the 6-Minute Walk Test (6MWT) was conducted in accordance with the American Thoracic Society (ATS) criteria.
In this test, participants were instructed to walk at their own pace without running for six minutes along a 30-meter straight corridor. Standardized encouragement phrases were used throughout the test to maintain motivation.
The test result was recorded as the total distance walked in meters.
Measured: 8 weeks
Flexibility
The Sit and Reach Test is a simple and widely used test to measure the flexibility. For the measurement, a test bench was used with the following dimensions: 32 cm in height, 35 cm in length, and 45 cm in width. A 0-50 cm measurement ruler was placed on the upper surface of the bench, extending 15 cm beyond the edge where the participants' feet were positioned. Participants were seated on the floor with their bare feet extended straight towards the test bench. The measurement was taken at the farthest point reached, where they held the position for 2 seconds. Measure the distance reached in centimeters.
Measured: 8 weeks
Endurance (Trunk Flexion Test)
The Trunk Flexion Endurance Test measures core muscle endurance, especially in the abdominals and lower back. The person sits with knees bent, leans back to 60 degrees, and holds the position as long as possible. The test stops when the person loses form or falls backward and records in seconds.
Measured: 8 weeks
Endurance (Lateral Bridge Test)
The Lateral Bridge Test measures core and lateral trunk muscle endurance, especially the obliques. The person holds a side plank position with the body straight and hips lifted. The test ends when the hips drop or the person loses form and records in seconds..
Measured: 8 weeks
Endurance (Modified Biering-Sorensen Test)
The Modified Biering-Sorensen Test measures endurance of the lower back extensor muscles. The person lies prone on a bench, with the upper body unsupported beyond the edge and legs secured. They hold a horizontal position for as long as possible. The test stops when the person can no longer maintain the position and records in seconds.
Measured: 8 weeks
Endurance (Prone Bridge Test)
The Prone Bridge Test (Plank Endurance Test) measures core stability and endurance, focusing on the abdominals, lower back, and shoulders. The person holds a forearm plank position, keeping the body straight and avoiding sagging or lifting the hips. The test ends when the person can no longer maintain proper form and records in seconds.
Measured: 8 weeks
Premenstrual Syndrome Scale
The Premenstrual Syndrome Scale consists of 44 questions and is a five-point Likert-type assessment tool with the following response options:
- - Never
- - Very little
- - Sometimes
- - Often
- - Always During the administration of the Premenstrual Syndrome Scale, participants were instructed to evaluate each item according to the period one week before menstruation, following the guidelines at the beginning of the scale. They were asked to mark the corresponding rating for each statement based on their experiences during this period.
Measured: 8 weeks
Tampa Scale for Kinesiophobia
The Tampa Scale for Kinesiophobia is a 17-item questionnaire designed to measure the fear of movement and re-injury. It uses a 4-point Likert scale, with the following response options:
- - Strongly disagree
- - Disagree
- - Agree
- - Strongly agree
A higher score on the scale indicates a greater level of kinesiophobia (fear of movement and re-injury).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start4 Mar 2024
- Primary completion30 Dec 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Kaya, Atlas University
- Investigators
- Meltem Kaya, Principal investigator, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835062
- Sponsor's protocol ID
- AtlasUmkaya04
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Clinical Pilates on Physical Fitness Parameters, Symptom Severity, and Kinesiophobia in Women With Premenstrual Syndrome.
- ClinicalTrials.gov ID
- NCT06835062
- Acronym / sponsor ID
- AtlasUmkaya04
- Conditions
- Premenstrual Syndrome, Pilates Exercise
- Keywords
- Premenstrual Syndrome, Physical Fitness, Kinesiophobia, Clinic Pilates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 19 Feb 2025 (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 characterized by a series of somatic and psychological symptoms of varying severity that occur during the luteal phase of the menstrual cycle, affecting approximately 30% of women and resolving with menstruation. These symptoms impact daily activities, interpersonal relationships, social engagements, work efficiency, and educational productivity. PMS manifests with physical symptoms such as breast swelling and tenderness, fatigue, headaches, and weight gain, as well as psychological and emotional symptoms such as mood disorders, irritability, and stress. Symptoms typically subside with the onset of menstruation. There is no single accepted treatment for PMS. Due to conflicting findings in studies, various treatment methods are used, including lifestyle modifications, education, stress management techniques (such as massage, reflexology, and yoga), exercise, or medical support. Regular exercise is known to improve overall well-being. It prevents the decrease in endorphin secretion during the luteal phase of the menstrual cycle and has a positive impact on PMS symptoms, particularly mood disorders, fluid retention, and breast tenderness. Pilates-based exercise training is an approach that enhances muscle stability through effective, controlled movements while strengthening muscle groups associated with pain. Clinical Pilates-based exercise training is considered a preferable method for PMS management, as it is believed to improve functional capacity, pain management, mood disorders, endurance, flexibility, symptom severity, and fear of movement in individuals with PMS. Due to the limited number of studies in the literature on PMS, our study aims to investigate the effects of a clinical Pilates-based exercise program on functional fitness parameters, symptom severity, and kinesiophobia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Pilates Group | Experimental | Behavioral: Recommendations for Enhancing General Well-Being, Other: Clinical Pilates |
| Control Group | Active comparator | Behavioral: Recommendations for Enhancing General Well-Being |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Having Premenstrual Syndrome (PMS)
- Being able to read and understand Turkish
- Willingness to participate in the study
Key exclusion criteria (4 listed)
- Being in menopause or perimenopause
- Being pregnant
- Currently participating in or having engaged in a regular exercise program (other than clinical Pilates) within the past year
- Having comorbid orthopedic, musculoskeletal, psychological, or cardiovascular conditions that may affect test evaluations
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 |
|---|---|---|
| Recommendations for Enhancing General Well-Being* Wear comfortable clothing and lie on your back. Place one hand on your abdomen. As you inhale through your nose, direct your breath towards your hand, and exhale through your mouth. * In the same position, place one hand on your abdomen, inhale through your nose, and expand your belly under your hand. As you exhale through your mouth, purse your lips and blow out the air from your lungs. * Engage in brisk walking at least three times a week. * Perform stretching exercises similar to yoga; try forward bends while standing and sitting. * Stay active throughout the month; you can dance, swim, or ride a bike. * Reduce your intake of tea and caffeine. * Increase your consumption of milk. * Drink plenty of water. * Reduce your intake of sugar-rich snacks such as chocolate. * Prioritize foods rich in calcium, as well as vitamins A, B, and E. | Behavioural | Clinical Pilates Group, Control Group |
| Clinical PilatesIn addition to the general well-being recommendations, the Clinical Pilates Group participated in a total of 16 face-to-face, clinically based Pilates exercise training sessions over eight weeks, with two sessions per week, each lasting 50 minutes. The exercise training started at the end of the menstrual cycle. The clinical Pilates-based exercise program applied to the group was designed by the researcher. The number of repetitions, levels, and variations of the exercises were progressively adjusted by the researcher according to the participants' conditions. During the first session, the principles of clinical Pilates were explained, following the BASI Pilates method as described by Isacowitz. Participants were taught alignment, breathing, and core engagement techniques. | Other | Clinical Pilates Group |
Primary outcome
Body Composition (Waist Circumference)
Time frame: 8 weeks
-Waist Circumference: Measured in centimeters using a non-elastic measuring tape at the narrowest point between the lowest rib and the anterior superior iliac spine (ASIS). It was recorded in centimeters.
Body Composition (Hip Circumference)
Time frame: 8 weeks
-Hip Circumference: Measured in centimeters at the widest part of the gluteus maximus and at the level of the pubis using a measuring tape.
Body Composition (Waist-to-Hip Ratio)
Time frame: 8 weeks
It is calculated by dividing the circumference of the waist by the circumference of the hips.
Functional Capacity
Time frame: 8 weeks
To analyze the participants' functional capacity, the 6-Minute Walk Test (6MWT) was conducted in accordance with the American Thoracic Society (ATS) criteria. In this test, participants were instructed to walk at their own pace without running for six minutes along a 30-meter straight corridor. Standardized encouragement phrases were used throughout the test to maintain motivation. The test result was recorded as the total distance walked in meters.
Flexibility
Time frame: 8 weeks
The Sit and Reach Test is a simple and widely used test to measure the flexibility. For the measurement, a test bench was used with the following dimensions: 32 cm in height, 35 cm in length, and 45 cm in width. A 0-50 cm measurement ruler was placed on the upper surface of the bench, extending 15 cm beyond the edge where the participants' feet were positioned. Participants were seated on the floor with their bare feet extended straight towards the test bench. The measurement was taken at the farthest point reached, where they held the position for 2 seconds. Measure the distance reached in centimeters.
Endurance (Trunk Flexion Test)
Time frame: 8 weeks
The Trunk Flexion Endurance Test measures core muscle endurance, especially in the abdominals and lower back. The person sits with knees bent, leans back to 60 degrees, and holds the position as long as possible. The test stops when the person loses form or falls backward and records in seconds.
Endurance (Lateral Bridge Test)
Time frame: 8 weeks
The Lateral Bridge Test measures core and lateral trunk muscle endurance, especially the obliques. The person holds a side plank position with the body straight and hips lifted. The test ends when the hips drop or the person loses form and records in seconds..
Endurance (Modified Biering-Sorensen Test)
Time frame: 8 weeks
The Modified Biering-Sorensen Test measures endurance of the lower back extensor muscles. The person lies prone on a bench, with the upper body unsupported beyond the edge and legs secured. They hold a horizontal position for as long as possible. The test stops when the person can no longer maintain the position and records in seconds.
Endurance (Prone Bridge Test)
Time frame: 8 weeks
The Prone Bridge Test (Plank Endurance Test) measures core stability and endurance, focusing on the abdominals, lower back, and shoulders. The person holds a forearm plank position, keeping the body straight and avoiding sagging or lifting the hips. The test ends when the person can no longer maintain proper form and records in seconds.
Premenstrual Syndrome Scale
Time frame: 8 weeks
The Premenstrual Syndrome Scale consists of 44 questions and is a five-point Likert-type assessment tool with the following response options: 1. - Never 2. - Very little 3. - Sometimes 4. - Often 5. - Always During the administration of the Premenstrual Syndrome Scale, participants were instructed to evaluate each item according to the period one week before menstruation, following the guidelines at the beginning of the scale. They were asked to mark the corresponding rating for each statement based on their experiences during this period.
Tampa Scale for Kinesiophobia
Time frame: 8 weeks
The Tampa Scale for Kinesiophobia is a 17-item questionnaire designed to measure the fear of movement and re-injury. It uses a 4-point Likert scale, with the following response options: 1. - Strongly disagree 2. - Disagree 3. - Agree 4. - Strongly agree A higher score on the scale indicates a greater level of kinesiophobia (fear of movement and re-injury).
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 19 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Meltem Kaya principal investigator
Atlas University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recommendations for Enhancing General Well-Being and Clinical Pilates in people with Premenstrual Syndrome and Pilates Exercise, run by Atlas University at 2 sites 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 3 inclusion and 4 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 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Body Composition (Waist Circumference) (time frame: 8 weeks). The study lists 11 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 19 Feb 2025.