- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06750393
Combined Effects of Barre and Gym Ball Exercises in Primary Dysmenorhoea
Combined Effects of Barre and Gym Ball Exercises on Pain, Distress and Quality of Life in Primary Dysmenorrhoea
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pjunjab
-
Sialkot, Pjunjab, Pakistan, 51310
- University of Sialkot, University of Management Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Barre exercise with gym ball exercise
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 |
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 |
|
Active Comparator: Barre exercises
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 |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain rating Scale
Time Frame: 12th week
|
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):
Time Frame: 12th week
|
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)
Time Frame: 12th week
|
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
Time Frame: 12th week
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: hina gul, MSOMPT, Riphah International University
Publications and helpful links
General Publications
- 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.
- Samperio MM, Pardo ACJMSR. Efectos del ejercicio físico en la dismenorrea primaria. Revisión sistemática. 2021;1(1).
- 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
- .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
- Hidayah N, Fatmawati R. The effectiveness of Gym Ball and ambon banana consumption against menstrual pain reduction in teenagers. 2022.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/24/0528
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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