- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07335926
Tele-Pilates for Primary Dysmenorrhea
January 12, 2026 updated by: Hilal Denizoğlu Külli, Atlas University
Tele-Pilates for Primary Dysmenorrhea: A Randomized Controlled Trial on Pain, Symptoms, and Trunk Endurance
This randomized controlled trial investigates the effectiveness of a synchronized tele-Pilates program on menstrual pain, symptom severity, physical disability, and trunk muscle endurance in women with primary dysmenorrhea (PD).
The intervention includes 16 supervised online Pilates sessions delivered over eight weeks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Primary dysmenorrhea is a prevalent gynecological condition characterized by painful menstruation.
Exercise, particularly core stabilization and mind-body methods like Pilates, may improve both physical and psychological symptoms associated with PD.
In this single-center RCT, 34 women aged 18-35 with PD were randomized to either a Tele-Pilates group or a control group.
The Pilates group received supervised online sessions twice weekly for 8 weeks.
Outcomes included pain severity (VAS), symptom burden (MSQ), functional impairment (FEMD), disability (Oswestry LBP Index), and trunk muscle endurance (McGill tests).
Findings demonstrated significant improvements in the Pilates group across all domains.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kağıthane
-
Istanbul, Kağıthane, Turkey (Türkiye), 34413
- Atlas University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Women aged 18-35 years
- Regular menstrual cycles (28±7 days)
- VAS ≥5 for menstrual pain
- Diagnosed with primary dysmenorrhea
Exclusion Criteria:
- Secondary dysmenorrhea (e.g., endometriosis, fibroids)
- Pregnancy or use of intrauterine devices
- Significant comorbidities (e.g., spondylolisthesis)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tele-Pilates Group
Participants received 16 synchronous tele-Pilates sessions over 8 weeks (twice per week).
Exercises followed the APPI method including stretching, core strengthening, pelvic floor training, and breathing-focused control.
|
The intervention consisted of a synchronous, supervised tele-Pilates exercise program delivered via video conferencing platforms twice per week for 8 weeks.
Each session lasted approximately 50 minutes and followed clinical Pilates principles based on the APPI method.
The program emphasized core activation, diaphragmatic breathing, pelvic alignment, and trunk stabilization through progressively structured movements.
Real-time feedback from a physiotherapist ensured correct execution, adaptation to individual capacity, and consistent adherence.
The exercise protocol also incorporated components such as pelvic floor activation, transversus abdominis training, and guided relaxation.
The education module consisted of two 45-minute interactive sessions conducted by a physiotherapist and covered the physiology of the menstrual cycle, pathophysiology of primary dysmenorrhea, common symptoms, and non-pharmacological management strategies.
Content also included lifestyle modifications such as hydration, nutrition, physical activity, stress reduction techniques, and proper menstrual hygiene practices.
Educational materials were adapted from current evidence-based guidelines and delivered using digital slides and discussion-based formats to promote participant engagement and understanding.
|
|
Active Comparator: Control Group
Participants received standardized menstrual health education online but no exercise intervention.
|
The education module consisted of two 45-minute interactive sessions conducted by a physiotherapist and covered the physiology of the menstrual cycle, pathophysiology of primary dysmenorrhea, common symptoms, and non-pharmacological management strategies.
Content also included lifestyle modifications such as hydration, nutrition, physical activity, stress reduction techniques, and proper menstrual hygiene practices.
Educational materials were adapted from current evidence-based guidelines and delivered using digital slides and discussion-based formats to promote participant engagement and understanding.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Menstrual pain severity
Time Frame: Change from baseline to post-intervention (8 weeks)
|
Menstrual pain severity was assessed using a 10 cm Visual Analog Scale, where participants marked the most intense pain experienced during their last menstrual cycle.
|
Change from baseline to post-intervention (8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Menstrual symptom severity (Menstrual Symptom Questionnaire total score)
Time Frame: Change from baseline to post-intervention (8 weeks)
|
The Menstrual Symptom Questionnaire is a 24-item self-report measure assessing the severity of menstrual-related symptoms across emotional, physical, and pain domains; each item is rated on a 5-point Likert scale (1 = never to 5 = always), yielding a total score range of 24 to 120, where higher scores indicate worse symptom severity.
|
Change from baseline to post-intervention (8 weeks)
|
|
Functional and emotional burden (Functional and Emotional Measure of Dysmenorrhea total score)
Time Frame: Change from baseline to post-intervention (8 weeks)
|
Functional and Emotional Measure of Dysmenorrhea (FEMD) is a 14-item self-report scale assessing the functional and emotional impact of dysmenorrhea, with each item rated on a 5-point Likert scale (1 = not at all similar to my situation to 5 = very similar to my situation), yielding a total score range of 14 to 70, where higher scores indicate greater functional and emotional impairment.
|
Change from baseline to post-intervention (8 weeks)
|
|
Trunk muscle endurance (McGill tests: flexor muscles)
Time Frame: Change from baseline to post-intervention (8 weeks)
|
Endurance of trunk flexor muscles was measured using McGill's standardized core endurance test protocol, with duration recorded in seconds.
|
Change from baseline to post-intervention (8 weeks)
|
|
Trunk muscle endurance (McGill tests: extensor muscles)
Time Frame: Change from baseline to post-intervention (8 weeks)
|
Endurance of trunk extensor muscles was measured using McGill's standardized core endurance test protocol, with duration recorded in seconds.
|
Change from baseline to post-intervention (8 weeks)
|
|
Trunk muscle endurance (McGill tests: lateral flexor muscles)
Time Frame: Change from baseline to post-intervention (8 weeks)
|
Endurance of trunk lateral flexor muscles was measured using McGill's standardized core endurance test protocol, with duration recorded in seconds.
|
Change from baseline to post-intervention (8 weeks)
|
|
Disability due to low back pain (Oswestry Index)
Time Frame: Change from baseline to post-intervention (8 weeks)
|
The Oswestry Disability Index was used to measure functional disability related to low back pain, commonly accompanied by dysmenorrhea, a 10-item scale.
Each item is scored from 0 to 5, resulting in a total score range of 0 to 50, where higher scores indicate greater levels of disability and functional limitation.
|
Change from baseline to post-intervention (8 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hilal DENİZOĞLU KÜLLİ, İSTANBUL ATLAS ÜNİVERSİTESİ
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2024
Primary Completion (Actual)
June 15, 2024
Study Completion (Actual)
July 1, 2024
Study Registration Dates
First Submitted
January 2, 2026
First Submitted That Met QC Criteria
January 12, 2026
First Posted (Actual)
January 13, 2026
Study Record Updates
Last Update Posted (Actual)
January 13, 2026
Last Update Submitted That Met QC Criteria
January 12, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- hilalbuse1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan to share individual participant data (IPD).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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