NCT06750393

Brief Summary

Group A will be given Barre and gym ball exercises. Group B will be given Barre exercises. All these sessions will be of 30-minute 3session per week for 12 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

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, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

December 20, 2024

Last Update Submit

February 23, 2026

Conditions

Keywords

gymexercisesquality of lifedysmenorrheaMenstrual Cyclefemale

Outcome Measures

Primary Outcomes (4)

  • Numeric Pain rating Scale

    Numeric pain rating scale is a subjective measure 11 point numerical scale which is used to measure pain. Is scoring range In this scale 0 shows no pain and 10 shows worst pain imaginable. It has good reliability of 0.79 and validity of 0.96.

    12th week

  • Menstrual distress questionnaire (MEDI-Q):

    The Menstrual Distress Questionnaire (MEDI-Q) is a newly developed tool that has been validated for comprehensive evaluation of menstrual-related distress .It consists of 25 items that cover different areas of menstruation-related symptoms, such as pain, discomfort, psychic or cognitive changes, and gastrointestinal disturbances. In this scale 0 -16 score indicates Mild symptoms, indicating minimal distress,17-34 indicates Moderate symptoms, indicating moderate distress.35-56 indicates Severe symptoms. It is reliable tool with reliability 0.84 and validity 0.95.

    12th week

  • Quality Of Life Enjoyment And Satisfaction Questionnaire Short Form(Q-LESQ-SF)

    Short-Form (Q-LES-Q-SF) was derived from the general activities scale of the original 93- item questionnaire. It consists of 16 items but only 14 item scores are computed, the last two are stand-alone items. Q-LES-Q-SF is rated on a 5-point scale as 1-very poor, 2-poor, 3-fair, 4-good, and 5-very good. 70 is the maximum score. It is a reliable and valid tool with values 0.9 and 0.93.

    12th week

  • WaLLiD Score

    WaLLiD score was designed to diagnose dysmenorrhea and predict medical leave score as a standard survey that validated and constructed the classification of the severity of dysmenorrhea. The interpretation of the WaLLiD questionnaire is as follows: 0 = No dysmenorrhea 1-4 =Mild dysmenorrhea 5-7 = Moderate dysmenorrhea 8-12 = Severe dysmenorrhea WaLLiD score is reliable tool with value of 0.723

    12th week

Study Arms (2)

Barre exercise with gym ball exercise

EXPERIMENTAL

The Barre exercises will be administered to the participant of Group A for a period of 3 month. Each exercise will be given for 10 s hold × 12 times/set × 3 sets/day × 3 days/week × 12. Gym ball exercises program include Knee tucks, leg curls, back extension exercises

Other: Barre exercise along with gym ball exercises

Barre exercises

ACTIVE COMPARATOR

The Barre exercises for a period of 3 month Each exercise will be given for 10 s hold × 12 times/set × 3 sets/day × 3 days/week × 12. During

Other: Barre exercises

Interventions

The Barre exercises will be administer to the participant of Group A for a period of 3 month. Each exercise will be given for 10 s hold × 12 times/set × 3 sets/day × 3 days/week × 12. Gym ball exercises program include Knee tucks, leg curls, back extension exercises

Barre exercise with gym ball exercise

The Barre exercises for a period of 3 month Each exercise will be given for 10 s hold × 12 times/set × 3 sets/day × 3 days/week × 12. During

Barre exercises

Eligibility Criteria

Age17 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsdiagnosed with primary dysmenorrhea
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female suffered from primary dysmenorrhea diagnosed through WaLLiD score range from 5-12
  • Female having 5 and above score on Numerical Pain Rating Scale
  • Female having regular menstrual period form at least 3 months
  • Female having a history of dysmenorrhea occurring at least three times in the past six months

You may not qualify if:

  • Females using hormonal contraception.
  • Females who are married.
  • Females with secondary dysmenorrhea
  • Females diagnosed with polycystic ovarian syndrome
  • Females having menstrual issues
  • Females who take analgesic
  • Females having BMI \> 25
  • Participants who show unwillingness to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sialkot, University of Management Technology

Sialkot, Pjunjab, 51310, Pakistan

Location

Related Publications (8)

  • Samperio MM, Pardo ACJMSR. Efectos del ejercicio físico en la dismenorrea primaria. Revisión sistemática. 2021;1(1).

    BACKGROUND
  • Azabu A, Fernandes P, Thomas T. Effect Of a Gym Ball Exercise Program on Dysmenorrhea in Nursing Students of a Selected College in Mangaluru, India: A Quasi experimental Study. gums-hnmj. 2024;34(1):29-34

    BACKGROUND
  • Lopez-Liria R, Torres-Alamo L, Vega-Ramirez FA, Garcia-Luengo AV, Aguilar-Parra JM, Trigueros-Ramos R, Rocamora-Perez P. Efficacy of Physiotherapy Treatment in Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jul 23;18(15):7832. doi: 10.3390/ijerph18157832.

    PMID: 34360122BACKGROUND
  • .Krasova I, Semyzorova A, Deineko A, Beihul I, Shyshkina OJPR, Technologies RH. Barre fitness as a modern means of improving the health of women in the first period of adulthood. 2023;8(1):29-38

    BACKGROUND
  • Hidayah N, Fatmawati R. The effectiveness of Gym Ball and ambon banana consumption against menstrual pain reduction in teenagers. 2022.

    BACKGROUND
  • Hemalatha R, Shanmugananth E, Murugaraj T, Velkumar VJJoCLM. Effects of Barre Exercise Versus Pilates Versus Aerobic Exercise on Pre-Menstrual Syndrome Among College Going Coastal Students. 2023;11:2440-51.

    BACKGROUND
  • Tianing NW, Nugraha MHS, Indrayani AW, Widyadharma IPEJBMJ. The difference in the effectiveness of warm compress and active stretching exercise in reducing dysmenorrhea pain. 2021;10(3):1041-4.

    BACKGROUND
  • Ali Z, Cardoza J. A Study on Effects of Aerobic Exercises on Quality of Life in Primary Dysmenorrhea in Bangalore. Natural Volatiles and Essential Oils. 2021;8:5304-12.

    BACKGROUND

MeSH Terms

Conditions

Motor ActivityDysmenorrhea

Condition Hierarchy (Ancestors)

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

Study Officials

  • hina gul, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

December 20, 2024

First Posted

December 27, 2024

Study Start

August 1, 2024

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations