- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06835062
Clinical Pilates' Impact on Fitness, Symptoms & Kinesiophobia in PMS
The Effects of Clinical Pilates on Physical Fitness Parameters, Symptom Severity, and Kinesiophobia in Women With Premenstrual Syndrome.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey
- Istanbul Atlas University
-
Istanbul, Turkey
- Atlas University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having Premenstrual Syndrome (PMS)
- Being able to read and understand Turkish
- Willingness to participate in the study
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
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Experimental: Clinical Pilates Group
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
8 weeks
|
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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.
|
8 weeks
|
|
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.
|
8 weeks
|
|
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. |
8 weeks
|
|
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.
|
8 weeks
|
|
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.
|
8 weeks
|
|
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..
|
8 weeks
|
|
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.
|
8 weeks
|
|
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.
|
8 weeks
|
|
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:
|
8 weeks
|
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Tampa Scale for Kinesiophobia
Time Frame: 8 weeks
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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:
A higher score on the scale indicates a greater level of kinesiophobia (fear of movement and re-injury). |
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Meltem Kaya, Atlas University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AtlasUmkaya04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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