Primary DysmenorrheaNCT05243927
Comparison of Aerobic Exercise and Spinal Stabilization Exercises in Women With Primary Dysmenorrhea
A study testing Aerobic exercise program and Spinal stabilization exercise program in people with Primary Dysmenorrhea, run by Ankara Yildirim Beyazıt University.
Trial summary
The aim of the study is to compare the effects of aerobic exercise and spinal stabilization exercises in women with primary dysmenorrhea (PD) complaints. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Aerobic exercise program and Spinal stabilization exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Aug 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with primary dysmenorrhea complaint according to the Primary Dysmenorrhea Consensus Guide, Over 18 years of age, Having a mean pain intensity of moderate and higher according to the Visual Analogue Scale in the last 6 months, Having a regular menstrual cycle (28±7 days), Volunteered to participate in the study.
Who cannot join
- Having a pathological history and radiological findings pointing to secondary dysmenorrhea, Using oral contraceptives/antidepressants at least 6 months, Receiving hormone therapy, Undergoing pelvic surgery, Pregnant, Giving birth, Using an intrauterine device, Having neurological, orthopedic and/or rheumatological diseases Having a history of ischemic heart disease (recently myocardial infarction, angina pectoralis, uncontrolled hypertension, etc.), Having a psychiatric disease, Having a history of malignancy
Trial locations and contacts
No sites are listed yet.
About this study
The aim of the study is to compare the effects of aerobic exercise and spinal stabilization exercises in women with primary dysmenorrhea (PD) complaints.
Read the detailed description
PD is the cramping pain that comes before or during a period. Different exercise approaches have positive effects in PD. Comparing the effects of these exercise approaches is needed to determine the effects on PD.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Aerobic exercise program, Spinal stabilization exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise programOther
Aerobic exercise will be performed under the supervision of a physiotherapist with a treadmill during 40-60 minutes 3 days a week for 8 weeks
Spinal stabilization exercise programOther
Spinal stabilization exercises will be performed with a physiotherapist during 40-60 minutes 3 days a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise group | Experimental | Aerobic exercise will be performed under the supervision of a physiotherapist with a treadmill during 40-60 minutes, 3 days a week for 8 weeks. Receives: Other: Aerobic exercise program |
| Stabilization exercise group | Active comparator | Spinal stabilization exercises will be performed with a physiotherapist during 40-60 minutes, 3 days a week for 8 weeks. Receives: Other: Spinal stabilization exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual pain intensity
Menstrual pain intensity will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "no pain", while "10" = "unbearable pain". Individuals will be asked to mark on a 10 cm straight line according to the level of pain they feel. Pain intensity will be recorded by measuring the distance between the beginning of the line and the marked place.
Measured: change from baseline at 8 weeks
Secondary outcomes (10)
Menstrual symptoms
Menstrual symptoms will be measured with the menstrual symptom questionnaire. Menstrual Symptom Questionnaire is a 24-item self-report scale and each item is scored between 1 (never) and 5 (always). An increase in the mean score indicates an increase in the severity of menstrual symptoms. The total score is 120 points.
Measured: change from baseline at 8 weeks
Impacts of academic/work performance
Impacts of academic/work performance will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0"= means "my work/school performance is not affected in any way", while "10"= means "my work/school performance is greatly affected".
Measured: change from baseline at 8 weeks
Impacts of life quality
Impacts of life quality will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "my quality of life is not affected in any way", while "10" = "my quality of life is greatly affected". Individuals will be asked to mark on a 10 cm straight line according to the quality of life they think.
Measured: change from baseline at 8 weeks
Functional and emotional effects
Functional and emotional effects will be evaluated with Functional and Emotional Dysmenorrhea Scale. Options in the 14-item scale are (1) not at all similar to my situation, (2) Not similar to my situation, (3) Both similar and not similar to my situation, (4) considered similar to my situation, (5) very similar to my situation. The total score range is between 14-70. As the scores obtained from the scale increase, the functional and emotional state of being affected by dysmenorrhea also increases.
Measured: change from baseline at 8 weeks
Sleep quality
Sleep quality will be evaluated with Jenkins Sleep Scale, which consists of 4 items. Each item is rated with a 6-point Likert Scale. The total score ranges from 0 to 20. An average of at least 4 or more is considered a sleep quality disorder.
Measured: change from baseline at 8 weeks
Trunk muscle endurances
Trunk muscle endurances will be evaluated with McGill's endurance tests. During the tests, individuals will be asked to maintain the determined positions and the elapsed time will be recorded in seconds. The test result is recorded in seconds.
Measured: change from baseline at 8 weeks
Posture
Posture will be evaluated with PostureScreen Mobile application. PostureScreen Mobile application is an application that evaluates posture anterior-posterior-lateral photographically and provides data by comparing deviations that can be seen in posture according to ideal standing posture.
Measured: change from baseline at 8 weeks
Pelvic tilt
Pelvic tilt will be evaluated with Palpation Meter (PALM) device. The PALM device is an inclinometer and a palpation meter consisting of two caliper arms, which are used to measure the lumbopelvic position and pelvic tilt.
Measured: change from baseline at 8 weeks
Functional capacity
Functional capacity will be evaluated with a 2 kilometer walking test. The time taken for walking is calculated by substituting the heart rate, body mass index and age at the end of walking. The result obtained is evaluated according to age and gender, and an appropriateness index is found.
Measured: change from baseline at 8 weeks
Subjective perception of improvement
Subjective perception of improvement will be evaluated with 4-item Likert-type scale (worse, same, better, improved).
Measured: After exercise program (at 8 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study startMar 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seyda toprak celenay, Ankara Yildirim Beyazıt University
- Investigators
- Seyda Toprak Celenay, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243927
- Sponsor's protocol ID
- 2022/02/08
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Aerobic Exercise and Spinal Stabilization Exercises in Women With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT05243927
- Acronym / sponsor ID
- 2022/02/08
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 17 Feb 2022 (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.
The aim of the study is to compare the effects of aerobic exercise and spinal stabilization exercises in women with primary dysmenorrhea (PD) complaints.
Detailed description
PD is the cramping pain that comes before or during a period. Different exercise approaches have positive effects in PD. Comparing the effects of these exercise approaches is needed to determine the effects on PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise group | Experimental | Other: Aerobic exercise programAerobic exercise will be performed under the supervision of a physiotherapist with a treadmill during 40-60 minutes, 3 days a week for 8 weeks. |
| Stabilization exercise group | Active comparator | Other: Spinal stabilization exercise programSpinal stabilization exercises will be performed with a physiotherapist during 40-60 minutes, 3 days a week for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with primary dysmenorrhea complaint according to the Primary Dysmenorrhea Consensus Guide, Over 18 years of age, Having a mean pain intensity of moderate and higher according to the Visual Analogue Scale in the last 6 months, Having a regular menstrual cycle (28±7 days), Volunteered to participate in the study.
Key exclusion criteria (1 listed)
- Having a pathological history and radiological findings pointing to secondary dysmenorrhea, Using oral contraceptives/antidepressants at least 6 months, Receiving hormone therapy, Undergoing pelvic surgery, Pregnant, Giving birth, Using an intrauterine device, Having neurological, orthopedic and/or rheumatological diseases Having a history of ischemic heart disease (recently myocardial infarction, angina pectoralis, uncontrolled hypertension, etc.), Having a psychiatric disease, Having a history of malignancy
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 |
|---|---|---|
| Aerobic exercise programAerobic exercise will be performed under the supervision of a physiotherapist with a treadmill during 40-60 minutes 3 days a week for 8 weeks | Other | Aerobic exercise group |
| Spinal stabilization exercise programSpinal stabilization exercises will be performed with a physiotherapist during 40-60 minutes 3 days a week for 8 weeks. | Other | Stabilization exercise group |
Primary outcome
Menstrual pain intensity
Time frame: change from baseline at 8 weeks
Menstrual pain intensity will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "no pain", while "10" = "unbearable pain". Individuals will be asked to mark on a 10 cm straight line according to the level of pain they feel. Pain intensity will be recorded by measuring the distance between the beginning of the line and the marked place.
10 secondary outcomes
Menstrual symptoms
Time frame: change from baseline at 8 weeks
Impacts of academic/work performance
Time frame: change from baseline at 8 weeks
Impacts of life quality
Time frame: change from baseline at 8 weeks
Functional and emotional effects
Time frame: change from baseline at 8 weeks
Sleep quality
Time frame: change from baseline at 8 weeks
Trunk muscle endurances
Time frame: change from baseline at 8 weeks
Posture
Time frame: change from baseline at 8 weeks
Pelvic tilt
Time frame: change from baseline at 8 weeks
Functional capacity
Time frame: change from baseline at 8 weeks
Subjective perception of improvement
Time frame: After exercise program (at 8 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
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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.
Seyda Toprak Celenay principal investigator
Ankara Yildirim Beyazıt University
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise program and Spinal stabilization exercise program in people with Primary Dysmenorrhea, run by Ankara Yildirim Beyazıt University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda Toprak Celenay (+90312 906 1000, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual pain intensity (time frame: change from baseline at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2022.