NCT06774521

Brief Summary

The aim of this study is to investigate the effectiveness of Pilates exercises in the treatment of dysmenorrhea and to contribute to the literature and information on this subject.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2025

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

January 8, 2025

Last Update Submit

November 14, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Visual Analogue Scale

    Participants were included in the "healthy" category when they marked the 0-1 range of the scale, and were included in the "Menstruation pain" category when they marked the 1.1-10 range. They were divided into 3 groups according to pain severity. 1.1-3: Mild pain, 3.1-7: Moderate pain, 7.1-10: Severe pain.

    14 weeks

  • Menstruation Symptom Scale

    It is a 5-point Likert-type scale and consists of three sub-parameters: 'negative effects/somatic effects', 'menstrual pain' and 'coping methods', and 22 items. The person is asked to give a score between '1' never and '5' always for the symptoms they experience related to menstruation. The Menstruation Symptom Scale (MSS) score is calculated by taking the total score average. An increase in the mean score indicates an increase in the severity of menstrual symptoms.

    14 weeks

  • Fatigue Severity Scale

    It consists of 9 questions. Each question is scored between 1 and 7. Statements Regarding Scoring 1. I strongly disagree 3. I tend to disagree 5. I tend to agree 2. I disagree 4. I am undecided 6. I agree 7. I strongly agree. ) the score of the answers given to the question is added and divided by 9. If the result is less than 2.8, it is evaluated as "no fatigue". If the result is greater than 6.1, it is considered as "chronic fatigue syndrome

    14 weeks

  • Pittsburgh Sleep Quality Index

    It was developed by Buysse et al. (1989) (34). The scale is a safe and consistent questionnaire that evaluates the amount of sleep, sleep quality, presence and severity of sleep disorders in individuals in the last month. It was adapted into Turkish by Ağargün et al. (1996) (35). There are seven components in Pittsburg Sleep Quality Index. These components are subjective sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), sleep medication use (component 6) and daytime dysfunction. (component 7). The evaluation score of each item is between 0-3. The total score obtained varies between 0-21. The higher the score, the worse the sleep quality.

    14 weeks

Study Arms (3)

control group

ACTIVE COMPARATOR

those who did not receive any intervention

Other: control

reformer exercise group

EXPERIMENTAL

They will practice reformer pilates exercises

Other: reformer

mat exercise group

EXPERIMENTAL

They will practice mat pilates exercises

Other: mat

Interventions

controlOTHER

There is no intervention

control group

Reformer exercises: Foodwork Swan Short Spin Long Stretch Keen Stretch Hug Tree Bridge Pulling Straps Short Box Abdominal Hundred Twist Star

reformer exercise group
matOTHER

Mat exercises: Neck exercises Trunk stabilization exercises Shoulder exercises Posture exercises

mat exercise group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female individuals between the ages of 18-50
  • Those with a menstrual period of 3-9 days
  • Having menstrual pain complaints in most of their menstrual cycles
  • Cooperating in completing the assessment scales

You may not qualify if:

  • Having a history of abdominal surgery
  • Having an active infection
  • Having knee pain
  • Using medication
  • Participants with any pathology that prevents exercise will not be included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fizyorapt

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Ozeren A, Ulug N, Sahan N, Can Karahan Z. Does reformer pilates exercise improve cognitive functions in sedentary women? A randomized controlled study. J Bodyw Mov Ther. 2024 Oct;40:1899-1905. doi: 10.1016/j.jbmt.2024.10.031. Epub 2024 Oct 18.

    PMID: 39593541BACKGROUND
  • Aykut S, Sevgin O. Effect of video-based exercise on premenstrual symptoms: a randomized controlled trial. Ginekol Pol. 2025;96(2):102-108. doi: 10.5603/gpl.98199. Epub 2024 Oct 29.

    PMID: 39469819BACKGROUND
  • Peinado AB, Alfaro-Magallanes VM, Romero-Parra N, Barba-Moreno L, Rael B, Maestre-Cascales C, Rojo-Tirado MA, Castro EA, Benito PJ, Ortega-Santos CP, Santiago E, Butragueno J, Garcia-de-Alcaraz A, Rojo JJ, Calderon FJ, Garcia-Bataller A, Cupeiro R. Methodological Approach of the Iron and Muscular Damage: Female Metabolism and Menstrual Cycle during Exercise Project (IronFEMME Study). Int J Environ Res Public Health. 2021 Jan 16;18(2):735. doi: 10.3390/ijerph18020735.

    PMID: 33561085BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Methionine Adenosyltransferase

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Alkyl and Aryl TransferasesTransferasesEnzymesEnzymes and Coenzymes

Study Officials

  • Sümeyye Postacı

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 14, 2025

Study Start

January 15, 2025

Primary Completion

April 20, 2025

Study Completion

June 10, 2025

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations