Dysmenorrhea PrimaryNCT06750393
Combined Effects of Barre and Gym Ball Exercises in Primary Dysmenorhoea
A study testing Barre exercise along with gym ball exercises and Barre exercises in people with Dysmenorrhea Primary, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Barre exercise along with gym ball exercises and Barre exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Sialkot, University of Management Technology
Sialkot, Pjunjab, 51310
About this study
Official title: Combined Effects of Barre and Gym Ball Exercises on Pain, Distress and Quality of Life in Primary Dysmenorrhoea
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.
Read the detailed description
This will be a randomized controlled trial conducted on 42 participants. Data will be collected from USKT (University of Sialkot) and UMT (University of Management and Technology Sialkot by using non-probability convenience sampling technique. WaLLiD score scale is used to determine the severity of dysmenorrhoea. Girls between the age of 17 to 25 with history of dysmenorrhea will be included in this study. Participants who has history of secondary dysmenorrhea, Diagnosed with polycystic ovarian syndrome will be excluded from this study. A sample of 42 will be divided in to two groups with 21 participants in each group. 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. Pre and post assessment of pain, distress , severity of dysmenorrhoea and quality of life will be done by using numeric pain rating scale, menstrual distress questionnaire, WaLLiD scale and Q-LES-Q-SF questionnaire. Data will be analyzed by using SPSS version 26.0.
- Conditions
- Dysmenorrhea Primary
- Being tested
- Barre exercise along with gym ball exercises, Barre exercises
- Keywords
- gym, exercises, quality of life, dysmenorrhea, Menstrual Cycle, female
- Medical subject headings
- Motor Activity, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barre exercise along with gym ball exercisesOther
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 exercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Barre exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Aug 2024
- Primary completion1 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hina gul, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750393
- Sponsor's protocol ID
- REC/RCR&AHS/24/0528
- Status last verified
- Feb 2026
- First submitted
- 20 Dec 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
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.
PubMed 34360122.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 at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Barre and Gym Ball Exercises on Pain, Distress and Quality of Life in Primary Dysmenorrhoea
- ClinicalTrials.gov ID
- NCT06750393
- Acronym / sponsor ID
- REC/RCR&AHS/24/0528
- Conditions
- Dysmenorrhea Primary
- Keywords
- gym, exercises, quality of life, dysmenorrhea, Menstrual Cycle, female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a randomized controlled trial conducted on 42 participants. Data will be collected from USKT (University of Sialkot) and UMT (University of Management and Technology Sialkot by using non-probability convenience sampling technique. WaLLiD score scale is used to determine the severity of dysmenorrhoea. Girls between the age of 17 to 25 with history of dysmenorrhea will be included in this study. Participants who has history of secondary dysmenorrhea, Diagnosed with polycystic ovarian syndrome will be excluded from this study. A sample of 42 will be divided in to two groups with 21 participants in each group. 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. Pre and post assessment of pain, distress , severity of dysmenorrhoea and quality of life will be done by using numeric pain rating scale, menstrual distress questionnaire, WaLLiD scale and Q-LES-Q-SF questionnaire. Data will be analyzed by using SPSS version 26.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barre exercise with gym ball exercise | Experimental | Other: Barre exercise along with gym ball exercisesThe 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 |
| Barre exercises | Active comparator | Other: Barre exercisesThe 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 |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Females using hormonal contraception.
- Females who are married.
- Females with secondary dysmenorrhea
- Females diagnosed with polycystic ovarian syndrome
- Females having menstrual issues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barre exercise along with gym ball exercisesThe 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 | Other | Barre exercise with gym ball exercise |
| Barre exercisesThe 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 |
Primary outcome
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- BackgroundSamperio MM, Pardo ACJMSR. Efectos del ejercicio físico en la dismenorrea primaria. Revisión sistemática. 2021;1(1).
- BackgroundAzabu 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: PubMed 34360122Lopez-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.
- Background.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
- BackgroundHidayah N, Fatmawati R. The effectiveness of Gym Ball and ambon banana consumption against menstrual pain reduction in teenagers. 2022.
- BackgroundHemalatha 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.
- BackgroundTianing 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.
- BackgroundAli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hina gul, MSOMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barre exercise along with gym ball exercises and Barre exercises in people with Dysmenorrhea Primary, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain rating Scale (time frame: 12th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06750393, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.