Dysmenorrhea PrimaryNCT06500520
Resistive Exercise and Stretching in Women With Dysmenorrhea
A study testing Resisted Exercise group and Stretching Exercise group in people with Dysmenorrhea Primary, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
This study highlights the importance of exercise for young women with primary dysmenorrhea. Exercise can help relieve the symptoms of dysmenorrhea by increasing blood flow and promoting the release of endorphins. Additionally, exercise can improve the overall quality of life by reducing stress and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Resisted Exercise group and Stretching Exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 10 Feb 2024
- 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 18 to 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Having a score of 60 points or above on the menstrual symptoms scale
- Having a regular menstrual cycle (24-35 days)
- Not doing any exercise regularly
- Being between the ages of 18 and 25
- Nulliparity
- Being cooperative and oriented
- Volunteering to participate in the study
Who cannot join
- Having a medical history of chronic disease (cardiopulmonary, neurological, thyroid gland diseases)
- Having a history of regular exercise
- Engaging in regular sexual activity
- Having undergone gynecological surgical procedures
- Using hormonal contraceptive drugs or intrauterine devices
- Using a drug that causes dysmenorrhea
Show all 9Show fewer
- Pelvic pathology, pelvic inflammatory diseases, endometriosis, etc. Having a disease that causes secondary dysmenorrhea
- Using antidepressant medication
- Having acute musculoskeletal system problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Resistant Exercise and Stretching Exercises on Menstrual Symptoms, Quality of Life, Functional and Emotional Status in Young Women With Primary Dysmenorrhea
This study highlights the importance of exercise for young women with primary dysmenorrhea. Exercise can help relieve the symptoms of dysmenorrhea by increasing blood flow and promoting the release of endorphins. Additionally, exercise can improve the overall quality of life by reducing stress and anxiety. A comprehensive comparison of the effects of especially resistant exercises and stretching exercises on menstrual pain is based on limited findings in the literature. Therefore, this study aims to make a significant contribution to clinical practice by evaluating the effectiveness and feasibility of these exercise types.
Read the detailed description
Primary dysmenorrhea is a common condition that seriously affects women's quality of life, and alternative methods other than pharmacotherapy are often investigated. Exercise may play a potential role in reducing the symptoms of dysmenorrhea by increasing blood flow and promoting the release of endorphins. Additionally, exercise can improve the overall quality of life by reducing stress and anxiety. However, studies comparing the specific effects of resistance exercises and stretching exercises on dysmenorrhea are limited and do not provide clear guidance on this subject. The aim of this study is to evaluate the effectiveness and feasibility of these two types of exercise in young women with primary dysmenorrhea. The results of the research can guide healthcare professionals by providing information on which type of exercise may be more effective in clinical practice. The importance of exercise as a non-pharmacological treatment option is emphasized, and it is aimed at making a significant contribution to the wide acceptance and application of such treatments.
- Conditions
- Dysmenorrhea Primary
- Being tested
- Resisted Exercise group, Stretching Exercise group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resisted Exercise groupOther
The resisted exercise training program targeted trunk, upper, and lower body segments with 10-12 repetitions at 30-65% intensity, lasting 50-60 minutes per session, 3 times weekly for 8 weeks. Participants determined their maximal repetition through trial training. Maximal power was assessed using concentric 1-maximal repetition (MT). Following a 2-3 minute rest and a 5-minute warm-up (walking), participants performed the 1-MT test to establish their heaviest lift with the correct technique, adjusting resistance levels accordingly. The circuit-style training spanned 9 stations with 2-3 sets per station, each circuit lasting 2-3 minutes with 90-second rests between sets. A 5-minute warm-up and cool-down (walking) preceded and followed each session. Exercises included bilateral elbow flexion, chest press, bilateral shoulder abduction, bilateral knee extension, back extension, sit-ups, knee flexion, hip abduction, and hip adduction.
Stretching Exercise groupOther
The participants were made to perform stretching exercises, selected by reviewing the literature, under supervision 3 days a week for 8 weeks, and they were asked not to do any other exercises during this intervention period. They were asked to do exercises such as trunk flexion, pelvic elevation, squatting, trunk lateral flexion, lumbar extensor stretching, lower abdominal stretching, hip adduct stretching, piriformis stretching, and trunk flexor stretching (cobra pose). The holding time was 5 seconds, the rest time was 1 second, and the exercises were applied in 10 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Resisted Exercise group | Active comparator | Participants underwent resistance training for 8 weeks, focusing on trunk, upper, and lower body segments with 10-12 reps per exercise at 30-65% intensity. Sessions lasted 50-60 minutes, 3 times weekly Receives: Other: Resisted Exercise group |
| Stretching Exercise group | Active comparator | The participants were made to perform stretching exercises, selected by reviewing the literature, under supervision 3 days a week for 8 weeks, and they were asked not to do any other exercises during this intervention period. Receives: Other: Stretching Exercise group |
| control group | No intervention | No treatment was applied to the control group; they were allowed to use painkillers and continued their normal daily lives. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Lower abdomen, leg and low back pain were evaluated with the Visual Analog Scale
Measured: At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
Menstrual symptoms questionnaire
menstrual symptoms were evaluated with the Menstrual Symptoms Questionnaire
Measured: At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
Pittsburgh Sleep Quality Index
sleep quality was evaluated with the Pittsburgh Sleep Quality Index
Measured: At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
Health-Related Quality of Life Assessment (SF 36 Short Form)
Quality of life was evaluated with the Health-Related Quality of Life Assessment (SF 36 Short Form)
Measured: At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
Functional and Emotional Dysmenorrhea Questionnaire
functional and emotional status was evaluated with the Functional and Emotional Dysmenorrhea Questionnaire
Measured: At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Dec 2023
- Primary completion10 Feb 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, METEHAN YANA, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500520
- Sponsor's protocol ID
- women Health
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moradpour, R., "Resistance training improves primary dysmenorrhea symptoms in young girls: A randomized controlled trial", Journal of Physical Activity and Hormones, 3(3): 35-48 (2019).
Brown J, Brown S. Exercise for dysmenorrhoea. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD004142. doi: 10.1002/14651858.CD004142.pub2.
PubMed 20166071Carroquino-Garcia P, Jimenez-Rejano JJ, Medrano-Sanchez E, de la Casa-Almeida M, Diaz-Mohedo E, Suarez-Serrano C. Therapeutic Exercise in the Treatment of Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Phys Ther. 2019 Oct 28;99(10):1371-1380. doi: 10.1093/ptj/pzz101.
PubMed 31665789Motahari-Tabari N, Shirvani MA, Alipour A. Comparison of the Effect of Stretching Exercises and Mefenamic Acid on the Reduction of Pain and Menstruation Characteristics in Primary Dysmenorrhea: A Randomized Clinical Trial. Oman Med J. 2017 Jan;32(1):47-53. doi: 10.5001/omj.2017.09.
PubMed 28042403
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Resistant Exercise and Stretching Exercises on Menstrual Symptoms, Quality of Life, Functional and Emotional Status in Young Women With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06500520
- Acronym / sponsor ID
- women Health
- Conditions
- Dysmenorrhea Primary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 15 Jul 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.
This study highlights the importance of exercise for young women with primary dysmenorrhea. Exercise can help relieve the symptoms of dysmenorrhea by increasing blood flow and promoting the release of endorphins. Additionally, exercise can improve the overall quality of life by reducing stress and anxiety. A comprehensive comparison of the effects of especially resistant exercises and stretching exercises on menstrual pain is based on limited findings in the literature. Therefore, this study aims to make a significant contribution to clinical practice by evaluating the effectiveness and feasibility of these exercise types.
Detailed description
Primary dysmenorrhea is a common condition that seriously affects women's quality of life, and alternative methods other than pharmacotherapy are often investigated. Exercise may play a potential role in reducing the symptoms of dysmenorrhea by increasing blood flow and promoting the release of endorphins. Additionally, exercise can improve the overall quality of life by reducing stress and anxiety. However, studies comparing the specific effects of resistance exercises and stretching exercises on dysmenorrhea are limited and do not provide clear guidance on this subject. The aim of this study is to evaluate the effectiveness and feasibility of these two types of exercise in young women with primary dysmenorrhea. The results of the research can guide healthcare professionals by providing information on which type of exercise may be more effective in clinical practice. The importance of exercise as a non-pharmacological treatment option is emphasized, and it is aimed at making a significant contribution to the wide acceptance and application of such treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resisted Exercise group | Active comparator | Other: Resisted Exercise groupParticipants underwent resistance training for 8 weeks, focusing on trunk, upper, and lower body segments with 10-12 reps per exercise at 30-65% intensity. Sessions lasted 50-60 minutes, 3 times weekly |
| Stretching Exercise group | Active comparator | Other: Stretching Exercise groupThe participants were made to perform stretching exercises, selected by reviewing the literature, under supervision 3 days a week for 8 weeks, and they were asked not to do any other exercises during this intervention period. |
| control group | No intervention | –No treatment was applied to the control group; they were allowed to use painkillers and continued their normal daily lives. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Having a score of 60 points or above on the menstrual symptoms scale
- Having a regular menstrual cycle (24-35 days)
- Not doing any exercise regularly
- Being between the ages of 18 and 25
- Nulliparity
Key exclusion criteria (9 listed)
- Having a medical history of chronic disease (cardiopulmonary, neurological, thyroid gland diseases)
- Having a history of regular exercise
- Engaging in regular sexual activity
- Having undergone gynecological surgical procedures
- Using hormonal contraceptive drugs or intrauterine devices
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 |
|---|---|---|
| Resisted Exercise groupThe resisted exercise training program targeted trunk, upper, and lower body segments with 10-12 repetitions at 30-65% intensity, lasting 50-60 minutes per session, 3 times weekly for 8 weeks. Participants determined their maximal repetition through trial training. Maximal power was assessed using concentric 1-maximal repetition (MT). Following a 2-3 minute rest and a 5-minute warm-up (walking), participants performed the 1-MT test to establish their heaviest lift with the correct technique, adjusting resistance levels accordingly. The circuit-style training spanned 9 stations with 2-3 sets per station, each circuit lasting 2-3 minutes with 90-second rests between sets. A 5-minute warm-up and cool-down (walking) preceded and followed each session. Exercises included bilateral elbow flexion, chest press, bilateral shoulder abduction, bilateral knee extension, back extension, sit-ups, knee flexion, hip abduction, and hip adduction. | Other | Resisted Exercise group |
| Stretching Exercise groupThe participants were made to perform stretching exercises, selected by reviewing the literature, under supervision 3 days a week for 8 weeks, and they were asked not to do any other exercises during this intervention period. They were asked to do exercises such as trunk flexion, pelvic elevation, squatting, trunk lateral flexion, lumbar extensor stretching, lower abdominal stretching, hip adduct stretching, piriformis stretching, and trunk flexor stretching (cobra pose). The holding time was 5 seconds, the rest time was 1 second, and the exercises were applied in 10 repetitions. | Other | Stretching Exercise group |
Primary outcome
Visual Analog Scale
Time frame: At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
Lower abdomen, leg and low back pain were evaluated with the Visual Analog Scale
Menstrual symptoms questionnaire
Time frame: At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
menstrual symptoms were evaluated with the Menstrual Symptoms Questionnaire
Pittsburgh Sleep Quality Index
Time frame: At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
sleep quality was evaluated with the Pittsburgh Sleep Quality Index
Health-Related Quality of Life Assessment (SF 36 Short Form)
Time frame: At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
Quality of life was evaluated with the Health-Related Quality of Life Assessment (SF 36 Short Form)
Functional and Emotional Dysmenorrhea Questionnaire
Time frame: At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).
functional and emotional status was evaluated with the Functional and Emotional Dysmenorrhea Questionnaire
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 15 Jul 2024.
- BackgroundMoradpour, R., "Resistance training improves primary dysmenorrhea symptoms in young girls: A randomized controlled trial", Journal of Physical Activity and Hormones, 3(3): 35-48 (2019).
- Background: PubMed 20166071Brown J, Brown S. Exercise for dysmenorrhoea. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD004142. doi: 10.1002/14651858.CD004142.pub2.
- Background: PubMed 31665789Carroquino-Garcia P, Jimenez-Rejano JJ, Medrano-Sanchez E, de la Casa-Almeida M, Diaz-Mohedo E, Suarez-Serrano C. Therapeutic Exercise in the Treatment of Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Phys Ther. 2019 Oct 28;99(10):1371-1380. doi: 10.1093/ptj/pzz101.
- Background: PubMed 28042403Motahari-Tabari N, Shirvani MA, Alipour A. Comparison of the Effect of Stretching Exercises and Mefenamic Acid on the Reduction of Pain and Menstruation Characteristics in Primary Dysmenorrhea: A Randomized Clinical Trial. Oman Med J. 2017 Jan;32(1):47-53. doi: 10.5001/omj.2017.09.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resisted Exercise group and Stretching Exercise group in people with Dysmenorrhea Primary, run by Karabuk University at 1 site in Turkey (Türkiye).
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 7 inclusion and 9 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 15 Jul 2024. 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 Turkey (Türkiye). 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?
Visual Analog Scale (time frame: At baseline, on the most painful 1 day of Cycle 1 (each cycle is 28 days), and on the most painful 1 day of Cycle 2 (each cycle is 28 days).). The study lists 5 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 NCT06500520, which also lists 4 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 15 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.