NCT05998044

Brief Summary

The aim of this study is to examine the effects of Pilates Based Exercises on premenstrual symptom (PMS) symptoms, perceived stress level and pain intensity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

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

Study Start

First participant enrolled

August 1, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2023

Completed
Last Updated

October 13, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

August 9, 2023

Last Update Submit

October 12, 2023

Conditions

Keywords

stressPilates Based Exercises

Outcome Measures

Primary Outcomes (3)

  • Premenstrual Syndrome Scale (PMSS)

    PMSS is a 44-item five-point Likert-type scale (Never, Rarely, Sometimes, Often, and Continuous). As stated in the instruction at the beginning of the scale, after the item is read, marking is made by taking into account the scale on the right of the relevant item, according to the "being in the period one week before the period". In scoring the scale, "Never" option is evaluated as 1 point, "Very little" option as 2 points, "Sometimes" option as 3 points, "Often" option as 4 points and "Constantly" option as 5 points. the high score is 220. In addition, PMSS severity classes can be created according to the scores obtained from the scale. Accordingly, a score of 88 and above from the PMSS scale total indicates severe PMS symptoms, and a score below 88 indicates mild premenstrual syndrome symptoms.

    10 weeks

  • Perceived Stress Scale (PSS)

    The perceived stress scale consists of 14 five-point Likert type items. The scale consists of "never (0), almost never" (1), "sometimes" (2), "often" (3) "very often" (4). In this 14-item form, items 4-5-6-7-9-10 and 13 are scored in reverse. The lowest and highest scores that the participant can obtain from this scale are 0 and 56, respectively. A high total score means a high Perceived Stress Level Scale. It can be said that the participants, whose score range is between 0-35, are in a positive stress level, can effectively cope with stress, and the coping mechanisms they use are also functional. It can be said that the methods used by the participants with a score range of 36-56 to cope with stress are not functional, and therefore they cannot cope with stress effectively.

    10 weeks

  • McGill Melzack Pain Questionnaire (MPQ)

    MPQ consists of four parts. In the first part, the patient is asked to mark the location of the pain on the body chart and to indicate with the letter 'D' if the pain is deep and 'Y' on the body surface. In the second part, the patient is asked what he compares his pain to. There are 20 word groups with 2 to 6 descriptive words that describe pain in terms of sensory, perceptual and evaluation. The first 10 groups of words include the sensory dimension, the next 5 the perceptual dimension, the 16th group evaluation, and the last 4 groups of multifaceted words that indicate different aspects of pain. In the third part, the relationship of pain with time is asked. In addition, it is asked what reduces pain and what increases it. In the fourth chapter; The patient is asked questions to determine the severity of pain. Evaluation is made on a rating scale consisting of words describing the severity of pain.

    10 weeks

Study Arms (2)

control group

ACTIVE COMPARATOR

Before starting the study for the Control Group, the participants were informed about the research and their consent will be obtained. Afterwards, evaluation surveys will be applied. They will be asked not to participate in any regular exercise for 8 weeks. At the end of 8 weeks, re-evaluation surveys will be applied.

Other: control

pilates group

EXPERIMENTAL

After people fill out the evaluation questionnaires, they will watch the video recording of pilates based exercises via the link sent to them via Google Drive, and they will be applied twice a week for 8 weeks. All exercises in the video recording will be explained in written, applied and verbal form by the physiotherapist, and they will be asked to practice. Every week, feedback will be received from people that they have done the exercises via their contact numbers. The average application time of the exercises is 30-40 minutes (with the first 10 minutes of warming up and the last 5 minutes of stretching). Participants will be asked to open the video recording each time they exercise and follow them to do the exercises. At the end of 8 weeks, re-evaluation surveys will be applied.

Other: Pilates Based Exercises

Interventions

The average application time of the exercises is 30-40 minutes (with the first 10 minutes of warming up and the last 5 minutes of stretching). The first four exercises were used for the warm-up period and the last four exercises were used for the stretching period. The exercises will be done as 1 set of 8 repetitions. The Hundred exercise will be increased to 10 sets of 10 reps every two weeks to 10 reps, 12 reps, and 14 reps, respectively. Participants will be asked to open the video recording each time they exercise and follow them to do the exercises. Exercise Program: * Arm Circles * Toe Touch * bridge * Shoulder Bridge * Chest Lift * Hundred * Roll Up * Leg Circles * Chris Cross * Side Kick * Side Leg Circles * one leg kick * double leg kick * Swan * Single leg Stretch * Double leg Stretch * saw * Spine Stretch

pilates group
controlOTHER

They will be asked not to participate in any regular exercise for 8 weeks.

control group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPremenstrual syndrome is a female-specific disorder.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being a woman between the ages of 18-35.
  • Not having a condition that prevents exercise (not having orthopedic, cardiopulmonary, mental diseases, etc. that will prevent exercise).
  • Not having given birth.
  • Volunteer to participate in the study.
  • Having a score above the mild level on the PMSS score.
  • Normal menstrual cycle.

You may not qualify if:

  • Having a condition that prevents you from exercising.
  • Having a chronic disease.
  • Being on any medication regularly.
  • Being pregnant.
  • Being in the menopausal period.
  • Having a gynecological disease (endometriosis, ovarian cyst, pelvic infection, fibroid/uterine tumor etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Üsküdar Unıversıty

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • Dickerson LM, Mazyck PJ, Hunter MH. Premenstrual syndrome. Am Fam Physician. 2003 Apr 15;67(8):1743-52.

    PMID: 12725453BACKGROUND
  • Citil ET, Kaya N. Effect of pilates exercises on premenstrual syndrome symptoms: a quasi-experimental study. Complement Ther Med. 2021 Mar;57:102623. doi: 10.1016/j.ctim.2020.102623. Epub 2020 Nov 24.

    PMID: 33246104BACKGROUND
  • El-Lithy A, El-Mazny A, Sabbour A, El-Deeb A. Effect of aerobic exercise on premenstrual symptoms, haematological and hormonal parameters in young women. J Obstet Gynaecol. 2015 May;35(4):389-92. doi: 10.3109/01443615.2014.960823. Epub 2014 Oct 3.

    PMID: 25279689BACKGROUND
  • Di Lorenzo CE. Pilates: what is it? Should it be used in rehabilitation? Sports Health. 2011 Jul;3(4):352-61. doi: 10.1177/1941738111410285.

    PMID: 23016028BACKGROUND
  • Cruz-Ferreira A, Fernandes J, Laranjo L, Bernardo LM, Silva A. A systematic review of the effects of pilates method of exercise in healthy people. Arch Phys Med Rehabil. 2011 Dec;92(12):2071-81. doi: 10.1016/j.apmr.2011.06.018. Epub 2011 Oct 24.

    PMID: 22030232BACKGROUND

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Şeyma AYKUT

    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
Model Details: Pilates exercises will be given to the experimental group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 18, 2023

Study Start

August 1, 2023

Primary Completion

October 12, 2023

Study Completion

October 12, 2023

Last Updated

October 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations