NCT07335926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 2, 2026

Last Update Submit

January 12, 2026

Conditions

Keywords

tele-pilatesmenstrual painmuscle endurance

Outcome Measures

Primary Outcomes (1)

  • Menstrual pain severity

    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 Outcomes (6)

  • Menstrual symptom severity (Menstrual Symptom Questionnaire total score)

    Change from baseline to post-intervention (8 weeks)

  • Functional and emotional burden (Functional and Emotional Measure of Dysmenorrhea total score)

    Change from baseline to post-intervention (8 weeks)

  • Trunk muscle endurance (McGill tests: flexor muscles)

    Change from baseline to post-intervention (8 weeks)

  • Trunk muscle endurance (McGill tests: extensor muscles)

    Change from baseline to post-intervention (8 weeks)

  • Trunk muscle endurance (McGill tests: lateral flexor muscles)

    Change from baseline to post-intervention (8 weeks)

  • +1 more secondary outcomes

Study Arms (2)

Tele-Pilates Group

EXPERIMENTAL

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.

Other: Tele-Pilates Exercise programBehavioral: standardized menstrual health education online

Control Group

ACTIVE COMPARATOR

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

Behavioral: standardized menstrual health education online

Interventions

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.

Tele-Pilates Group

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 GroupTele-Pilates Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligibility is limited to individuals who self-identify as women, as primary dysmenorrhea is a condition specific to those with a female reproductive system.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-35 years
  • Regular menstrual cycles (28±7 days)
  • VAS ≥5 for menstrual pain
  • Diagnosed with primary dysmenorrhea

You may not qualify if:

  • Secondary dysmenorrhea (e.g., endometriosis, fibroids)
  • Pregnancy or use of intrauterine devices
  • Significant comorbidities (e.g., spondylolisthesis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlas University

Istanbul, Kağıthane, 34413, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Hilal DENİZOĞLU KÜLLİ

    İSTANBUL ATLAS ÜNİVERSİTESİ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 13, 2026

Study Start

April 1, 2024

Primary Completion

June 15, 2024

Study Completion

July 1, 2024

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

No plan to share individual participant data (IPD).

Locations