Tele-Pilates for Primary Dysmenorrhea

NCT ID: NCT07335926

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2024-07-01

Brief Summary

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.

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.

Conditions

Primary Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tele-Pilates Exercise program

Intervention Type: OTHER

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.

standardized menstrual health education online

Intervention Type: BEHAVIORAL

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.

Control Group

Participants received standardized menstrual health education online but no exercise intervention.

Group Type: ACTIVE_COMPARATOR

standardized menstrual health education online

Intervention Type: BEHAVIORAL

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.

Interventions

Tele-Pilates Exercise program

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.

Intervention Type: OTHER

standardized menstrual health education online

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Atlas University

OTHER

Sponsor Role: lead

Responsible Party

Hilal Denizoğlu Külli

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hilal DENİZOĞLU KÜLLİ

Role: PRINCIPAL_INVESTIGATOR

İSTANBUL ATLAS ÜNİVERSİTESİ

Locations

Atlas University

Istanbul, Kağıthane, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

hilalbuse1

Identifier Type: -

Identifier Source: org_study_id